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Letter to the Editor
The Carlos III Research Institute and registration of clinical trials with non-regulated interventions
El Instituto de Salud Carlos III y el registro de ensayos clínicos con intervenciones no reguladas
Rafael Dal-Ré
Unidad de Epidemiología, Instituto de Investigación Sanitaria-Hospital Universitario Fundación Jiménez Díaz, Universidad Autónoma de Madrid, Madrid, Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">In 2017&#44; this journal<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> reported on the &#34;Joint Statement&#34;&#44; a major initiative taken in May of that year by 12 clinical trial funders and published by the World Health Organization &#40;WHO&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> Following the path initiated by the <span class="elsevierStyleItalic">National Institutes of Health</span> of the USA <span class="elsevierStyleItalic">in January 2017&#44; these 12 funders</span><span class="elsevierStyleGlyphsbnd"></span><span class="elsevierStyleItalic">including the</span> Medical Research Council <span class="elsevierStyleItalic">of the UK</span>&#44; the Institut Pasteur and the Bill and Melinda Gates Foundation<span class="elsevierStyleGlyphsbnd"></span> made a committed that&#44; by May 2018&#44; researchers receiving funding would have to comply with the 2 basic requirements that ensure the transparency of clinical trials&#58; registration and public disclosure of results&#46; This commitment is particularly aimed at clinical trials evaluating non-regulated interventions &#40;e&#46;g&#46;&#44; physiotherapy&#44; diet&#44; psychotherapy&#41;&#44; as clinical trials with regulated interventions &#40;medicines and medical devices&#41; have had their own specific regulations for many years&#46; There are currently 23 funding institutions adhering to the Joint Statement&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">The Joint Statement outlines 10 key requirements for effective clinical trial transparency&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> Seven of these are duties of the researchers and three are duties of the funders&#46; Among the first&#44; 4 relate to the registration of the trial&#58; it must be prospective &#40;i&#46;e&#46;&#44; before the start of the trial&#41; and done in a registry &#40;open and free access&#41; that meets WHO criteria&#44; the information must be kept up to date&#44; and the results &#40;a summary&#41; and the trial protocol must be included in the registry within 12 months from the last visit of the last trial participant&#46; Three relate to publication of results&#58; publication must occur in a peer-reviewed journal within 24 months of trial completion&#44; the registry ID code must be used on all publications&#44; and&#44; whenever possible&#44; the publication must be open access&#46; Funders&#39; duties are to monitor that trials are registered and that results are made public&#44; and to take into account the reporting of previous trial results when assessing new funding proposals&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">The degree to which the 21 largest public funders in individual European countries met these 10 requirements in 2021 has recently become known&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> The results are discouraging&#58; Four is the average number of criteria met&#46; Fourteen funders &#40;67&#37;&#41; require prospective registration&#44; 9 &#40;43&#37;&#41; monitor that trials are registered&#44; 8 &#40;38&#37;&#41; that results are published and 6 &#40;29&#37;&#41; that results are included in the registry within 12 months of trial completion&#46; Only 3 &#40;14&#37;&#41; considered imposing sanctions for non-compliance&#46; The funders that require compliance with a greater number of criteria are the <span class="elsevierStyleItalic">National Institute for Health Research</span> and the <span class="elsevierStyleItalic">Medical Research Council</span>&#44; both from the UK&#44; and the <span class="elsevierStyleItalic">Research Council</span> from Norway&#46; <span class="elsevierStyleItalic">INSERM</span> &#40;France&#41; and <span class="elsevierStyleItalic">Swedish Research Council</span> were among the worst &#8212;but they have issued regulations that now place them among the funders that require compliance with a greater number of requirements&#8212;&#46;<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4&#44;5</span></a> The Institute of Health Carlos III &#40;ISCIII&#41; only requires researchers to publish results in open access&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Although an increasing number of ISCIII-funded researchers register clinical trials evaluating non-regulated interventions&#44; this is far from common practice&#46; In addition&#44; among the registered trials&#44; it is common not to comply with the requirements of the Joint Statement &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; In order to join Europe&#39;s largest public funders&#44; the ISCIII should adhere to the Joint Statement&#46; A decision to be taken by the ISCIII is whether&#44; in addition to registering this type of trial in one of the primary registries of the WHO network&#44; it should also be registered in the Spanish registry &#40;REec&#41;&#46; The latter would fulfil the social value of trial registration in the country where the trial is conducted&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0025" class="elsevierStylePara elsevierViewall">The ISCIII should develop a communication plan on the Joint Statement&#39;s requirements for researchers&#46; This could be done by making available to them an online training programme on what the requirements are and the reasons behind them&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interests</span><p id="par0030" class="elsevierStylePara elsevierViewall">The author declares that he has no conflict of interest&#46;</p></span></span>"
