Access to the results of non-commercial clinical trials with medicines conducted in Spain

Dal-Ré, R.

doi:10.1016/j.rceng.2021.05.006

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Dal-Ré" "autores" => array:1 [ 0 => array:3 [ "nombre" => "R." "apellidos" => "Dal-Ré" "email" => array:1 [ 0 => "Rafael.dalre@quironsalud.es" ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Unidad de Epidemiología, Instituto de Investigación Sanitaria-Hospital Universitario Fundación Jiménez Díaz, Universidad Autónoma de Madrid, Madrid, Spain" "identificador" => "aff0005" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Acceso a los resultados de los ensayos clínicos no comerciales con medicamentos realizados en España" ] ] "textoCompleto" => "Since 2016, European regulations have required sponsors of clinical drug trials to report the results obtained, uploading them to the European Clinical Trials Register (EU-CTR)<a class="elsevierStyleCrossRef" href="#bib0005">1</a>. This is the only way citizens in any country can openly and freely access results that would otherwise not be available to many, even if the results are published in scientific journals. The European Union’s commitment to transparency requires that it be possible to access clinical trials within one year of the trial’s conclusion<a class="elsevierStyleCrossRef" href="#bib0005">1</a>.The EU Trials Tracker (designed by DataLab, from Oxford University) is a tool that allows for determining on a monthly basis whether each of the trials registered in the EU-CTR has uploaded its results or not and if they contain inconsistent data, omissions, or errors. A study conducted using data from January 2018 showed that only half of those which were required to report results (n = 7,274) had done so<a class="elsevierStyleCrossRef" href="#bib0010">2</a>. In May 2021, this percentage rose to 70% of the 13,709 clinical trials that were required to report results<a class="elsevierStyleCrossRef" href="#bib0015">3</a>. However, there are still a large number of studies (n = 4089) whose results are not accessible.An analysis conducted in September 2018 demonstrated that there are hundreds of non-commercial clinical drug trial sponsors in our country, many of which are individual investigators. At that time, there were 28 sponsors who had ten or more clinical trials registered in the EU-CTR with a total of 689 studies registered, of which 23 studies were required to have uploaded their results to EU-CTR, yet it had not been done. In addition, 25% (173 of 689) of the trials had inconsistencies, errors, or omissions<a class="elsevierStyleCrossRef" href="#bib0020">4</a>.Recently, a group of 18 European organizations sent a letter to European regulators urging them to take action against sponsors who do not comply with regulations regarding public access to clinical trials results<a class="elsevierStyleCrossRef" href="#bib0025">5</a>. This situation, they concluded, had the “potential to harm European patients, taxpayers, and public health”<a class="elsevierStyleCrossRef" href="#bib0025">5</a>.Along the lines of this initiative, it is interesting to see what these 28 sponsors did regarding this matter: Were the results of their trials uploaded to the EU-CTR? And, regarding all the trials they sponsor, were inconsistencies in the information corrected? Let's not forget that these two aspects decisively influence the quality of information accessible to citizens, investigators, and prescribers.In May 2021, the 28 sponsors had registered 801 trials (16% more than in September 2018), of which 75 trials should have uploaded their results to the EU-CTR (a 226% increase). In <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>, the 28 sponsors are classified as: (a) those which reported the results of all or some of their clinical trials (n = 9); (b) those which have not reported the results despite having the obligation to do so (n = 15); and (c) those which do not have to do so yet, either because the trial has not concluded yet or, though the trial may have concluded, one year has not yet passed since its conclusion (n = 4).<elsevierMultimedia ident="tbl0005"></elsevierMultimedia>It should be noted that of the nine “compliant” sponsors, seven are collaborative oncology groups; another is the San Carlos Clinical Hospital of Madrid; and the last is the Progress and Health Andalusian Public Foundation, the central body for supporting and managing research in the Andalusian Public Healthcare System. Unfortunately, in May 2021, the results of just 25% (19 of 75) trials were uploaded to the EU-CTR out of the trials that had the obligation to do so. It is notable to observe that among the “non-compliant” sponsors are the nine hospitals that sponsor the highest number of trials (between 28 and 113) and which should have reported the results of 45 studies.The percentage of trials with inconsistencies in information is similar among the three sponsor groups (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>). Twenty-four percent (194 of 801) of trials had inconsistencies, a percentage which has not varied since September 2018, when it was 25%<a class="elsevierStyleCrossRef" href="#bib0020">4</a>. This is not very reassuring, given that inconsistencies depend on those who are responsible for data entry. The errors and omissions in information observed in the EU-CTR may denote a certain lack of attention to this task or, on occasion, that they are performed by people without enough training.It is worrying to observe that hospitals with extensive experience in conducting clinical trials have a high degree of non-compliance. What’s more, they are centers that have stable structures (for example: a clinical trials unit or the like) which should help and remind investigators of the need to include the results of trials in the EU-CTR.Clinical trial results should be considered a public good and thus, they should be within the reach of anyone. It should not be