Current policies of non‐commercial funders towards transparency in clinical trials - Dal‐Ré - European Journal of Clinical Investigation - Wiley Online Library

peter.suber's bookmarks 2024-02-25


"Transparency of clinical trials is one of the main objectives that any responsible trialist, sponsor or funder should meet. This should include all relevant aspects related to the design, conduct and dissemination of the results. Any trial should be prospectively registered (or preregistered) on a free to access public register and conducted according to the approved protocol (and relevant amendments). The results should be disseminated by timely (i.e. no later than 12 months after trial completion or termination) posting the finding on the register and by publishing them on a peer-reviewed journal. Finally, important documents needed to fully understand the trial, such as the protocol, statistical analysis plan and ideally the informed consent form, should be publicly available by posting them on the register or providing them as supplementary material to the published report. All these aspects are mandated for all US federally funded trials.12 All trials assessing regulated interventions (medicines, medical devices) supported by public or private funds must comply with all abovementioned aspects─except for posting of informed consent forms on the register—as per the US clinical trials regulations.1 Preregistration and timely posting of results on the register are mandatory for all trials assessing medicines conducted in the EU.3 Ethical guidelines,45 the International Committee of Medical Journal Editors6 and the WHO7 also request preregistration and public disclosure of trial findings assessing any type of intervention and regardless of the funder.

Several analyses have described how sponsors have complied with the transparency practices requested by current guidelines and regulations. Compliance with prospective drug trial registration is increasing but suboptimal; timely posting of trial results is worse.8-13 Commercial sponsors are significantly more compliant than non-commercial sponsors with regards to timely posting of drug trial results on registers.81314 Compliance by non-commercial sponsors is highly variable across European countries.15 Posting of trials documents is deficient.11 Finally, sharing of individual participant data—that would maximize the usefulness of clinical trials data, and is supported by funders and journal editors—is the exception rather than the norm...."



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Tags: oa.policies oa.funders oa.policies.funders oa.transparency oa.clinical_trials oa.medicine oa.pharma oa.paywalled oa.compliance oa.usa oa.preregistration oa.speed oa.negative oa.funders oa.best_practices oa.recommendations

Date tagged:

02/25/2024, 09:46

Date published:

02/25/2024, 04:46