Ethical Considerations In RCTs With Diabetic Patients

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Author(s): 
Farah Siddiqui, DPM

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.

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Desmond Bellsays: June 7, 2011 at 8:29 pm

Great topic and well written article. Thank you for your contribution.

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DR DPMsays: June 22, 2011 at 9:52 am

Clinical research is always a timeless dilemma that is ample fodder for medical ethics. First of all, the purpose of clinical research trials (RCTs) is to meet the best interests of the patient more so than the individual interests of the physician scientist. It is never the other way around. If it was the other way around, nightmares like science fiction TV shows ("The Incredible Hulk" pilot episode in 1977 is the number one example) would occur. A "clinical experiment gone wrong" has myriad of negative consequences for all involved, more so for the physician scientist. Whether the physician scientist is an MD, PhD (Dr. David Banner), a DO, PhD, a DPM, PhD, or a MD, DO, or a DPM, the physician scientist must adhere to the well being of the patient.

Secondly, I feel that putting the patient in the placebo group for the duration of the clinical research project is fine ethically, despite the negative trade-off of potential possible minimum treatment quality (i.e, an inferior medicine). Informed consent should involve informing the patient he or she has a 50% chance of being in the placebo group, therefore receiving the minimum or inferior treatment. That is the only information the patient should know if the patient volunteers in a clinical research experiment.

Thirdly, the above two paragraphs involve a fine line of many gray areas. That is where the ample fodder for medical ethics come in. Each patient has his or her own unique potential moral dilemma once he or she participates in the clinical research project. So, if there are 2,500 patients involved in a clinical research project, then there are 2,500 unique potential moral dilemmas the physician scientist must tackle. The gist of the matter is this: first, where do physician scientists draw the line in terms of conflict of interest between the physician scientist and the patient. Secondly, how does one reconcile this conflict of interest with the informed consent?

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