Larry Kessler

Study design in the evaluation of breast cancer imaging technologies

RATIONALE AND OBJECTIVES Bringing a new imaging technology to market is a complex process. Beyond conceptualization and proof of concept, obtaining U.S. Food and Drug Administration (FDA) approval for clinical use depends on the documented experimental establishment of safety and efficacy. In turn, safety and efficacy are evaluated in the context of the intended use of the technology. The purpose of this study was to examine a conceptual framework for technology development and evaluation, focusing on new breast imaging technologies as a highly visible and current case in point. MATERIALS AND METHODS The FDA views technology development in terms of a preclinical and four clinical phases of assessment. With a concept of research and development as a learning model, this phased-assessment concept of regulatory review against intended use was integrated with a five-level version of a hierarchy-of-efficacy framework for evaluating imaging technologies. Study design and analysis issues are presented in this context, as are approaches to supporting expanded clinical indications and new intended uses after a new technology is marketed. CONCLUSION Breast imaging technologies may be intended for use as replacements for standard-of-care technologies, as adjuncts, or as complementary technologies. Study designs must be appropriate to establish claims of superiority or equivalence to the standard for the intended use. Screening technologies are ultimately judged on their demonstrated effectiveness in decreasing cause-specific mortality through early detection, but they may be brought to market for other uses on the basis of lesser standards of efficacy (eg, sensitivity, specificity, positive and negative predictive value, and stage of disease detected).

Medical device vigilance at FDA.

This overview of medical device vigilance at the U.S. Food and Drug Administration (FDA) discusses the basic reporting regulation and program at FDA. The FDA program has grown to the point where we now receive over 100,000 reports per year. How FDA examines the data patterns in overall reporting, to identify signals in the database, and the potential actions FDA takes to respond to these problems are also presented. New initiatives include, for example, new methods to triage reports and the move developing an internationally harmonised nomenclature.

Clinical study: interventional cardiology: editorial commentArteriotomy closure devices—the FDA perspective∗

In this issue of the Journal , Dangas et al. [(1)][1]assessed the incidence of vascular complications at the Washington Hospital Center following percutaneous coronary interventions (PCI) when arteriotomy closure devices (ACD) were used to achieve hemostasis of the femoral artery versus when manual

Panel discussion of case study 1

Dr Kessler-: The panelists are Joel Greenhouse, from Carnegie Melon, Tony Lachenbruch from the Center of Biologics, Larry Gould from Merck, )avid Cornblath from Hopkins and Russ Katz from Center for Drug Evaluation and Research (CDER). I am hoping they will concentrate on some of the reg,ulatory implications for the Bayesian approach in terms of turning this into real product and real studies. For example, does it better establish safety and effectiveness? What is the added value here? Wlhat are the dangers? How will this play in front of ain advisory panel? And, will a Bayesian approach help with labeling for patients and physicians?