Inadequate Dissemination of Phase I Trials:

Inadequate Dissemination of Phase I Trials: A Retrospective Cohort Study

Evelyne Decullier^1,2,3,4, An-Wen Chan⁵, François Chapuis^1,2,4,6*

1 Hospices Civils de Lyon, Pôle Information Médicale et Evaluation en Recherche, Lyon, France, 2 Université de Lyon, Laboratoire Santé Individu Société (EA SIS), Lyon, France, 3 Université Lyon 1, Lyon, France, 4 Comité de Protection des Personnes, CPP Sud-Est III, Lyon, France, 5 Mayo Clinic, Rochester, Minnesota, United States, 6 Université Lyon 1, Réseau d'Épidémiologie Clinique International Francophone (RECIF), Lyon, France

Background

Drug development is ideally a logical sequence in which information from small early studies (Phase I) is subsequently used to inform and plan larger, more definitive studies (Phases II–IV). Phase I trials are unique because they generally provide the first evaluation of new drugs in humans. The conduct and dissemination of Phase I trials have not previously been empirically evaluated. Our objective was to describe the initiation, completion, and publication of Phase I trials in comparison with Phase II–IV trials./.../