forgotten that even if there is a growing number of open access scientific articles published—that is, those that are free and open to access—, there are still many that are available only via subscription. Indeed, it has been calculated that just 22% of all articles on medicine are open access<a class="elsevierStyleCrossRef" href="#bib0030">6</a>.Including clinical trials results in the EU-CTR as per European regulations ensures that any person anywhere in the world can access them within 12 months of the trial's conclusion. Uploading results in other databases where the trial has also been registered, such as the Spanish database (REec) or that of the United States of America (ClinicalTrials.gov), should not exempt sponsors from the obligation to upload the results to the EU-CTR, where patients, investigators, and clinicians can expect to find the results of any trial conducted in Spain.FundingThis work did not require any funding.Conflicts of interestNone to declare." 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entry_with_role_rowhead " colspan="5" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">a) Sponsors who reported clinical trials results</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Gastrointestinal Tumor Treatment Group (TTD, for its initials in Spanish) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">26 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">100 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">10 (39) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">San Carlos Clinical Hospital, Madrid \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">100 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 (12) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Spanish Lung Cancer Group (GECP) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">100 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 (24) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Spanish Sarcoma Research Group (GEIS) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">15 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">100 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 (13) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Spanish Multidisciplinary Gastrointestinal Cancer Group (GEMCAD) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">14 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">100 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 (21) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Progress and Health Andalusian Public Foundation \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">24 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">80 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">7 (29) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Spanish Breast Cancer Research Group (GEICAM) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">66.7 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 (12) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Spanish Neuroendocrine Tumor Group (GETNE) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">12 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">50 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 (25) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Spanish Ovarian Cancer Research Group (GEICO) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">16 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">33.3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 (13) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Subtotal \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">158 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">24 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">75 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">35 (22) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="5" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"></td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " colspan="5" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">b) Sponsors who did not report clinical trials results</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Clinical Hospital,<a class="elsevierStyleCrossRef" href="#tblfn0015">c</a> Barcelona \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">113 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">7 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">34 (30) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Vall d’Hebron Hospital, Barcelona \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">63 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">12 (19) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Santa Creu i Sant Pau Hospital, Barcelona \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">61 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">10 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">13 (21) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Bellvitge Hospital, L’Hospitalet de Llobregat \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">47 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">9 (19) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">La Paz Hospital, Madrid \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">46 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">8 (17) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">University of Navarre, Pamplona \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">45 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">10 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">14 (31) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Parc de Salut Mar, Barcelona \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">38 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 (11) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Gregorio Marañón Hospital, Madrid \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">30 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5 (17) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">La Fe Healthcare Research Institute, Valencia \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">28 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">7 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">12 (43) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Andalusian Public Foundation for Health Research Management of Seville (FISEVI)<a class="elsevierStyleCrossRef" href="#tblfn0020">d</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">26 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">6 (23) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Ramón y Cajal Hospital, Madrid \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">25 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">9 (36) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Spanish Lymphoma and Autologous Bone Marrow Transplant Group (GELTAMO) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">20 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">10 (50) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Valencian Infertility Institute (IVI), Valencia \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">18 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 (22) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Foundation for Healthcare Training and Research (FFIS),<a class="elsevierStyleCrossRef" href="#tblfn0025">e</a> Murcia \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 (18) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Aragon Institute for Health Sciences (IACS),<a class="elsevierStyleCrossRef" href="#tblfn0030">f</a> Zaragoza \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">11 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 (36) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Subtotal \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">588 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">51 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">147 (25) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="5" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"></td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " colspan="5" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">c) Sponsors who did not have to report any clinical trial results in May 2021</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Andalusian Public Foundation for Biomedical and Health Research (FIMABIS)<a class="elsevierStyleCrossRef" href="#tblfn0035">g</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">19 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 (16) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; 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On the other hand, to determine how many trials are sponsored from a specific hospital, you must add those sponsored by the hospital itself/foundation and those that appear in the EU-CTR as sponsored by the individual investigators. This may notably change the data on this table. For example, Dr. Podzamczer is the sponsor of seven clinical trials, which would be in addition to those sponsored by the Bellvitge Hospital itself." ] 1 => array:3 [ "identificador" => "tblfn0010" "etiqueta" => "b" "nota" => "Some trials have inconsistencies, omissions, or errors in the EU-CRT such that it cannot be known for certain whether the results were required to be reported or not—that is, uploaded to the EU-CTR registry. The most common error was indicating that the trial has been completed, but not indicating the date when this occurred. 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Who is not sharing clinical trials results? [Accessed 25 May 2021]. Available from: <a target="_blank" href="http://eu.trialstracker.net/">http://eu.trialstracker.net/</a>." ] ] ] 3 => array:3 [ "identificador" => "bib0020" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "¿Quiénes son los promotores españoles de un mayor número de ensayos clínicos no comerciales con medicamentos y de la comunicación de sus resultados?" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "R. Dal-Ré" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "Med Clin (Barc)" "fecha" => "2019" "volumen" => "153" "paginaInicial" => "e3" "paginaFinal" => "e4" ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0025" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "TranspariMED. HMA Management Group. Heads of medicines agencies permanent secretariat. 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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Since 2016&#44; European regulations have required sponsors of clinical drug trials to report the results obtained&#44; uploading them to the European Clinical Trials Register &#40;EU-CTR&#41;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46; This is the only way citizens in any country can openly and freely access results that would otherwise not be available to many&#44; even if the results are published in scientific journals&#46; The European Union&#8217;s commitment to transparency requires that it be possible to access clinical trials within one year of the trial&#8217;s conclusion<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">The EU Trials Tracker &#40;designed by DataLab&#44; from Oxford University&#41; is a tool that allows for determining on a monthly basis whether each of the trials registered in the EU-CTR has uploaded its results or not and if they contain inconsistent data&#44; omissions&#44; or errors&#46; A study conducted using data from January 2018 showed that only half of those which were required to report results &#40;n&#8239;&#61;&#8239;7&#44;274&#41; had done so<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a>&#46; In May 2021&#44; this percentage rose to 70&#37; of the 13&#44;709 clinical trials that were required to report results<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a>&#46; However&#44; there are still a large number of studies &#40;n&#8239;&#61;&#8239;4089&#41; whose