Modern Methods of Clinical Investigation (1990) / Chapter Skim
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1. Medical Technology Development: An Introduction to the Innovation-Evaluation Nexus
1. Medical Technology Development: An Introduction to the Innovation-Evaluation Nexus
Pages 1-15
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From page 1... ...
More specifically, medical technology development can be defined as a multi-stage process through which a new biological or chemical agent, prototype medical device, or clinical procedure is technically modified and clinically evaluated until it is considered ready for general use. Although this definition suggests an organized and systematic process, much developmental activity actually occurs in a non-orderly fashion in everyday clinical practice.
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This first volume of the Institute of Medicine (IOM) Committee on Technological Innovation in Medicine focuses on the interplay between strategies for clinical evaluation and the development of new drugs, devices, and clinical procedures.
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A different issue is concern about the adequacy of the evidence underlying development and dissemination of clinical procedures into health care (2~. For example, extracranial-intracranial vascular bypass surgery for stroke was first tried in human beings in 1967; the procedure underwent rapid diffusion during the 1970s, but was only recently reported ineffective in preventing cerebral ischemia in patients with atherosclerotic disease of the carotid and middle cerebral arteries (3~.
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In view of these considerations, it seemed timely to publish a volume of papers analyzing the validity of these modern methods of clinical investigation and asking if and how their systematic application could improve the technology development process. Before addressing some of the points made by the various authors, a more complete picture is needed of current shortcomings in the clinical evaluation of new medical technologies.
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In the United Kingdom, Inman established the Prescription-Event Monitoring Scheme, which tracks the performance of all new chemical entities in clinical practice, to speed the early detection and analysis of adverse events (see Chapter 6~. Such monitoring also can facilitate the earlier detection and analysis of benefits; following their introduction into practice, beta-blockers were found to be of potential value in a wide variety of cardiac and non-cardiac conditions.
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It is only with the introduction of Mason Sones's arteriography in 1958 that the success of surgery in terms of graft patency could be validated objectively, and rational patient selection criteria established. Rene Favaloro at the Cleveland Clinic is generally credited with the first report on coronary artery bypass surgery using a saphenous vein graft in 1968 (12~.
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In addition to such changes in patient indications, surgical techniques have also undergone further development. For example, internal mammary arteries have recently been found to have a much higher long-term patency rate than saphenous vein grafts (201.
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Despite these data, however, there is still no conclusive evidence on the comparative efficacy and safety of PTCA versus medical treatment in single vessel disease, and of PTCA versus CABG in multivessel disease. Randomized controlled clinical trials are clearly overdue.
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Evaluative strategies, however, have rarely attempted to provide information on the effectiveness and long-term safety of technologies as they evolve in normal, uncontrolled, daily medical life. In addition, the angina pectoris example reveals a remarkable asymmetry in the existing strategies for providing safety and efficacy information: drugs undergo rigorous clinical testing before their introduction into general use, clinical procedures are still assessed mainly in an ad hoc fashion, and evaluations of new medical devices are somewhere in between.
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Because many therapeutic agents for today's chronic degenerative diseases treat only symptoms, improvements in functional status, health status, and quality of life are increasingly important endpoints in clinical evaluation. However, Marilyn Bergner in this volume asserts that the inclusion of health status or quality of life considerations in clinical trials is often an afterthought.
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As mentioned, the RCT is generally regarded as the statistically most powerful method for determining pharmaceutical efficacy in pre-marketing evaluations. During the development of devices and clinical procedures, some real conceptual, practical, and ethical difficulties may exist regarding the use of RCTs, and efficacy evaluation will need to depend on other adequately controlled study designs.
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Leslie and Noralou Roos, Fisher, and Bubolz describe the strengths and weaknesses of health insurance data bases, and discuss how combining administrative and clinical data bases could compensate for some weaknesses. The discussion of the benign prostatic hyperplasia assessment, which compares different surgical techniques and watchful waiting, exemplifies the complementary role of observational methods and experimental methods during the development process.
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Policy Mechanisms for Improving Developmental Decision Making In the aggregate, this volume reflects on the evaluative shortcomings in the present-day development of drugs, devices, and clinical procedures and argues for a more balanced assessment strategy that provides comparable information on the relevant outcomes for all technologies. Recent advances in the art and science of clinical evaluation open up new opportunities for providing this evidence.
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In conclusion, a more rational and efficient development stage in the innovation process will require stronger and new kinds of alliances in evaluative research among the venous participants: those who develop new technologies; those who improve and apply the science and tools of evaluation; and those who use the resulting information for regulatory approval, reimbursement, or clinical decisions. It will also require a willingness to explore and debate the often complementary value of various evaluative methods for improving developmental decision making.
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From page 15... ...
Long-term results of prospective randomized study of coronary artery bypass surgery in stable angina pectoris. Lancet 1982; 2:1173-1180.
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