Universities and clinical trials: Common myths debunked
TranspariMED's recent study showed that many UK universities do not understand their obligations related to registering and reporting clinical trials. High time to debunk some common myths and misunderstandings.
IMPORTANT UPDATE, APRIL 2018:
Following further communications with UK universities and feedback from European UAEM activists, two more common myths need debunking:
MYTH +1: If summary results are posted onto trial registries within 12 months as required by WHO guidelines, this could prevent researchers from publishing trial outcomes in an academic journal.
Fact: The International Committee of Medical Journal Editors (ICMJE) has explicitly stated that summary results posted onto trial registries will not be considered to be prior publication. Thus, medical journal editors will not refuse to publish journal articles reporting trial outcomes on that basis.
MYTH +2: As Clinicaltrials.gov is a U.S. government registry, European and UK universities are not bound by the disclosure laws governing that registry.
Fact A: Universities should aim for compliance with global best practices, not just narrow legal compliance. WHO guidelines clearly state that summary results have to be posted on every registry where a trial has been registered within 12 months of trial completion, whether national laws require this or not. Sharing trial results is (always) an ethical and scientific responsibility, not just (sometimes) a legal one.
Fact B: The relevant U.S. transparency law (FDAAA) also covers some clinical trials sponsored by universities outside the United States. (See here for an example of a UK university breaking U.S. law.) This means that European universities too are subject to the $10,000-per-day fine set out by FDAAA.
Fact C: Determining whether or not a clinical trial is subject to FDAAA is very difficult, and requires an in-depth understanding of FDAAA and its Final Rule, documents hundreds of pages long. And the U.S. is just one of around 70 countries worldwide with regulations governing clinical trial disclosure. It is much easier for universities to do the right thing and ensure that all trials they sponsor post their summary results than to do a case-by-case legal analysis of every single trial.
Note that in the United States, FDAAA does not mandate the registration of Phase 1 trials. However, all NIH-funded phase 1 trials now must be registered. (Thank you to Alexey Bersenev and Erick Turner for highlighting this.)
Regulators and trial registries could do more to clarify expectations and reduce confusion.
Many of their websites tend to be overly complex and written in crypto-bureaucratese, making it hard for universities and researchers to understand the rules they are expected to follow.
When some trial registries send out notifications asking for registry entries to be updated, they email them to the principal investigator of a trial, but not to the institution sponsoring it. This may create the misleading impression that universities are not responsible for regularly updating registry entries and posting summary results.
In many instances, different laws, rules, regulations, standards and processes make two different parties - individual researchers and trial sponsors - responsible for doing the same things. Such overlapping obligations may lead universities to believe that their responsibility ends where that of their staff begins, which is incorrect. Just because Law A specifies that individuals have to do something, Law B on institutional responsibilities for doing the same does not cease to apply. Regulators and trial registries could do more to clarify this.
Can you think of any other common myths? If yes, please get in touch so we can update this blog.