Clinical research is not just the foundation but the bedrock of evidence-based medicine. We can confidently determine the best course of action for our patients by systematically collecting information on the outcomes of specific treatments. However, the execution of clinical research is a crucial area where we, as a medical community, can still be better and strive for continuous improvement.
When I joined my first medical practice, fresh out of my fellowship program, I was immediately invited to serve as the primary investigator (PI) on a research study. From an academic perspective, this was an exciting opportunity. Being considered a PI meant that the funding institution trusted your scientific and clinical judgment and that you contributed to the scientific knowledge base.
However, the situation didn’t turn out as straightforward as it first seemed. The offer to become the PI did not come from a government-funded research grant to improve public health. Instead, it was extended by a for-profit drug company with a clear agenda: to secure FDA approval for its medication for a new medical condition.
This realization produced considerable internal conflict within me. On one hand, I wanted to contribute to the body of scientific knowledge. I wanted to help discover new, effective treatments for patients in need of relief from pain. And if everything were done correctly, that would be the outcome.
The study results would show the treatment’s effectiveness, or lack thereof. Ultimately, we would gain more scientific knowledge and a deeper understanding of how to improve patient outcomes, as well as what would not improve them, and learn from that as well.
However, the weight of the incentives blurred the lines. I found myself enthusiastically introducing the study to new patients, all the while grappling with the ethical implications of the research. Explaining the benefits and risks, as well as deciding whether a patient met the inclusion criteria or was medically ineligible, all involved subjective components that weighed heavily on my conscience.
As a relatively new physician, I contemplated how the opportunity to earn $2,000 for each patient I enrolled in the study might influence my clinical judgment. The sponsoring company engaged in significant outreach, including hosting elaborate events and covering the expenses for my attendance at prestigious conferences to discuss the research study.
At every step in that process, the physician in charge can influence the outcome. The incentives that physicians are offered, as well as their magnitude and structure, affect how doctors experience making these decisions.
Some doctors are not only concerned about the financial incentives they receive. Patients can also have conflicts of interest due to their compensation for participating in studies and the unaffordability and limited availability of certain medications.
Conversations with other doctors and research coordinators revealed a concerning trend. Some patients participated in clinical trials of new drugs not solely to advance medical science, but also to supplement their income or gain access to medications they could not afford otherwise.
Legally, patients cannot be paid for trying new drugs due to concerns that low-income participants may end up bearing the brunt of the risks involved in testing new drugs due to their need for money. However, companies are allowed to compensate patients for their time spent participating, and compensation of up to thousands of dollars is often approved by ethics review boards, some of which are for-profit entities paid by drug developers to review and approve studies.
Any way you describe it, thousands of dollars are a powerful incentive for a low-income patient to participate in a clinical trial instead of receiving standard-of-care treatment. Some clinical trials even require that patients be checked against databases of enrollment in other trials to ensure that the same person is not enrolled in multiple trials simultaneously for financial reasons.
While working on this article, a colleague told me she once had to disqualify a patient from participating in clinical research at her facility after a mandatory cross-check revealed that the patient was already enrolled in a different clinical trial — and that the patient had given different answers to questions about her medical history to the other study team. This patient provided answers that would allow her to meet the inclusion criteria for participation in highly paid clinical trials.
Another colleague shared that he had patients who were experts at finding clinical trial databases related to their conditions, because clinical trials were the only way they could afford access to the latest medications.
Clinical research is the bedrock of evidence-based medicine. Rigorously designed and executed clinical trials are the only way to learn which treatments improve patient outcomes and which don’t. Therefore, we must empower our patients by showing them the importance of their participation in research. This is not just a professional duty, but a commitment to the well-being of our patients, a commitment we must uphold with empathy and care.
As a society, we must be acutely aware of the need to mitigate conflicts of interest in all aspects of clinical research. This is not just a matter of professional ethics but a fundamental requirement for the integrity of medical science and the well-being of patients. We all have a responsibility to be vigilant about this issue, ensuring transparency and thereby instilling confidence in our research.
Is it a good idea to pay PIs a fee per patient enrolled, or should they receive flat payments for site participation? Should there be stricter regulations on how patients are compensated for participating in research, or would that only take money out of the pockets of sick patients struggling to make ends meet?
As a medical community, we need to consider these questions to ensure the ethical conduct of our research. The choice of appropriateness for a patient’s participation in a clinical trial lies ultimately with the PI. This is a sobering and critical responsibility that should always be foremost in the PI’s consideration throughout every trial.
How can ethical integrity in clinical research be safeguarded? Share in the comments.
Dr. Francisco M. Torres is an interventional physiatrist specializing in diagnosing and treating patients with spine-related pain syndromes and general musculoskeletal disorders. He is certified by the American Board of Physical Medicine and Rehabilitation and the American Board of Pain Medicine. In his free time, he enjoys working out, playing the violin, and spending time with his five grandchildren. He is a 2024–2025 Doximity Op-Med Fellow.
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