Regulatory Focus™ > News Articles > 2020 > 4 > Regulators urge RCTs with control arms for COVID-19 drug trials

Regulators urge RCTs with control arms for COVID-19 drug trials

Posted 09 April 2020 | By Zachary Brennan 

Regulators urge RCTs with control arms for COVID-19 drug trials

As no specific therapeutic has clearly demonstrated efficacy for treating COVID-19, more than two dozen pharmaceutical regulators around the world agreed in a virtual workshop last week that randomized controlled trials (RCTs), long considered the gold standard for clinical trials, will be necessary for approvals.

The summary report of the meeting also stressed the need for COVID-19 drug developers to include an appropriate control arm (“i.e. not including antivirals or immune modulators”), and to ensure that the RCTs are “appropriately designed to generate data that meet regulatory requirements for approval, could lead to timely regulatory decisions.”

Under the umbrella of International Coalition of Medicines Regulatory Authorities (ICMRA) and co-chaired by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency, the regulators also said that small studies or compassionate use programs are unlikely to be able to generate enough evidence “to allow clear-cut recommendations.”

But they also said that compassionate use programs are beneficial to public health during the pandemic and should be allowed as long as they do not hamper recruitment in clinical trials. Regulators also agreed to exchange information on trials.

“Regulators expressed concern due to the multitude of ongoing trials and access programmes, which may lead to shortages of investigational products, and recommended this to be carefully monitored. It was acknowledged that preservation of access to medicines approved in indications other than COVID-19 and used as well in COVID-19 investigations might be critical in these situations, posing ethical issues of equitable distribution,” the report adds.

Among the therapeutics discussed, ICMRA points to remdesivir, lopinavir/ritonavir with or without interferon–𝛽 and chloroquine/hydroxychloroquine, as well as antivirals, including monoclonal antibodies and hyperimmune sera, and immunomodulating agents such as IL-6 and IL-1 inhibitors.

ICMRA previously held a meeting in March to discuss vaccine development to combat the coronavirus and another meeting this week on observational studies and real-world data.

ICMRA Summary Report


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.