Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK

Knowles, Rachel L; Ha, Kam Pou; Mueller, Julia; Rawle, Frances; Parker, R.

doi:10.1136/bmjopen-2019-035283

Cited by 14 publications

(16 citation statements)

References 32 publications

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“…Furthermore, public funders and institutional publication funds could demand that trial sponsors post their results before allocating funding for academic (open-access) publication. These funding bodies could also deny individual sponsors funding if they have violated clinical trial reporting rules in the past [37], an option currently being considered by some UK funding bodies. At the very least, journals should conform to the CONSORT statement in ensuring that registry identification numbers are clearly indicated in the abstract, full-text and meta-data of published clinical trials in order promote discoverability and record linkage between registries and publications [35].…”

Section: Discussionmentioning

confidence: 99%

Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs

Rodgers

Pepperrell

Keestra

et al. 2021

Trials

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Background Several drugs are being repurposed for the treatment of the coronavirus disease 2019 (COVID-19) pandemic based on in vitro or early clinical findings. As these drugs are being used in varied regimens and dosages, it is important to enable synthesis of existing safety data from clinical trials. However, availability of safety information is limited by a lack of timely reporting of overall clinical trial results on public registries or through academic publication. We aimed to analyse the evidence gap in this data by conducting a rapid review of results posting on ClinicalTrials.gov and in academic publications to quantify the number of trials missing results for drugs potentially being repurposed for COVID-19. Methods ClinicalTrials.gov was searched for 19 drugs that have been identified as potential treatments for COVID-19. Relevant clinical trials for any prior indication were listed by identifier (NCT number) and checked for results and for timely result reporting (within 395 days of the primary completion date). Additionally, PubMed and Google Scholar were searched to identify publications of results not listed on the registry. A second, blinded search of 10% of trials was conducted to assess reviewer concordance. Results Of 3754 completed trials, 1516 (40.4%) did not post results on ClinicalTrials.gov or in the academic literature. Tabular results were available on ClinicalTrials.gov for 1172 (31.2%) completed trials. A further 1066 (28.4%) had published results in the academic literature, but did not report results on ClinicalTrials.gov. Key drugs missing clinical trial results include hydroxychloroquine (37.0% completed trials unreported), favipiravir (77.8%) and lopinavir (40.5%). Conclusions There is an important evidence gap for the safety of drugs being repurposed for COVID-19. This uncertainty could cause unnecessary additional morbidity and mortality during the pandemic. We recommend caution in experimental drug use for non-severe disease and urge clinical trial sponsors to report missing results retrospectively.

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Section: Discussionmentioning

confidence: 99%

Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs

Rodgers

Pepperrell

Keestra

et al. 2021

Trials

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“…Such trials greatly outnumber trials of investigative medical products, and can be of equal or greater scientific and clinical importance; across Europe, they are most commonly registered on ClinicalTrials.gov , but also on other WHO primary registries such as ISRCTN and DRKS. Governments, regulatory agencies and research funders worldwide should extend registry reporting requirements to all interventional clinical trials as per WHO best practices [ 18 ]. We hope that our novel US clinical trials tracking tool ( clinical-trials-tracker.com ) will drive trial sponsors worldwide to exceed narrow regulatory compliance and fully implement WHO best practices to improve the completeness and accuracy of the medical evidence base and accelerate medical progress.…”

Section: Discussionmentioning

confidence: 99%

Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov—evaluation of a new tracking tool for the US clinical trial registry

