Medical research funders like the Wellcome Trust, the Bill and Melinda Gates Foundation, and others are getting serious about clinical trial transparency. On May 18, 2017, several of the world’s largest funders of medical research issued a Joint Statement on Public Disclosure of Results from Clinical Trials. In the joint statement, the 12 participating groups pledge to implement policies with mandated timeframes for registering and providing summary results for all interventional studies stating that:
The signatories of this joint statement affirm that the prospective registration and timely public disclosure of results from all clinical trials is of critical scientific and ethical importance. Furthermore timely results disclosure reduces waste in research, increases value and efficiency in use of funds and reduces reporting bias, which should lead to better decision-making in health.
Sponsors and investigators that receive funding from one of these organizations are expected to adhere to the standards outlined in the joint statement. All interventional clinical studies, regardless of phase or intervention type, are required to be registered and results disclosed and there is no geographic jurisdiction indicated. Studies must be registered proactively prior to the first participant receiving a medical intervention.
On the results side, the joint statement adopts the concept of primary study completion, known as the primary completion date from the U.S. regulations. This is the date the last data for the last participant was collected for the primary outcome measure(s), or the date last data was collected for terminated studies. In many cases, this occurs before the final study completion date. While this concept has been around since the Food and Drug Amendments Act (FDAAA) of 2007, sponsors or investigators outside of the U.S. may not be familiar with this concept and may need to consider adding this date to their protocol milestones.
According to the joint statement, summary results for the study must be publicly available within 12 months of the primary study completion date, regardless of the outcome. While the statement recognizes two methods for disclosing summary results, in a public registry or by journal publication, the statement focuses on disclosure on a public registry within this 12-month timeline as the publication timeline is not under the control of the sponsor or investigator. Journal publications are expected within 24 months of study completion, and should include the Trial ID in the abstract because it is “essential” to link back to registry records.
Aligning with current trends, the joint statement states that the protocol be made publicly available no later than the time that summary results are available. The protocol must include amendments that require an approval by an ethics committee (EC) or institutional review boards (IRB).
While the benefits of sharing Individual Patient Data (IPD) is recognized, the joint statement does not direct IPD to be shared. The funders will work with partners to develop ethical and legal frameworks to govern data sharing and use, as well as acceptable standards for sharing IPD.
For sponsors or investigators looking for funding, plans for registration and disclosure should be included in the grant submission, along with budgets that allocate reasonable funds to meeting these requirements. Registration and clinical trial results disclosure of previous trials will be considered when assessing a funding proposal. Investigators may be asked to list previous trials along with reporting status and explanations when trials are not registered or summary results are not disclosed as expected.
In addition to mandating timelines for study registration and results disclosure, the signatories pledge to monitor adherence to the timely registration and results disclosure and make the results of the monitoring public.
Disclosure continues to increase in complexity. TrialScope offers a full range of clinical trial disclosure, transparency, and data sharing solutions developed by domain experts. Learn more in our on-demand webinar: "The Global Disclosure Challenge: What You Need to Know".
TrialScope recently published 2 blogs on the risks and challenges of clinical trial transparency.
Visit the Resources section of our website to download complimentary educational resources including white papers, presentations and other useful tools.