Risk Management In Clinical Research: Process Development And Application

By Emily Haglund, IMARC Research, Inc.

Recently, two key pieces of guidance were released from Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding risk based approaches to clinical research. These documents include FDA’s “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” and EMA’s “Reflection paper on risk based quality management in clinical trials”. The focus of the regulators on this concept initiates a discussion of how to introduce, implement, and apply risk management principles to clinical trials. The applicable guidances for good clinical practice (GCP), ICH E6 and ISO14155, state explicitly that the sponsor is responsible for quality assurance and quality control. One aspect of quality involves how risks are approached and managed throughout the course of a clinical trial.

FDA released a final guidance document in August 2013 titled “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring”. This final guidance document focused on the implementation of risk based strategies for monitoring within the clinical research field. It explored different monitoring methods and techniques, identification of critical data and processes to be monitored, monitoring plan considerations, and documentation of monitoring activities. In addition, the last section of the guidance includes a chapter titled “Additional Strategies to Ensure Quality.” This section focused on other aspects of clinical trial management that if implemented could facilitate greater study quality. The guidance states: “FDA considers monitoring to be just one component of a multi-factor approach to ensuring the quality of clinical investigations.” Specific focus areas are protocol and case report form design, clinical investigator training and communication, delegation of monitoring responsibilities to a CRO, and clinical investigator site selection and initiation. While these four aspects are briefly discussed and associated to monitoring a clinical trial, a significant impact to clinical research success can be realized when risk based approaches are applied to all clinical research activities.

EMA released a paper in November 2013 titled “Reflection paper on risk based quality management in clinical trials”. The document describes how GCP requirements can become integrated with quality concepts through every aspect of the trial and to encourage and facilitate this integration for a more systematic, prioritized, risk-based approach to the management of clinical trials. The reflection paper describes specific areas of risk within the current clinical research field.