Cochrane supports European regulators as they urge clinical trial sponsors to share their results

Cochrane ’s Editor in Chief supportsan open letter recently co-authored by the European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), reminding clinical trial sponsors of their obligation to make their results public.Cochrane has long recognised that clinical trials are key to improvements in patient care and disease prevention and that access to information from these trials is essential for patients, practitioners, policy makers and other stakeholders to be able to make well-informed decisions about healthcare and medical research. Yet an unacceptable number of sponsors allow their trials to go unreported, despite their legal obligations.Karla Soares-Weiser, Cochrane ’s Editor in Chief, responded to the EC-EMA-HMA letter, saying: “Cochrane strongly supports the reporting of results from all clinical trials. Failure to report findings and the selective sharing of results stop us from getting a full view of the evidence for our systematic reviews – so the be nefits of an intervention could be exaggerated, or the harms underestimated. This severely undermines the ability to make truly evidence-informed decisions about healthcare.We welcome this effort from these key European stakeholders to push trial sponsors to meet their ethical obligations by submitting their protocols and results in a timely manner. While regulations already exist in this area, action needs to be taken to ensure compliance. We urge the sponsors of ...
Source: Cochrane News and Events - Category: Information Technology Authors: Source Type: news