Report | May 2022 | Download PDF
The report COVID-19 Clinical Trial Integrity: Impacts on global health and the future European Regulatory Agenda reviews the integrity of clinical trials for COVID-19 vaccines, repurposed drugs and non-pharmaceutical interventions, discusses the factors driving research successes and failures and their impacts on global health, and explores the implications for future European and global regulatory agendas.
COVID-19 vaccine trials run in Europe and North America were generally well designed and transparent, and supported by effective regulation. However, there are strong indications that the trials of some vaccines now being exported from emerging production hubs had transparency shortcomings.
COVID-19 drug trials largely ended up as research waste due to lack of coordination and weak research designs. Lack of regulatory intervention and the weak global clinical trial registry infrastructure contributed to the problem.
Trials of non-pharmaceutical interventions were rarely conducted, leaving large evidence gaps that may undermine responses to future epidemics and pandemics.
Recommendations for the European Medicines Agency
- Designate a gatekeeper to prevent futile trials of investigative medicinal products from being launched.
- Initiate a global dialogue on common minimum transparency standards both for regulatory documents and for pivotal clinical trial data.
- Exchange experiences with other regulators on promoting and enforcing clinical trial registration and reporting.
- Set a date for the resumption of releasing Clinical Study Reports.
Recommendations for the European Commission
- Set up a working group on improving the coordination and design of non-drug trials.
- Set up a working group on improving the evidence base for non-pharmaceutical interventions.
- Commit the HorizonEurope research programme to World Health Organization best practices in clinical trial registration and reporting.
- Urge the Heads of Medicines Agencies and governments of Member States to encourage and enforce the reporting of drug trial results.
- Adapt the EUDAMED database to require the registration and reporting of medical device trials.
Download COVID-19 Clinical Trial Integrity: Impacts on global health and the future European Regulatory Agenda here (PDF).