BMJ paper calls for more regulatory coordination in the Americas to improve clinical trial transparency | Tech Blog
A new paper published in the BMJ by co-authors Trudo Lemmens and Carlos Herrera Vacaflor calls for more coordination between regulatory agencies in the Americas despite recent initiatives designed to improve health data transparency in clinical trials.
In the paper, Lemmens and Vacaflor argue that government health agencies involved in health-related research should both coordinate and streamline their research ethics committee governance as well as their transparency requirements across different regulatory regimes. The authors say agencies that are members of the Pan American Health Organization should adopt the approach the European Medicines Agency has taken regarding clinical data used in making regulatory decisions in that the data doesn’t constitute commercially confidential information, and the burden of proof should be placed on drug companies as to why specific data should remain confidential. Additionally, they call for research ethics committees to coordinate the promotion of transparency standards.
While some countries in the Americas have “taken important steps” to establish transparency standards and some have made progress in enacting mandatory clinical trial registration and data transparency, “some leading countries still fail even to impose registration with a publicly accessible registry.”
The paper said that if some countries in the region “were to streamline the different overlapping regulatory fields that govern clinical trials data and follow the EMA’s lead in creating a presumption that data should be publicly accessible, they would take an important step towards the implementation of comprehensive data transparency.”
The authors believe that in order to achieve a coherent transparency of health data in the Americas, countries need to better manage the applicable rules, guidelines and governance tools they have.
“This means different regulatory agencies and funding agencies coordinating applicable transparency rules at each national level,” they said. “The further development of publicly accountable REC systems, directly accountable to the state, must be part of promoting meaningful transparency.”