On March 17, 2016 the National Institutes of Health (NIH) together with the Food and Drug Administration (FDA) released for public comment a draft clinical trial protocol template for phase 2 and 3 Investigational New Drug application (IND) / Investigational Device Exemption (IDE) studies. Comments are being accepted until April 17, 2016. The goal of this effort is to allow investigators to more easily prepare protocols that are consistently organized with all the necessary information for review. The agencies welcome and encourage feedback from those involved in the clinical trial enterprise, including investigators, sponsors, members of institutional review boards, and other stakeholders, to help create a robust template for use with future protocols.

Efforts such as this template help to ensure consistency while streamlining protocol development and meeting regulatory requirements. CTTI is a proponent of an efficient, quality-driven, streamlined approach to the design, development, and conduct of clinical trials. Providing materials and resources to facilitate trial design and development is aligned with the CTTI Quality by Design (QbD) approach, and such tools can be easily integrated into clinical trial development plans. CTTI supports and applauds the NIH and FDA for their initiative and encourages similar work.

The draft template released by the NIH and FDA is available here. CTTI recommendations on how QbD principles can be applied to improve the quality and efficiency of clinical trials can be found here.