Journal
THERAPIE
Volume 77, Issue 1, Pages 49-57Publisher
ELSEVIER
DOI: 10.1016/j.therap.2021.11.010
Keywords
COVID-19, Clinical research, Medicine, Regulation, Data sharing
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The COVID-19 pandemic has sparked an unprecedented academic and industrial research effort, leading to adjustments in regulatory procedures and removal of certain obstacles in clinical research organization, ultimately accelerating the conduct of trials.
The pandemic of coronavirus disease-19 (COVID-19) has led to the deployment of an unprecedented academic and industrial research effort whose sometimes redundant character as well as the lack of both national and international steering can be regretted. However, it must be noted that during this crisis, regulatory procedures were adapted and certain obstacles in the organization of clinical research were partly removed to contribute to the deployment of trials as close as possible to patients and to facilitate monitoring and control procedures. The digitization of certain processes and the decentralization of certain activities have been implemented under the cover of a mobilization of the authorities and all the institutional, academic and industrial players. While in the UK, the optimization of resources through a single platform trial has made it possible to demonstrate or refute the efficacy of many treatments, in France the health crisis has highlighted the fragility of the organization of clinical research, in particular a lack of coordination and funding, difficulties in implementing studies and a certain reluctance to share data. However, the crisis has also revealed the capacity of the different actors to adapt and has allowed the improvement of several processes useful for the deployment of therapeutic innovation. Let us hope that the lessons learned during this crisis will allow for greater efficiency in the event of a new pandemic and, above all, that the progress made will continue to apply to all future clinical research activities.
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