results are not accessible&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">An analysis conducted in September 2018 demonstrated that there are hundreds of non-commercial clinical drug trial sponsors in our country&#44; many of which are individual investigators&#46; At that time&#44; there were 28 sponsors who had ten or more clinical trials registered in the EU-CTR with a total of 689 studies registered&#44; of which 23 studies were required to have uploaded their results to EU-CTR&#44; yet it had not been done&#46; In addition&#44; 25&#37; &#40;173 of 689&#41; of the trials had inconsistencies&#44; errors&#44; or omissions<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a>&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Recently&#44; a group of 18 European organizations sent a letter to European regulators urging them to take action against sponsors who do not comply with regulations regarding public access to clinical trials results<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a>&#46; This situation&#44; they concluded&#44; had the &#8220;potential to harm European patients&#44; taxpayers&#44; and public health&#8221;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a>&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Along the lines of this initiative&#44; it is interesting to see what these 28 sponsors did regarding this matter&#58; Were the results of their trials uploaded to the EU-CTR&#63; And&#44; regarding all the trials they sponsor&#44; were inconsistencies in the information corrected&#63; Let&#39;s not forget that these two aspects decisively influence the quality of information accessible to citizens&#44; investigators&#44; and prescribers&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">In May 2021&#44; the 28 sponsors had registered 801 trials &#40;16&#37; more than in September 2018&#41;&#44; of which 75 trials should have uploaded their results to the EU-CTR &#40;a 226&#37; increase&#41;&#46; In <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#44; the 28 sponsors are classified as&#58; &#40;a&#41; those which reported the results of all or some of their clinical trials &#40;n&#8239;&#61;&#8239;9&#41;&#59; &#40;b&#41; those which have not reported the results despite having the obligation to do so &#40;n&#8239;&#61;&#8239;15&#41;&#59; and &#40;c&#41; those which do not have to do so yet&#44; either because the trial has not concluded yet or&#44; though the trial may have concluded&#44; one year has not yet passed since its conclusion &#40;n&#8239;&#61;&#8239;4&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">It should be noted that of the nine &#8220;compliant&#8221; sponsors&#44; seven are collaborative oncology groups&#59; another is the San Carlos Clinical Hospital of Madrid&#59; and the last is the Progress and Health Andalusian Public Foundation&#44; the central body for supporting and managing research in the Andalusian Public Healthcare System&#46; Unfortunately&#44; in May 2021&#44; the results of just 25&#37; &#40;19 of 75&#41; trials were uploaded to the EU-CTR out of the trials that had the obligation to do so&#46; It is notable to observe that among the &#8220;non-compliant&#8221; sponsors are the nine hospitals that sponsor the highest number of trials &#40;between 28 and 113&#41; and which should have reported the results of 45 studies&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">The percentage of trials with inconsistencies in information is similar among the three sponsor groups &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; Twenty-four percent &#40;194 of 801&#41; of trials had inconsistencies&#44; a percentage which has not varied since September 2018&#44; when it was 25&#37;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a>&#46; This is not very reassuring&#44; given that inconsistencies depend on those who are responsible for data entry&#46; The errors and omissions in information observed in the EU-CTR may denote a certain lack of attention to this task or&#44; on occasion&#44; that they are performed by people without enough training&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">It is worrying to observe that hospitals with extensive experience in conducting clinical trials have a high degree of non-compliance&#46; What&#8217;s more&#44; they are centers that have stable structures &#40;for example&#58; a clinical trials unit or the like&#41; which should help and remind investigators of the need to include the results of trials in the EU-CTR&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Clinical trial results should be considered a public good and thus&#44; they should be within the reach of anyone&#46; It should not be forgotten that even if there is a growing number of open access scientific articles published&#8212;that is&#44; those that are free and open to access&#8212;&#44; there are still many that are available only via subscription&#46; Indeed&#44; it has been calculated that just 22&#37; of all articles on medicine are open access<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a>&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Including clinical trials results in the EU-CTR as per European regulations ensures that any person anywhere in the world can access them within 12 months of the trial&#39;s conclusion&#46; Uploading results in other databases where the trial has also been registered&#44; such as the Spanish database &#40;REec&#41; or that of the United States of America &#40;ClinicalTrials&#46;gov&#41;&#44; should not exempt sponsors from the obligation to upload the results to the EU-CTR&#44; where patients&#44; investigators&#44; and clinicians can expect to find the results of any trial conducted in Spain&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Funding</span><p id="par0060" class="elsevierStylePara elsevierViewall">This work did not require any funding&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflicts of interest</span><p id="par0065" class="elsevierStylePara elsevierViewall">None to declare&#46;</p></span></span>"