Keestra

Rodgers

Lenz

et al. 2021

Trials

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Clinical trial transparency forms the foundation of evidence-based medicine, and trial sponsors, especially publicly funded institutions such as universities, have an ethical and scientific responsibility to make the results of clinical trials publicly available in a timely fashion. We assessed whether the thirty UK universities receiving the most Medical Research Council funding in 2017–2018 complied with World Health Organization best practices for clinical trial reporting on the US Clinical Trial Registry (ClinicalTrials.gov). Firstly, we developed and evaluated a novel automated tracking tool (clinical-trials-tracker.com) for clinical trials registered on ClinicalTrials.gov. This tracker identifies the number of due trials (whose completion lies more than 395 days in the past) that have not reported results on the registry and can now be used for all sponsors. Secondly, we used the tracker to determine the number of due clinical trials sponsored by the selected UK universities in October 2020. Thirdly, using the FDAAA Trials Tracker, we identified trials sponsored by these universities that are not complying with reporting requirements under the Food and Drug Administration Amendments Act 2007. Finally, we quantified the average and median number of days between primary completion date and results posting. In October 2020, the universities included in our study were sponsoring 1634 due trials, only 1.6% (n = 26) of which had reported results within a year of completion. 89.8% (n = 1468) of trials remained unreported, and 8.6% (n = 140) of trials reported results late. We also identified 687 trials that contained inconsistent data, suggesting that UK universities often fail to update their data adequately on ClinicalTrials.gov. The mean reporting delay after primary completion for trials that posted results was 981 days, the median 728 days. Only four trials by UK universities violated the FDAAA 2007. We suggest a number of reasons for the poor reporting performance of UK universities on ClinicalTrials.gov: (i) efforts to improve clinical trial reporting in the UK have to date focused on the European clinical trial registry (EU CTR), (ii) the absence of a tracking tool for timely reporting on ClinicalTrials.gov has limited the visibility of institutions’ reporting performance on the US registry and (iii) there is currently a lack of repercussions for UK sponsors who fail to report results on ClinicalTrials.gov which should be addressed in the future.

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“…A recent study [ 39 ] clarified that CTs published in ICMJE member journals were highly compliant, but prospective trial registrations were still low. Furthermore, with regard to CTR after completion of a study, recent studies found that faster registration has become widespread [ 40 , 41 ]. These two factors are important for showing transparency in registration requirements.…”

Section: Discussionmentioning

confidence: 99%

Compliance of Clinical Trial Protocols for Foods with Function Claims (FFC) in Japan: Consistency between Clinical Trial Registrations and Published Reports

Kamioka

Origasa

Kitayuguchi³

et al. 2021

Nutrients

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Background: A new type of foods with a health claims notification system, the Foods with Function Claims (FFC), was introduced in Japan in April 2015. This cross-sectional study sought to clarify compliance of clinical trial protocols reported as the scientific basis of efficacy in the FFC system. Methods: All articles based on clinical trials published on the Consumer Affairs Agency website from 1 July 2018 to 30 June 2021 were reviewed. Items assessed included first author characteristics (for-profit or academia), journal name, year published, journal impact factor in 2020, article language, name of clinical trial registration (CTR), and seven compliance items (Title: T, Participant: P, Intervention: I, Comparison: C, Outcome: O, Study design: S, and Institutional Review Board, IRB). Among studies that conducted CTR, consistency with these seven compliance items was evaluated. Results: Out of 136 studies that met all inclusion criteria, 103 (76%) performed CTR, and CTR was either not performed or not specified for 33 (24%). Compliance between the protocol and the text was high (≥96%) for items P and S, but considerably lower for items T, I, C, O, and IRB (52%, 15%, 13%, 69%, and 27%, respectively). Furthermore, 43% of protocols did not include functional ingredients or food names in items T or I. The total score was 3.7 ± 1.1 pts (out of 7). Conclusions: Some CTs had no protocol registration, and even registered protocols were suboptimal in transparency. In addition to selective reporting, a new problem identified was that the content of the intervention (test food) was intentionally concealed.

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Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK

Cited by 14 publications

References 32 publications

Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs

Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs

Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov—evaluation of a new tracking tool for the US clinical trial registry

Compliance of Clinical Trial Protocols for Foods with Function Claims (FFC) in Japan: Consistency between Clinical Trial Registrations and Published Reports

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