Technological Innovation Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper (1989) / Chapter Skim
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5. Improving the Translation of Research Findings into Clinical Practice: Some Opportunities for Change
5. Improving the Translation of Research Findings into Clinical Practice: Some Opportunities for Change
Pages 40-52
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From page 40... ...
A primary difference concerns the asymmetry of the evaluative strategies employed: drugs have over the last quarter century come to undergo rigorous clinical testing before their introduction into general use, while clinical procedures are still being assessed only in a more ad hoc fashion, and new medical device evaluations are to be found somewhere in between. It might be expected that this asymmetry reflects important differences in the effectiveness and efficiency of the three different processes by which research findings are translated into clinical practice.
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From page 41... ...
. The number of NCEs entering human testing fell from a mean of 89 a year in the period 1950-1962, to 35 a year in 1963-1972, to 17 a year in the period 19751979 (an overall reduction of 81 percent)
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From page 42... ...
However, it is interesting that -- in contrast to the medical device amendments -- there is no legal mandate to encourage development and innovation, but only to assure the marketing of "safe and effective" drugs (85~.
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From page 43... ...
Even apart from life-threatening diseases, there is a general need for such Phase IV information, because the full range of a drug's risks and benefits wall emerge only when it is used in actual circumstances of clinical practice. Drugs, once marketed, are subject to empirical innovation -- just like devices or clinical procedures.
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From page 44... ...
60 Furthermore hospital formularies favor the lowest cost products and the Maximum Allowable Cost Program reimburses Medicare patients only for the lowest cost product. In addition international competition from Japan and Europe has increased (recently the EEC introduced the protection of the exclusive rights of the company that submits a file for regulatory approval.
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From page 45... ...
........................... 0 Source: Economist, February 1989 The Developmentof Medical Devices Moving from the pharmaceutical to the medical device industry, the latter is younger, more nationally oriented, and characterized by smaller firms; the image of the innovative engineer developing a device prototype in his basement, garage, or study still has some relevance, although it may become a metaphor in the 199Os.
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From page 46... ...
. In view of the technically evolving nature of the device and the fact that investigators usually must be educated and trained in the public health and safety and with ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose" (520, Aim 62 TDEs are devices under development which require FDA approval to initiate clinical evaluation in humans.
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From page 47... ...
When comparing the effectiveness and efficiency of device development to drug development and considering the welI-known methodological weaknesses of traditional observational methods, it is timely to assess the strengths and weaknesses of new non-experimental methods for providing reliable information about the health effects of new medical devices. In the quest for improved and more reliable methods of clinical device evaluation, however, it is necessary to consider the importance of small device firms in medical device innovation.
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From page 48... ...
Such an improvement wait need to take into account that the development of clinical procedures is a very different endeavor from that of drugs and devices. The development of especially incremental innovations often occurs in a decentralized manner, involving change and refinement of a particular procedure by numerous physicians.
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From page 49... ...
may be found in the assessment teams now being initiated by the National Center for Health Services Research to evaluate alternative technological options available in the management of clinical conditions. These teams are to undertake the equivalent of Phase ~ and Early Phase IT studies now undertaken for `drugs, make recommendations for clinical trials (Phase IlI)
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From page 50... ...
Such an approach would strengthen the clinical evidence on which development decisions are made, and probably would improve the cost-effective use of health care resources. Table I: Comparison of Effectiveness/Efficiency of Technology Development l Drugs Devices Clinical | Procedures · R&D Investment +++ + ?
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From page 51... ...
may be inappropriate3. In view of the increasing numbers of alternative or competing technologies being developed, it seems especially important to provide comparative evaluations of the relative safety and effectiveness of technological options available in the management of clinical conditions.
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From page 52... ...
For example, the workshop might consider alternative models for assuring the systematic evaluation of clinical procedures. It is only by addressing these complicated issues that will we be able to improve the effective and efficient transfer of research findings into clinical practice, and thereby strengthen a crucial link in the medical innovation chain.
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