Risk-Based Monitoring: BIO Comments on Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

 

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.” 

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.  BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment. 

BIO supports the goals of the guidance to assist sponsors of clinical investigations in developing risk-based monitoring strategies and to enhance human subject protection and the quality of clinical trial data.  Biotechnology companies are at the forefront of biomedical innovation and welcome proposed strategies for monitoring activities that will assist them in conducting clinical investigations in a more modern, risk-based manner. 

As an active member of the Clinical Trials Transformation Initiative (CTTI), BIO commends the work that the Agency and CTTI have done to survey current monitoring practices while compiling recommendations.  BIO looks forward to continuing to articulate and build support for these concepts through CTTI and among clinical trial stakeholders, including industry, contract research organizations, academia, and regulators. 

Approaches such as centralized clinical trial monitoring and a focus on the most critical data elements can help Sponsors and FDA to deploy resources to the areas that will best promote the integrity and quality of clinical trial data.  Conceptually, the approaches detailed in the guidance should enhance the efficiency and effectiveness of clinical trial monitoring, but great care should be taken in implementation of these approaches to reduce the potential for duplicative or burdensome monitoring requirements.

BIO appreciates this opportunity to comment on the “Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.”  Specific, detailed comments are included in the following chart.  We would be pleased to provide further input or clarification of our comments, as needed.