The randomized clinical trial (RCT) has been the bulwark of the development of effective and safe medical and surgical therapy. Developed over the last half-century, they have proved the benefit and safety of new drugs and procedures and provided guidance to physicians in choosing therapeutic choices for their patients. They have replaced intuitive care that had largely directed medical care for centuries with a degree of science in making therapeutic decisions.

Although less than perfect, the RCT has been the reason for the remarkable success that we have achieved in decreasing the mortality of heart disease. This success has been driven largely by scientific altruism modified to some degree by the financial benefits of both the medical profession and the pharmaceutical industry.

As corporate hospital and third-party payers expand their role in the pattern of health care, there is the potential to make changes in how care is rendered beyond the choice of medical or surgical therapy. The expansion of care regionally and nationally provides tempting targets to modify the quality and efficacy on a large scale. It also provides potential cost-saving targets and generates corporate profits. Decisions at the corporate or administrative area in the past have been initiated on the basis of competitive costs and on intuitive decision making. The size of the market, however, provides an opportunity to test a variety of administrative plans that can lead to cost saving. These initiatives, well-meaning in their genesis, may result in patient participation in “studies” in which the patient may have a limited knowledge and benefit and uncertain risks.

RCTs demand informed consent by patients and unbiased temporal oversight by safety boards when searching for answers to questions based on contemporary knowledge. At present, there is no specific role for the patient’s voluntary and informed participation should a corporate representative initiate a “study” to answer a corporate question. Before we embark on “research” in patient care, it is imperative that we consider the principles established by RCTs. I propose two scenarios that may provide illustrative insight:

1. A nurse administrator wishes to explore the question of the cost savings achieved on a general medical ward by changing the current nurse staffing of eight professional nurses to a staffing with two professional nurses and six nursing assistants. The administrator will use personnel costs as the endpoint of the study and consider a variety of secondary issues such as the duration of time to respond to a call, sacral erythema, and wrong-dose administration, or other quality measurements.

2. The administrator of the catheterization laboratory decides to compare two catheters in the laboratory driven again by the costs of the catheters. The primary endpoint of the study will be cost savings. Secondary measurements will be time in the catheterization laboratory and postprocedure bleeding.

In both cases, the patient may or not have been informed about the research project in which they have been enrolled. In addition, there is no temporal assessment of the occurrence of adverse events that could occur during the progress of the “study” to ensure its safety. Many of the safeguards that have been developed around the RCT need to be incorporated into the design of these investigations.

This, of course, is all hypothetical, but on the other hand, it is not beyond the realm of possibility; as we move from “local care” to a system driven by anonymous personnel, it is important to obtain the consent of the patient and to establish procedures to ensure their safety.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.


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