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                  \t\t\t\t">100&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">4 &#40;24&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Spanish Sarcoma Research Group &#40;GEIS&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Spanish Multidisciplinary Gastrointestinal Cancer Group &#40;GEMCAD&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Progress and Health Andalusian Public Foundation&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Spanish Breast Cancer Research Group &#40;GEICAM&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Spanish Neuroendocrine Tumor Group &#40;GETNE&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Spanish Ovarian Cancer Research Group &#40;GEICO&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Subtotal&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">158&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t ; entry_with_role_rowhead " colspan="5" align="left" valign="\n
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                  \t\t\t\t">b&#41; <span class="elsevierStyleItalic">Sponsors who did not report clinical trials results</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Clinical Hospital&#44;<a class="elsevierStyleCrossRef" href="#tblfn0015"><span class="elsevierStyleSup">c</span></a> Barcelona&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">113&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">34 &#40;30&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Vall d&#8217;Hebron Hospital&#44; Barcelona&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">63&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">12 &#40;19&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Santa Creu i Sant Pau Hospital&#44; Barcelona&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">61&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">13 &#40;21&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Bellvitge Hospital&#44; L&#8217;Hospitalet de Llobregat&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">47&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">9 &#40;19&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>La Paz Hospital&#44; Madrid&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">8 &#40;17&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>University of Navarre&#44; Pamplona&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">14 &#40;31&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Parc de Salut Mar&#44; Barcelona&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Gregorio Mara&#241;&#243;n Hospital&#44; Madrid&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>La Fe Healthcare Research Institute&#44; Valencia&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Andalusian Public Foundation for Health Research Management of Seville &#40;FISEVI&#41;<a class="elsevierStyleCrossRef" href="#tblfn0020"><span class="elsevierStyleSup">d</span></a>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Ram&#243;n y Cajal Hospital&#44; Madrid&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Spanish Lymphoma and Autologous Bone Marrow Transplant Group &#40;GELTAMO&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Valencian Infertility Institute &#40;IVI&#41;&#44; Valencia&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Foundation for Healthcare Training and Research &#40;FFIS&#41;&#44;<a class="elsevierStyleCrossRef" href="#tblfn0025"><span class="elsevierStyleSup">e</span></a> Murcia&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Aragon Institute for Health Sciences &#40;IACS&#41;&#44;<a class="elsevierStyleCrossRef" href="#tblfn0030"><span class="elsevierStyleSup">f</span></a> Zaragoza&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Subtotal&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">c&#41; <span class="elsevierStyleItalic">Sponsors who did not have to report any clinical trial results in May 2021</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Andalusian Public Foundation for Biomedical and Health Research &#40;FIMABIS&#41;<a class="elsevierStyleCrossRef" href="#tblfn0035"><span class="elsevierStyleSup">g</span></a>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">3 &#40;16&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Catalan Oncology Institute &#40;ICO&#41;&#44; Barcelona&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">4 &#40;31&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Canary Islands University Hospital&#44; Santa Cruz de Tenerife&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">1 &#40;8&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>University of Valladolid&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttop\n
                  \t\t\t\t">&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">4 &#40;36&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Subtotal&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">55&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">12 &#40;22&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Total</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">801&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">75&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">194 &#40;24&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
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              "nota" => "<p class="elsevierStyleNotepara" id="npar0005">In regard to hospitals&#44; many of the sponsors are their own foundations&#46; On the other hand&#44; to determine how many trials are sponsored from a specific hospital&#44; you must add those sponsored by the hospital itself&#47;foundation and those that appear in the EU-CTR as sponsored by the individual investigators&#46; This may notably change the data on this table&#46; For example&#44; Dr&#46; Podzamczer is the sponsor of seven clinical trials&#44; which would be in addition to those sponsored by the Bellvitge Hospital itself&#46;</p>"
