BIO Comments on Promoting the Use of Complex Innovative Designs in Clinical Trials
BIO submitted comments on the Food and Drug Administration’s (FDA) public meeting on Promoting the Use of Complex Innovative Designs in Clinical Trials.
BIO supports the development and launch of this initiative. BIO shares the FDA’s goals for the pilot program to promote public learning about Innovative Clinical Trial Design (ICTD) and to demonstrate the use of novel designs to increase the efficiency and/or feasibility of clinical development. The pilot program will present multiple opportunities for public learning and the advancement of ICTD.
To advance the successful implementation of the ICTD Pilot Program, BIO developed recommendations on the timelines, communication, and disclosure of information, among other issues. BIO’s comments also include high-level case studies of innovative clinical trial designs which have historically shown low levels of regulatory, in an effort to provide insight into the general types of innovative clinical trial designs BIO would like to see in the pilot program.