Clinical research in Europe: Who do we do all that for?. (March 2020)

• Record Type: Journal Article
• Authors: Lacombe, Denis; Golfinopoulos, Vassilis; Negrouk, Anastassia; Tombal, Bertrand
• Is Part Of: Journal of cancer policy. Volume 23(2020)
• Publication Date: 2020-03
• Subjects: Clinical research -- Treatment optimization -- European regulations; Cancer -- Government policy -- Periodicals; Cancer -- Patients -- Services for -- Periodicals; Medical Oncology -- Periodicals; Public Health -- Periodicals; Cancer; Periodicals; 362.196994
• DOI: 10.1016/j.jcpo.2020.100217
• Languages: English
• ISSNs: 2213-5383

Abstract

Highlights: Clinical research for optimized treatments faces increased regulatory challenges. Regulatory frameworks should make continued therapeutic progress possible. Patient centricity needs reforms for addressing clinically relevant questions. Future EU regulations need tailoring to medical relevance of research protocols. Abstract: Independent applied clinical research addresses questions which are centered on optimization of treatments and patient management. It often finds itself confronted to policies and regulations implemented more specifically with pharmaceutical research and drug development in mind but which in practice apply throughout all clinical research programs. We report herein a specific case illustrating such challenges. We question how far legal constraints overshoot their initial objectives, leading to opposite effects for which they were set up. In an era where independent evaluation of cancer treatments is becoming so critical due to complexity, duplication and costs, comprehensive and pragmatic reform of our frameworks appears critical.