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            ]
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              "nota" => "<p class="elsevierStyleNotepara" id="npar0020">Reference hospitals&#58; Virgen del Roc&#237;o&#44; Virgen de la Macarena&#44; and Nuestra Se&#241;ora de Valme Hospital Complex &#40;Seville&#41;&#46;</p>"
            ]
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              "etiqueta" => "f"
              "nota" => "<p class="elsevierStyleNotepara" id="npar0030">Reference hospitals&#58; Lozano Blesa Clinical Hospital and Miguel Servet &#40;Zaragoza&#41;&#46;</p>"
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            6 => array:3 [
              "identificador" => "tblfn0035"
              "etiqueta" => "g"
              "nota" => "<p class="elsevierStyleNotepara" id="npar0035">This entity manages public hospitals in M&#225;laga province except for the Costa del Sol Hospital &#40;Marbella&#41;&#46;</p>"
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        ]
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          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Spanish sponsors<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a> in the European Clinical Trials Registry &#40;EU-CRT&#41;&#44; according to whether they reported the results of the clinical trials or not&#46; Data from May 10&#44; 2021&#46;</p>"
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      ]
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                  "referenciaCompleta" => "Directriz de la Comisi&#243;n&#46; Orientaciones sobre el registro y la publicaci&#243;n de informaci&#243;n relativa a los resultados de ensayos cl&#237;nicos en relaci&#243;n con la aplicaci&#243;n del art&#237;culo 57&#44; apartado 2&#44; del Reglamento &#40;CE&#41; n 726&#47;2004 y el art&#237;culo 41&#44; apartado 2&#44; del Reglamento &#40;CE&#41; n 1901&#47;2006 &#40;2012&#47;C 302&#47;03&#41;&#46; Diario Oficial de la Uni&#243;n Europea&#46; 6&#46;10&#46;2012&#46; C 302&#47;7-10 &#91;Accessed 25 May 2021&#93;&#46; Available from&#58; <a target="_blank" href="https://eur-lex.europa.eu/legal-content/ES/TXT/PDF/?uri=CELEX:52012XC1006(01)&amp;from=PL">https&#58;&#47;&#47;eur-lex&#46;europa&#46;eu&#47;legal-content&#47;ES&#47;TXT&#47;PDF&#47;&#63;uri&#61;CELEX&#58;52012XC1006&#40;01&#41;&#38;from&#61;PL</a>&#46;"
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              "etiqueta" => "2"
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                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Compliance with requirement to report results on the EU Clinical Trials Register&#58; cohort study and web resource"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "B&#46; Goldacre"
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                            3 => "F&#46; Irving"
                            4 => "S&#46; Bacon"
                            5 => "J&#46; Fleminger"
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                  "host" => array:1 [
                    0 => array:1 [
                      "Revista" => array:3 [
                        "tituloSerie" => "BMJ"
                        "fecha" => "2018"
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            2 => array:3 [
              "identificador" => "bib0015"
              "etiqueta" => "3"
              "referencia" => array:1 [
                0 => array:1 [
                  "referenciaCompleta" => "EMB DataLab&#44; University of Oxford&#46; Who is not sharing clinical trials results&#63; &#91;Accessed 25 May 2021&#93;&#46; Available from&#58; <a target="_blank" href="http://eu.trialstracker.net/">http&#58;&#47;&#47;eu&#46;trialstracker&#46;net&#47;</a>&#46;"
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            3 => array:3 [
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              "etiqueta" => "4"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "&#191;Qui&#233;nes son los promotores espa&#241;oles de un mayor n&#250;mero de ensayos cl&#237;nicos no comerciales con medicamentos y de la comunicaci&#243;n de sus resultados&#63;"
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                    0 => array:1 [
                      "Revista" => array:5 [
                        "tituloSerie" => "Med Clin &#40;Barc&#41;"
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                        "volumen" => "153"
                        "paginaInicial" => "e3"
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              "identificador" => "bib0025"
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              "referencia" => array:1 [
                0 => array:1 [
                  "referenciaCompleta" => "TranspariMED&#46; HMA Management Group&#46; Heads of medicines agencies permanent secretariat&#46; Improving clinical trial sponsors&#8217; compliance with CTIMP results reporting requirements &#91;Accessed 25 May 2021&#93;&#46; Available from&#58; <a target="_blank" href="https://www.transparimed.org/single-post/ctimps-results-reporting">https&#58;&#47;&#47;www&#46;transparimed&#46;org&#47;single-post&#47;ctimps-results-reporting</a>&#46;"
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                      "titulo" => "Adoption of the open access business model in scientific journal publishing&#58; a cross-disciplinary study"
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                        0 => array:2 [
                          "etal" => false
                          "autores" => array:2 [
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                      "Revista" => array:5 [
                        "tituloSerie" => "Coll Res Lib"
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