Will we ever see the full evidence on Covid-19 drugs?
A coalition of health groups has called on the European Medicines Agency to make public the full evidence on Covid-19 drugs as rapidly as possible.
In an open letter published today, four national Cochrane groups and IQWIG call for the publication of the Clinical Study Reports for all COVID-19 medicines and vaccines on the day a European marketing authorisation is issued.
UPDATE: On 28 May, EMA responded to the letter. While non-committal, the response indicated that EMA views the proposal favourably and is reviewing it.
Clinical Study Reports (CSRs) are lengthy and highly detailed documents providing information on the outcomes of clinical trials that cannot be found elsewhere.
Pharmaceutical companies have to submit CSRs to regulators in order to prove that their drugs are safe and effective, but most regulators - including the U.S. Food and Drug Administration - refuse to make them public.
The European Medicines Agency is a positive exception to this rule (as is Health Canada), but it currently only makes CSRs public with a time delay of 60 days.
In their letter, Cochrane and IQWIG argue that:
"Because of the severity of the current situation, regulators are aiming to accelerate the marketing authorisation process... This acceleration effort is understandable and to be welcomed in this exceptional situation. To achieve sustainable effects in health care, this effort must also include the publication of CSRs to make the full information on any new medicine or vaccine publicly available as soon as possible.
"We therefore call for the publication of all CSRs on all COVID-19 medicines and vaccines on the day of marketing authorisation.
"To assess these products further and to accelerate the development of additional products, the fast and full public availability of the information submitted to regulators is of utmost importance. Transparency is also vital to maintain public trust during the crisis. With its established processes, EMA is in a unique position to make a difference in the worldwide fight against the pandemic."
TranspariMED has repeatedly advocated for better access to Clinical Study Reports, and fully supports today's call by Cochrane and IQWIG.