InCHOIR
International Center for Health Outcomes and Innovation Research
 
Clinical Research

Methodological Research

Policy Analysis

Technological innovation in medicine

Academic medical centers

Coverage decision-making and basic benefit packages

 
Patient Safety

POLICY ANALYSIS

Technological Innovation in Medicine

Allocation of Research Budgets -- Innovation is a learning process that takes place over time, and a fundamental aspect of learning is the reduction of uncertainty. Although economists have emphasized the role of uncertainty in all research activities, they have paid particular attention to the uncertainties that existed ex ante; that is, prior to the first introduction of a new technology. By contrast, our research has documented the extended persistence of uncertainty in the medical arena, as well as the varying reasons for its uniquely high persistence in this area. In our New England Journal Sounding Board article, we highlight some of the policy implications of the persistence of uncertainty, and review what steps can be taken to accelerate the discovery and introduction of new uses for drugs and devices. We also discuss briefly what should the roles be of the public and private sectors in providing support for the basic, translational, and clinical research that will make this happen. We are planning to build upon this work by exploring in greater depth the consequences of "downstream uncertainty" for the allocation of health-related research budgets. More generally, we will be looking at allocation decisions within the NIH budget, and the roles played by both the public and private sector in providing research support.

Academic Medical Centers

The Changing Nature of Research -- Central to these themes is the role of universities, especially academic medical centers, as institutions that generate and transmit economically useful knowledge, with which we mean mainly technological knowledge. In particular, InCHOIR faculty has formed a research collaboration with the School of International and Public Affairs at Columbia University, and the department of economics at Stanford University, and has built a database on inventive activity at several American research universities. One important source of data is the "invention reports" that virtually all universities have been collecting since the Bayh-Dole Act was passed in 1980. These invention reports, and other information connected to them, such as research financing and licensing, have provided an extremely interesting window into the kinds of university research that have been contributing to the advance of different technologies.

We explore the factors that lie behind the post-1980 surge in university patenting and argue that we see little evidence of a shift from basic to applied research, which has been a concern voiced by several observers of the innovation process. An important research question that we have begun to address is whether the enactment of the Bayh-Dole Act, and the associated creation of "university offices of science and technology," have increased the effectiveness of technology transfer from universities to industry.

The Industrialization of Clinical Research – An interesting area of research is the emergence of contract research organizations, site management organizations, and central or commercial institutional review boards (IRBs) in response to the outsourcing of clinical trials by the drug industry. We are considering the implications of these developments in general, for AHCs, and for the protection of human subjects. Top

COLUMBIA-STANFORD CONSORTIUM ON MEDICAL INNOVATION –- The overall objectives of the Consortium are three-fold: (a) to train a new generation of policy-oriented researchers that transcend their disciplinary training to think critically about the inherently interdisciplinary and complex dynamics of medical innovation; (b) to conduct research projects that carefully analyze how historical, economic, institutional, and regulatory factors affect the rate and direction of innovation in the pharmaceutical industry--and medicine more generally--as well as suggest promising areas for future policy change; (c) to disseminate these results to a wide range of important players in the health care arena.

AMCS AND THE DIFFUSION OF MEDICAL TECHNOLOGY -- A grant from the Commonwealth Fund and its Task Force on Academic Health Centers is supporting an examination by faculty of the role of academic medical centers (AMCs) in the diffusion as well as the developement of innovations, as distinct from their development. An initial literature search reveals that little of consequence has been written. Therefore, we are proceeding by a combination of case studies in the area of cardiovascular disease and interviews with academic chiefs of cardiology and cardiac thoracic surgery to write an essay. We have already identified the overlap of generation and diffusion as an important aspect of this question, the importance of dissemination of new information and training of new specialists as academic roles that undermine the ability of an AHC to establish comparative advantage in the marketplace, and the structural weakness of AHCs in managing the entire innovation process to their economic benefit.

University-Industry Interactions -- Our research on the changing nature of university-industry interactions expands on the previous research topics. There is a common image of the traditional relationship between industry and universities, which assigns to universities the role of generating fundamental knowledge and to industry the conduct of applied research and the development of medical technology. Medicine is a fascinating field in which to explore this supposed division of labor, because a closer look at the ways in which medical innovation arises and spreads suggests that both parties perform more complex and subtle roles than conventional wisdom maintains. The Center has taken a leadership role in a panel of the National Academy of Engineering that looks at the impact of academic research on industrial performance in the medical device sector. Partly as a result of this work, we have begun to look at how one might design new modes of interaction between universities and industry while preserving the core mission of the university.Top

Coverage Decision-Making and Basic Benefit Packages

A critical junction in the innovation process is the transition from "experimental" to "accepted" medical technology. Coverage decisions are inevitably made in the face of considerable uncertainty about indications, populations, risks, and effectiveness. The stakeholders –scientists, purchasers, managed care organizations, physicians, and patients—all seek "evidence" to guide coverage decisions. But all bring their own distinct readings of evidence to decisions that often have heart-rending implications for quality, cost, and fairness.

Several members of the Center have begun exploring the complexities of building systems and processes that guide the transition and translation of clinical investigations into clinical practice and are using cross-national analysis to offer suggestions on how to build such systems and processes. In particular, we address the following questions: (1) What criteria guide coverage decisions? (2) What kinds of evidence are required in framing coverage decisions? (3) Who does and should support the underlying assessments? And (4) what are the main analytical, institutional, and practical challenges that arise in making coverage decisions? Another focus within this domain is to look at insurance coverage denials, using a survey of managed care organizations.

 

 

 

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