EMA officials lay out need for ‘large, decision-relevant’ COVID-19 trials

Regulatory NewsRegulatory News | 15 May 2020 |  By 

Top officials from the European Medicines Agency (EMA) say that international coordination is needed to ensure that clinical trials for treatments and vaccines for coronavirus disease (COVID-19) are conducted in a way that yields actionable and conclusive results.
“Although the scientific community has responded to the COVID-19 challenge in an unprecedented manner, there are concerns about the growing number of COVID-19 stand-alone clinical trials with a small number of participants and observational studies, which might not generate data required for regulatory decision-making,” EMA says.
In a paper published in Clinical Pharmacology & Therapeutics, EMA Executive Director Guido Rasi, Senior Medical Officer Hans-Georg Eichler and vaccines head Marco Cavaleri and other top agency officials warn that the large number of “stand-alone and observational trials of single-agent interventions” that have popped up in the absence of stronger coordination may impede the effort to identify successful candidates.
The officials argue that negative trial results are not the worst outcome, as they can weed out ineffective treatments, but instead that trials that do not provide useful information about an intervention “leave us as much in the dark as we were before the trial was conducted.”
To demonstrate their point, the officials point to two recent trials, an observational study involving the compassionate use of remdesivir and a small randomized controlled trial of lopinavir plus ritonavir, both of which concluded that additional studies are needed to confirm any benefit.
“For every week that trials don’t deliver, more and more patients are exposed to the wrong treatments, which well-designed and rapidly run clinical trials could have taken off the table, making space to pursue other, and ultimately more meaningful, therapeutic options,” the officials write.
The officials also worry that studies run amid decreasing cases of COVID-19 in some regions may struggle to meet pre-defined enrollment goals, citing the challenges faced during the recent Zika and Ebola virus outbreaks.
Instead, the officials say the best approach would be to feed candidates from well-designed placebo-controlled Phase 2 trials into platform trials that take into account the changing historical controls expected during the pandemic as disease management improves.
Going forward, the officials call on researchers and drugmakers to consider whether their studies or development plans could be incorporated into a platform trial.
The officials also ask ethics committees to weigh whether stand-alone trials meet the ethical standard for research involving human subjects that the “importance of the objective outweighs the risks and burdens to the research subjects.”
“Is this condition met by a small, (underpowered) stand-alone trial, perhaps with a high probability of failure due to lack of enrolment? Or could the objective be better met by redirecting energy to one of the larger ongoing trials?” the officials ask.
EMA, Clinical Pharmacology & Therapeutics


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy