Ethical Considerations In RCTs With Diabetic Patients
At the conferring of medical degrees, physicians take the Hippocratic Oath, in which they make a covenant to practice medicine to the best of their abilities. As the oath states, “I will apply, for the benefit of the sick, all measures (that) are required.” The physician has a duty to promote the patient’s best medical interests and therefore is obliged to advise the patient to receive the treatment that the physician prefers.
Although the driving force behind clinical research is the betterment of patient care, there is a substantial risk that physicians take by encouraging their patients to enroll in clinical trials. It becomes an even greater risk when the physician is also the researcher.
The aforementioned duty is what can create a barrier to the enrollment of patients in randomized clinical trials (RCTs). On one hand, patients may receive treatment they would otherwise not have access to getting. On the other hand, they may be randomized into the placebo group, which may or may not stall their medical therapy for weeks, even months. Although the Food and Drug Administration and Institutional Review Boards have many committees and regulatory procedures in place to ensure the protection of patient rights, there is still a moral dilemma that arises when a patient is randomized into the placebo group.
Assessing Our Obligations To Patients
When enrolling patients in clinical trials, physicians have two obligations to patients.1 The first obligation is to recommend the treatment that is, in the physician’s professional judgment, the best choice for the patient. With clinical trials, the placebo or the standard of care is what the medical community believes to be the “superior” treatment. Although the active treatment group may also seem superior, these judgments are tentative and have no real substantial evidentiary basis.
In current clinical research evaluating products for diabetic foot wounds, saline gauze or hydrogel is commonly used as the control even though many other products have been proven by well designed trials to be more effective.
Herein lies the physician’s dilemma: Is the fact that we are using a known inferior product as the placebo considered unethical?
In this example, however, these trials do offer an advantage to the placebo groups. Due to frequent return clinic visits, frequent debridement of the wounds occurs and this has been documented to increase the rate of wound healing.2 Although patients are receiving a product that is not the most optimal for the wound, the patient is still receiving focused care, which he or she may not be receiving otherwise if the patient was not involved in the trial.
The second obligation to patients is to obtain the patient’s informed consent. This is perhaps the saving grace for physicians involved in clinical research. Respect for a patient’s values is the core purpose behind the informed consent. The informed consent entails explicit explanation of: the goals of research; potential risks and benefits; reasonable alternatives to the recommended treatment; and the right to withdraw from the trial at any time.3 It is the responsibility of the researcher to educate the patients objectively and make them understand that involvement in the research may or may not be of personal therapeutic benefit.
Ultimately, the impetus should be in the patients’ hands. Patients themselves may place a greater value on participation in a study, which will contribute to medical progress and to the well being of patients in the future.