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.
Lacombe, D., Golfinopoulos, V., Negrouk, A., & Tombal, B. (2020). Clinical research in Europe: Who do we do all that for? Journal of Cancer Policy, 23, 100217 [1-3]. https://doi.org/10.1016/j.jcpo.2020.100217 (Original work published 2020)