Donna T. Chen, Franklin G. Miller, Donald L. Rosenstein | Annals of Internal Medicine | Volume 138, No. 8 | 15 April 2003
Abstract
All practicing physicians should be prepared to respond to requests from patients for advice about participating in clinical trials research. Even physicians who choose not to conduct clinical trials but rather devote their practice to clinical care may have patients who consider volunteering for research. In advising patients about clinical research, physicians enhance the physician-patient relationship and contribute to the overall goals of evidence-based medicine. We discuss several ethical and practical challenges facing physicians who wish to help their patients make decisions about volunteering for clinical trials. In addition, we suggest how preparation for advising patients about clinical research participation can be incorporated into the medical education process.
Over the past decade, clinical trials have grown enormously in number and are now more likely to be conducted in private practice settings than academic medical centers (1–3). They are commonly advertised in health sections of newspapers and on the Internet (4). Patients are increasingly seeking treatment through research participation instead of, or as an adjunct to, standard clinical care. Patient education guides recommend that patients consult with their own physicians when considering participating in a clinical trial (5). Accordingly, physicians are likely to be asked by their patients for advice about whether to enroll in clinical trials.
Physicians may be reluctant to discuss clinical research with their patients because of the uncertainty inherent in clinical research, lack of knowledge about the details of particular trials, and time pressures. Nevertheless, advising patients about research participation and considering referral to a clinical trial can be an important part of good clinical practice. The ethical challenges facing physicians who enroll their own patients in research or receive payment for referring patients to clinical research have received considerable attention (2–3, 6–8). However, the challenges facing physicians who are not recruiting patients for their own research or receiving referral incentives but rather helping patients make decisions about volunteering for clinical research have not been widely addressed.