Researchers’ obligations to report clinical trial results are…
The Declaration of Helsinki, adopted by the World Medical Association in 1964, last amended in 2000, is the internationally agreed ethical standard for clinical researchers. It says that researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports.
It also says that ethical imperative to report includes results of unreported trials conducted in the past. And that: “Negative and inconclusive as well as positive results must be published”.
The World Health Organization states: “The registration of all interventional trials is a scientific, ethical and moral responsibility” and: “The key outcomes are to be made publicly available within 12 months of study completion by posting to the results section of the primary clinical trial registry.”1
All trials registered on the EU clinical trial register since 2004 must have results reported. The new EU regulation 536/2014 from 2019 will make this a legal requirement that can be enforced through fines and other sanctions.
The FDA Amendment Act 2007 requires that trials with a site in the US or forming part of treatment licensing, are registered on ClinicalTrials.gov and report results within 12 months of completion.
It can impose fines of up to $10,000 a day. In 2015 the United Nations began urging every government to ensure it has legal enforcement measures to require researchers to disclose clinical trial results.
Many of the world’s largest medical funders – including US NIH, the European commission, Australian NHMRC, foundations and patient NGOs – mandate that results from trials they fund must be reported.
Funders around the world are signing up to a WHO-led statement committing to audit their grants for compliance. This is one reason IRBs and other approval bodies are now asking about researchers’ reporting histories in new applications.
International good clinical practice for running clinical trials (ICH GCP) includes reporting results.
Many professional registration bodies include this explicitly in their definition of professional standards, or implicitly through reference to the standards above, which means failure to report is professional malpractice.
Full reporting of results improves medicine and improves research – so it improves lives. People who volunteer for clinical trials trust that the results will contribute to understanding. Researchers who do not report results are choosing to flout the legal, ethical and professional requirements related to their own trials and choosing to damage that trust for all others.
1 “Where a registry is used without a results database available, the results should be posted on a free-to-
access, publicly available, searchable institutional website of the Regulatory Sponsor, Funder or Principal