Clinical trials: concerns of the patient and the public

Article Abstract:

While most cancer researchers advocate the recruitment of greater numbers of patients into clinical trials of treatment programs, there has been relatively little evaluation of how patients and the public at large regard such research. One study, which administered questionnaires to patients, found that 71 percent thought that patients should participate in clinical research. The individual patient's welfare was not seen as the primary benefit, however; 69 percent said that the benefit to society and medical knowledge were the most important reasons for participation. Thirty-six percent felt that the medical care which was received by patients participating in research was inferior to that received by patients of private physicians. In a related questionnaire, a full 70 percent believed the physicians conducting a clinical trial already knew privately which treatment was best. These concerns may be best appreciated by contrasting the results of a survey of physicians themselves, who were asked if they would participate as patients in six clinical trials that were being conducted at the time. The response ranged from 11 to 64 percent. A serious question is raised; can physicians ethically ask patients to participate in a trial in which they themselves would not participate? A related question concerns the basis upon which a patient makes a decision to participate. If physicians are hesitant to participate because of their greater knowledge, then it may well be said that patients are being asked to participate without being provided adequate information. In another study, lay people indicated that they would be strongly influenced by the knowledge of whether physicians would participate in a particular study, and that they would like to have this knowledge when making such a decision. It should be clear that several legitimate concerns must be addressed if greater public support and participation in clinical trials are to be obtained. Since patients rely on, and have confidence in, their private physicians, physicians as well as patients must be shown that the medical care received by patients involved in research is at least as good as that received elsewhere. (Consumer Summary produced by Reliance Medical Information, Inc.)

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Ethical considerations in randomized controlled clinical trials

Article Abstract:

The clinical trial is an essential part of the evaluation of novel drugs and treatment protocols. The randomized clinical trial, in which the patients are randomly assigned into the different treatment groups, is less susceptible to the introduction of bias, and is therefore often to be preferred. However, the random clinical trial, or RCT, is not without difficulties, and must be carefully designed in order to lead to reliable conclusions. Complicating the design of RCTs are important ethical considerations, which generally revolve around the need for control groups and the validity of informed consent. Ethically, it is difficult to withhold treatment known to be effective, and control groups must be designed with this in mind. The purely ''placebo'' control must be abandoned in many cases. In addition, especially with incurable diseases, the patient may agree to participate out of desperation; this is viewed by some as a form of coercion, rendering informed consent no longer valid. The authors suggest that enrolling patients in an RCT is ethical only if there is truly no reason to believe either treatment arm is to be preferred. This will relegate the RCT to situations where the experimental treatment and the traditional treatment are likely to yield very similar results. For treatments yielding well improved results, historical cases may be adequate for experimental control. The authors also suggest that the RCT be modified to take patient preference into account. Patients' treatment preferences should self-randomize; if they do not, that might be a clue into important perceived differences between the treatment groups. Although randomized clinical trials are often preferred by researchers, when alternative experimental designs are possible, ethics may demand that randomization not be used. (Consumer Summary produced by Reliance Medical Information, Inc.)

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Overview: current status of clinical trials

Article Abstract:

Numerous problems face the design and implementation of programs of clinical research, not the least of which is the general anti-intellectual attitude of our times. Often this attitude results in a ''double-bind,'' since the desires and fears of the public are often contradictory. This is most evident among patients with AIDS, who are afraid of being made ''guinea pigs,'' but who also insist that any drug which shows even the remotest chance of benefitting them be made available. Furthermore, they often demand that the fruits of research be made available in such a way that it is impossible to scientifically assess the results. Behind this general cultural orientation are more mundane but nevertheless difficult problems. How can clinical research be integrated into a health care system which itself is in chaos? How can the science of clinical trials be improved? How may more patients become involved in clinical trials without compromising the ethics of medical practice? And of course, questions must always be raised about the management of clinical research. Can clinical researchers, community physicians, and the National Cancer Institute cooperate effectively at the same time each is trying to maintain and expand power and control? Ultimately, all of these questions influence the care that is received by cancer patients, and the care that will be received by patients of the future. Although the questions are not easy, they must be resolved if the care of cancer patients is to continue to advance. (Consumer Summary produced by Reliance Medical Information, Inc.)

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