By Gerardo Fortuna
The EU’s preparedness for outbreaks of infectious disease has increased, but member states still need to overcome ethical, administrative, regulatory and logistic bottlenecks for boosting clinical research, medical experts said at a scientific meeting in Brussels.
[...]
The main idea to emerge from the meeting was that integrating clinical research and having a good data sharing practice can contribute to an efficient and effective response in a public health emergency.
[...]
[Professor Herman Goossens] said that conducting clinical trials in Europe was “a nightmare for industry and academic investigators”. The reason, he said, was different approaches and different views on clinical research protocols of the national competent authorities (NCAs) and research ethics committees (RECs).
Both bodies support the need for clinical research in an infectious disease outbreak and for swift review. However, the availability of expedited review varies across member states, and there is a lack of clarity regarding the standard operating procedures for such a review, a study conducted in the framework of PREPARE found.
The study also showed that NCAs and RECs are not uniformly ready to expedite the review of clinical research in a public health emergency.
[...]