Fiche publication
Date publication
janvier 2023
Journal
Annals of oncology : official journal of the European Society for Medical Oncology
Auteurs
Membres identifiés du Cancéropôle Est :
Dr AMARAL Teresa Maria
Tous les auteurs :
Perez-Gracia JL, Penel N, Calvo E, Awada A, Arkenau HT, Amaral T, Grünwald V, Sanmamed MF, Castelo-Branco L, Bodoky G, Lolkema MP, Di Nicola M, Casali P, Giuliani R, Pentheroudakis G
Lien Pubmed
Résumé
During recent years, the burden of bureaucracy in clinical research has increased dramatically, adversely impacting the activity of investigators and clinical research teams. Although compliance with the Declaration of Helsinki, the guidelines for Good Clinical Practice (GCP), and other applicable regulations remains unquestionable, their overinterpretation and substitution by the internal operating procedures of sponsors and Contract Research Organizations (CROs) have increased the administrative burden. A survey conducted by the European Society for Medical Oncology (ESMO) Clinical Research Observatory (ECRO) among 940 investigators confirmed that they considered that the administrative burden in clinical research is excessive; that administrative procedures could be reduced without affecting the safety and the rights of the patients and the quality of the data; and that bureaucracy represents an obstacle for clinical research.
Mots clés
Declaration of Helsinki, Good Clinical Practice, clinical trial monitoring, clinical trial sponsoring, clinical trials
Référence
Ann Oncol. 2023 01;34(1):70-77
