EMA Urged to Publish Full Trial Data After Authorizing COVID-19 Therapies
European industry leaders would like clinical study reports (CSR) on COVID-19 trials to be available on the same day a new treatment is authorized for use, according to a letter to the European Medicines Agency (EMA).
Several international directors from independent watchdog group Cochrane joined the heads of drug assessment from Germany’s Institute for Quality and Efficiency in Health Care (IQWIG) in urging the EMA to reinstitute the data publication policy it suspended last year. That policy was suspended due to moving agency headquarters to Amsterdam in the wake of Brexit.
The letter emphasizes that information gleaned from CSRs are the only data that offer sufficient confidence in the safety and efficacy of new COVID-19 vaccines and medicines.
The EMA has responded that the agency is exploring a possible phased reintroduction of the suspended policy that would give priority to the publication of clinical data related to COVID-19.
To read the letter, click here: https://bit.ly/36G13wU.