ABSTRACT
BACKGROUND: In 2009, the Safety Planning, Evaluation and Reporting Team gave detailed recommendations for a well-planned and systematic approach for safety data collection and analysis. Important aspects of this approach included regular reviews of aggregate data by a multidisciplinary team focusing on safety. PURPOSE: This article provides information to facilitate the planning and implementation of aggregate data reviews. METHODS: Our recommendations are based on experience of the authors and review of relevant literature. RESULTS: We present information regarding the planning of aggregate data reviews as well as examples of data displays that are useful for many different compounds. A subset of these data displays could form a set of 'core' analyses to be generated for aggregate data reviews.
Subject(s)
Clinical Trials Data Monitoring Committees/organization & administration , Clinical Trials as Topic/methods , Safety Management/organization & administration , Data Collection/methods , Drug-Related Side Effects and Adverse Reactions/prevention & control , HumansABSTRACT
BACKGROUND: The Safety Planning, Evaluation and Reporting Team (SPERT) was formed in 2006 by the Pharmaceutical Research and Manufacturers of America. PURPOSE: SPERT's goal was to propose a pharmaceutical industry standard for safety planning, data collection, evaluation, and reporting, beginning with planning first-in-human studies and continuing through the planning of the post-product-approval period. METHODS: SPERT's recommendations are based on our review of relevant literature and on consensus reached in our discussions. RESULTS: An important recommendation is that sponsors create a Program Safety Analysis Plan early in development. We also give recommendations for the planning of repeated, cumulative meta-analyses of the safety data obtained from the studies conducted within the development program. These include clear definitions of adverse events of special interest and standardization of many aspects of data collection and study design. We describe a 3-tier system for signal detection and analysis of adverse events and highlight proposals for reducing "false positive" safety findings. We recommend that sponsors review the aggregated safety data on a regular and ongoing basis throughout the development program, rather than waiting until the time of submission. LIMITATIONS: We recognize that there may be other valid approaches. CONCLUSIONS: The proactive approach we advocate has the potential to benefit patients and health care providers by providing more comprehensive safety information at the time of new product marketing and beyond.
