Ethical Considerations In RCTs With Diabetic Patients
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.
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.