A Perspective on Characterizing Benefits and Risks Derived from Clinical Trials: Can We Do More?
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A Perspective on Characterizing Benefits and Risks Derived From Clinical Trials: Can We Do More?
Robrrt 1. O'NriIl, PhD Center for Drun ., Evaluation and Research. FDA
Kry Words Benefit; Risk; Metrics: Study design; Follow-up; Withdrawals; Clinical trial Corrrspondrncr Addrrss Robert T. O'Neill. PhD, Center for Drug Evaluation and Research, Bldg. 21, 10903 New Hampshire Ave., Silver Spring, MD. 20993-0002 (email: ROBERT.ONEILL@fda .hhs.gov). The views expressed in this article d o not necessarily represent those ofthe US Food and Drug Administration.
h i s article considers a variety of issues associated with the rde that clinical trials p l q in the evaluation of the benefits and risks (harms) of new thempies and with the communication of quantitatively assessed benejh and risks based upon the evidence derived )inm clinical trials. h e article is organized into several sedions that explore and discuss aspects of the challenging area of chamcterizing benefits and risks f i m clinical trials. We begin with a background on the interest in the topic, and then consider a
BACKGROUND The discussion of benefit and risk is a very visible topic within the public, regulatory, and scientific communities. For example, the Institute of Medicine's Committee on the Assessment of the US Drug Safety System held a workshop in January 2006 titled Advancing the Methods and Application of Risk-Benefit Assessment of Medicines (1).The purpose of that workshop, in part, was to identify methodological approaches for performing integrated and explicit assessments of risk and benefit of pharmaceuticals throughout a product's life cycle, including identifying the type of information that would be most useful to decision makers and to identify opportunities and barriers in advancing a public health approach to balancing risks and benefits of pharmaceuticals for drug regulation and risk management. In order to assess benefits and risks associated with therapies, the argument can be made that it is necessary to give equal attention to assessment of risks (harms) and to benefits. Therefore, the recent increased public attention to quantifying safety of drugs is relevant to our consideration of benefits and risks. The Institute of Medicine published a report, The Future of Drug Safety, containing far-reaching recommenda-
theme that arguesfor the imbalance or asymmetry in the way benefits and risks in clinical trials are currently chmctcrized, using examples from the medical litemture to illustmte the points. We then comment on several topics, such as mctn'cs for benejit:risk that are invdved in other aspects of benejit:risk analysis, which relate to other mtides in this issue. Einallu, we make some concluding remarks on how to make progress in the f.ture to improve benefit:risk analysis in clinical trials.
tions that potentially will impact benefit and risk assessment (2-4). As further evidence that risks (harms) of new therapies are receiving increased attention, medical journal editors have recognized the need for enhancing the report
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