Analysis of integrated clinical trial protocols in early phases of medicinal product development.

ABSTRACT:

Purpose

While in the past, most clinical trial applications (CTAs) following non-integrated (standard) protocols were used to investigate one primary objective concerning a (new) drug, nowadays, the use of integrated protocols investigating multiple objectives within the same CTA becomes more and more popular. The aims of the present study were to investigate the usage and the impact of integrated protocols on regulatory activities and to find the motivation for their increasing use.

Methods

Two thousand nine hundred sixty-nine phase I and I/II CTAs submitted to the German Federal Institute for Drugs and Medical Devices (BfArM) during the time period from August 1, 2004, until August 31, 2014, were analysed with regard to protocol and sponsor status, duration until initial a

SUBMITTER: Fruhner K 

PROVIDER: S-EPMC5684304 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature