TrialAssure Academic Pricing (TAP) provides the company’s clinical trial registration and disclosure reporting application at a discounted price. The offering enables sponsors and academic researchers to manage the disclosure process, including registry assessments, validation and quality checks, review cycles, approvals, as well as comments from regulatory authorities.
“In an academic setting, it can be more difficult to obtain public-ready information from investigators and other contributors to the study. When a study completes, the primary focus is on analyzing results and getting published, with transparency obligations often taking a back seat,” Zach Weingarden, product solutions manager, TrialAssure, told us.
Between pharmaceutical companies and universities, Weingarden said the penalties are viewed differently.
He explained, “For pharma companies, there is the potential of fines of up to $10,000/day and the general poor stigma of being non-compliant or not transparent is bad for the company’s image. While that is also true for universities, the bigger issue is that most leading scientific journals require clinical trial disclosures be up-to-date or they will refuse to publish any of the results.”
Additionally, the National Institutes of Health (NIH) can withhold funding for other studies.
“These two areas are much more impactful for continued funding and research at the academic level, so it is crucial for universities to get it right,” added Weingarden.
Only 11% of universities post clinical trial results to the European Clinical Trial Register (EUCTR) within the required timeframe, according to a report published in The BMJ.
Clamping down on compliance, the Chair of the Science and Technology Select Committee, Norman Lamb MP, recently wrote to more than forty UK universities. The committee plans to question institutions later this year following a debrief with AllTrials, which will be monitoring compliance.
In the US, a study in BMC Medicine found that approximately 35% of universities have a policy addressing clinical trial results reporting and 74% do not have electronic transparency system to manage reporting.