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">8 months and 3 weeks before its start&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">Some days before&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">Study in progress&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"><span class="elsevierStyleGlyphsbnd"></span>&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">Prehabilitation&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">Liver transplant&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">14 months before its start&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">Almost a year before&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">Study in progress&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"><span class="elsevierStyleGlyphsbnd"></span>&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">Web tool&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">Pregnancy&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">6 months and 3 weeks before its start&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">14 months and 2 weeks before&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">Recruitment not started&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"><span class="elsevierStyleGlyphsbnd"></span>&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">Physical exercise and transcranial electrical stimulation&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">Disability in aging&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">5 months and 3 weeks before its start&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">13 months and a few days before&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">Study in progress&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"><span class="elsevierStyleGlyphsbnd"></span>&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">Comprehensive cognitive rehabilitation&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">Major depression&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 months and 3 weeks after start&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">Almost 4 years before&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">The registry does not report whether participants are being recruited&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">Published in 2019&#46; Includes the registration ID code&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">Convalescent hyperimmune plasma&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">COVID-19&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">11 days after start<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">b</span></a>&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">5 weeks after the trial was completed&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">Not available in the registry&#46; Published in 2021&#44; on time and in a peer-reviewed journal&#46; Includes the registration ID code&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">Accessible as a supplement to the article&#44; but not available in the registry&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">Physical exercise and cognitive stimulation&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">Falls in frail patients&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">3 months after start&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">14 months and a few days before&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">Study in progress&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">Released in 2022&#46; Includes the registration ID code&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
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                      "titulo" => "2017&#44; un a&#241;o clave en la transparencia de los ensayos cl&#237;nicos"
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                        0 => array:2 [
                          "etal" => false
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                      "doi" => "10.1016/j.medcli.2017.06.053"
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                        "fecha" => "2018"
                        "volumen" => "150"
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                  "referenciaCompleta" => "World Health Organization&#46; Joint statement on public disclosure of results from clinical trials&#46; 18 May 2017&#46; &#91;accessed 8 Aug 2022&#93;&#46; Available from&#58; <a target="_blank" href="https://www.who.int/news/item/18-05-2017-joint-statement-on-registration">https&#58;&#47;&#47;www&#46;who&#46;int&#47;news&#47;item&#47;18-05-2017-joint-statement-on-registration</a>&#46;"
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                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Adoption of World Health Organization best practices in clinical trial transparency among European medical research funder policies"
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                          "autores" => array:4 [
                            0 => "T&#46; Bruckner"
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              "etiqueta" => "4"
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                  "referenciaCompleta" => "INSERM&#46; Clinical research at INSERM&#58; quality and transparency &#40;June 2021&#41;&#46; &#91;accessed 8 Aug 2022&#93;&#46; Available from&#58; <a target="_blank" href="https://www.inserm.fr/wp-content/uploads/inserm-rechercheclinique-qualitetransparence-juin2021-en.pdf">https&#58;&#47;&#47;www&#46;inserm&#46;fr&#47;wp-content&#47;uploads&#47;inserm-rechercheclinique-qualitetransparence-juin2021-en&#46;pdf</a>&#46;"
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              "etiqueta" => "5"
              "referencia" => array:1 [
                0 => array:1 [
                  "referenciaCompleta" => "Swedish Research Council&#46; Registering your clinical study&#46; &#91;accessed 8 Aug 2022&#93;&#46; Available from&#58; <a target="_blank" href="https://www.vr.se/english/applying-for-funding/requirements-terms-and-conditions/registering-your-clinical-study.html">https&#58;&#47;&#47;www&#46;vr&#46;se&#47;english&#47;applying-for-funding&#47;requirements-terms-and-conditions&#47;registering-your-clinical-study&#46;html</a>&#46;"
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ISSN: 23870206
Original language: English
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