Ethical Considerations In RCTs With Diabetic Patients

Farah Siddiqui, DPM

Evaluating The Potential Risks Of Clinical Trials To Patients With Diabetes

In patients with diabetes, as with any other immunocompromised patients, the risks of delayed wound healing increase threefold. More particularly with wound care, studies have documented an increased risk of infection, hospitalization and amputation directly proportional to the length of time a wound remains open.4 Wounds may or may not respond to certain therapies, and therefore have a higher chance of developing an infection.

   One may ask: Is this a risk worth taking? Does one just abandon the efforts of clinical trials? Should randomized clinical trials be abandoned and should intermediate level evidence suffice? How can progress occur if there is no sound clinical evidence to support new therapies?

   The involvement of patients with diabetes or any patients in clinical trials poses many risks, including physical and economic risks.5 Although many products being tested on diabetic wounds go through initial safety testing and are released on the human market only if they are found to have minimal associated risks, every patient will react differently to different products. With the new developing therapies, there are chances of discomfort or inconvenience.

   Also, many studies have an initial screening period that may last anywhere from one to four weeks. During this time, no treatment occurs. This in many cases prolongs the time in which patients receive care. However, if one considers the chronicity of the wound or condition, this may just be a trivial amount of time.

   Additionally, not all research studies offer patients financial support and thereby cause the patient to incur financial obligations. Typically, research studies require patients to have frequent clinic visits, which then require the patient to take time off from work and pay for transportation.

   Many wound care studies require offloading, which limits the amount a patient can work and may even necessitate time off work. However, research trials do give the underinsured and/or economically disadvantaged patients the opportunity to have therapies they may otherwise not have access to or afford.

In Conclusion

The dual role that a physician and researcher assumes when agreeing to participate in such trials can be problematic and risky. A conflict of interest may occur because the goal of carrying out important and valid research might conflict with the goal of acting in the best interests of the individual patient. While physicians have a duty to their individual patient, one can argue that physician researchers have a duty to a larger demographic of patients who may benefit from advances in medical knowledge.

   It is important to ensure the protection of potentially vulnerable populations such as patients with diabetes or the economically disadvantaged, who may feel compelled to enroll in such studies due to a lack of options. Objective guidance from their physician can help patients make a decision but patients should feel comfortable with the decision they make and the position in which they are putting themselves. While the physician researcher has multiple interests, the primary interest should always be the patient and his or her best interests.

   Dr. Siddiqui is a Diabetic Limb Salvage Fellow in the Department of Plastic Surgery at Georgetown University Hospital in Washington, D.C.



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

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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