Evaluation of Clinical Trials in Onco-haematology: A New Method Based on Risk Analysis and Multidisciplinarity.

Date publication

mai 2021

Journal

Therapeutic innovation & regulatory science

Auteurs

Membres identifiés du Cancéropôle Est :
Dr BOUDALI Lotfi

Tous les auteurs :
Lapière J, Christen C, Kerouani-Lafaye G, Monard A, Turcry F, Grude F, Gazin V, Burbank M, Chocarne P, Taleb A, Belgodere L, Brunel L, Chu C, Deligny C, Ake E, Gonçalves S, Bouheret P, Barbou-des-Courières S, Sainte-Marie I, Guyader G, Boudali L, Albin N

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/33502745

Résumé

European member states are increasingly vying with one another to recruit patients for clinical trials (CTs). The French national agency for medicines (ANSM) now receives an ever-growing number of CTs, extending response times. The aim of the new methodology presented herein is to reduce assessment times below the national mandatory timeframe of 60 days and to improve patient safety.

Mots clés

Clinical trials, Criticality, Grounds for non-acceptance, Multidisciplinarity, Onco-haematology, Timeframes

Référence

Ther Innov Regul Sci. 2021 05;55(3):601-611