PARIS In Europe, patient involvement in drug development and regulatory assessment is evolving from an ad hoc occurrence into a more structured process, driven by a shared interest on the part of regulators and drug developers in having patient input influence the development and assessment process.
Some patients and their advocates are pushing for this too, as was evident during a session on the topic at the DIA Euromeeting here Wednesday. One patient representative challenged an EMA official on when the agency's Committee for Human Medicinal Products (CHMP) would recruit one or more patients. The response was not encouraging. "The composition of the CHMP is defined by legislation, so that's not going to happen easily," replied Francesco Pignatti, the EMA's head of oncology, hematology and diagnostics.
Nevertheless, patient involvement in the EMA's activities is a work in progress, he told delegates. It has followed a