Clinical Trials: A Wider Lens

There is general agreement in science and medicine that an important strategy to enhance the knowledge necessary to develop new therapeutic regimens for treating and preventing disease is through and randomized clinical trials. It is worth repeating that clinical trials of any sort are experimental in nature by virtue of the fact that the outcome is unknown and the risks of participation are uncertain. This said, there are a number of components to such experimentation with humans that should be taken into account. Clinical trials necessitate the voluntary and informed participation of humans, diseased and healthy. Historically, in what are considered the developed countries of the world--including the United States--experimentation in the name of medical advances have demonstrated a callous disregard for human life and dignity; doctors and other members of the healing professions have committed atrocities and abuses that revealed them to be capable of great injustice by using their profession to brutalize pe ople (Advisory Committee on Human Radiation Experiments, 1996; Katz, 1984; Moreno, 2000). Since the adoption of the Nuremberg Code (Annas & Grodin, 1992), safeguards to protect human participants in research experimentation have been established. The author of "A Call to Action" encourages social workers to act on behalf of scientists as surrogate recruiting agents for clinical trial participation. They suggest that social workers are well-placed to take on this task because of the nature of their professional abilities, their connection to community, and their access to patient participants. Each of these social work attributes is highly respected and regarded and should be protected. The author detailed the nature of a clinical trial and stated that there is benefit to such participation whether immediate or long-term, either directly to the participant or to others in the future. However, there are also risks to participation in clinical trials, and these need to be presented with greater emphasis than the benefits because a patient's state of mind may be compromised by emotional stress and therefore attuned to hearing positive information (Rowland & Massie, 1998). The risks of joining a trial have to be highlighted simply, straight-forwardly enumerated, and discussed as a real possibility. Too often the risks of joining a clinical trial are buried at the end of a complex consent form, the end of the discussion of the trial itself, or presented in complex statistical terminology, often not understood by would-be participants. Clinical trial participation may be interpreted by a patient as providing the benefit of a hard-to-come-by treatment. However, in actuality the patient is a participant in a study to determine the efficacy of the new treatment. Making an informed decision to join a clinical trial is difficult and can be exacerbated by emotional stress and physical pain. The factors leading to the decision to join a trial are even more convoluted and misleading when it is suggested that the trial is a "promising new treatment." The determination of "promising" or "injurious" has to await completion of the trial and analysis of the data, which may be several years after the patient's participation. Clinical prevention trials necessitate the voluntary participation of healthy people who do not have any manifestation of underlying or overt disease. Such trials are essential to medical advances that further the prevention of diseases, but they are also both scientifically and ethically complex. An especially important and intricate set of questions associated with prevention-oriented clinical trials concerns the reasons for which individuals volunteer to participate and the nature of the commitment they make. One example was the Breast Cancer Prevention Trial (BCPT). The title itself is a misnomer as it includes the word prevention. The BCPT sought healthy women who were consider at "high risk" of developing breast cancer to determine the worth of the drug Tamoxifen as a cancer preventative. …