Why Primary Care Physicians Don't Refer Their Patients to Clinical Trials

John Hogan, M.D., Medical Officer, Unity Health Care, Inc., Washington, D.C.

In explaining the type of organization he represents, Dr. John Hogan stated that Unity Health Care in Washington, D.C., is a large conglomerate (23 sites) that started as Health Care for the Homeless and two public health clinics. Principal investigators from a clinical trial supported by NIAID provide care for HIV patients at Unity Health Care. The clinic's patients come primarily from Vietnam, Latin America, the Caribbean, and Africa.

Dr. Hogan explained that he polled his colleagues to arrive at an answer to the question of why primary care physicians do not refer their patients to clinical trials. The basic problem is a deep-rooted distrust of the health care system, which has existed for many years. The problem originates with patients who do not have direct access to research institutions and physicians who do not work in them.

A caring community physician who has worked hard to dispel his or her patients' basic distrust of the system and then agrees to refer patients to a clinical trial often wonders what is going to happen to them when they get there. The referring physician often must deal with the patients' fears regarding clinical trials. In addition, the physician has to monitor patients' behaviors and fears while they are in the clinical trial.

Dr. Hogan examined the root of this distrust and some truths, myths, and legends associated with it:

• Truths. The Tuskegee Syphilis Study and the U.S. military's use of LSD on soldiers were trust-breaking occurrences. The only way to repair the broken trust that resulted from these mistakes is through time and consistency.

• Myths and legends. There are Web sites that claim that HIV is a virus made by scientists, pharmaceutical companies, and American physicians as an agent for African American genocide. Another belief is that HIV medications cause all the symptoms of AIDS and HIV infection; therefore, the HIV virus does not exist and the medications should not be taken.

A moral issue is involved in the topic. Patients should have access to health care through participation in clinical trials. The ethical dilemma involves the situation of the have-nots who are desperate for access to health care and researchers who are interested primarily in advancing science through their trials. Unfortunately, not enough physicians or health care workers view the disenfranchisement of patients who have little access to medical care as a moral issue. Those who do are stretched very thin.

Common reasons that providers give for not referring their patients to clinical trials include (1) not having time because they are too busy trying to "pay the bills," (2) not having time to keep up with what is available or to research the studies, and (3) not having the staff to do the research. They also claim that they forget to refer their patients.

Educating the Provider

Physicians must be alerted to the fact that they need to learn about clinical trials for their patients' sake. Many of them need help in realizing the possibility and the importance of patients getting medical care through participation in trials. In addition, physicians must be encouraged to "come out of their comfort zones" and use creativity to address the problems faced by their patients in clinical trial participation. Some doctors want to support clinical trials but do not know how to access the resources that contain information about them. The Internet is one way to access information about clinical trials, but how many physicians have time to look up this information?

Another problem involves the small number of doctors in private practice who know about the phases of various clinical trials. Physicians must be educated on this topic before they send their patients to clinical trials. They also need to know what the trial offers patients in terms of advancing science versus offering a treatment or cure. Community-based physicians do not usually have patients who are interested in advancing science; their patients are interested in better medications or a vaccine. Both patients and clinical trials must be screened to determine their appropriateness given the needs and desires of each.

Educating the Patient

After a physician finds a patient who is compliant and would be a good candidate for an existing clinical trial, the physician must educate the patient about a clinical trial. At the same time, the referring physician must feel comfortable with the investigators and the trial protocol and must feel confident that his or her patient will be comfortable in the trial setting in terms of language and trust. In addition, the referring physician must explain to the patient why he or she is being sent to a different location for medical care.

Patients' expectations also play into the problem. If the patient is expecting treatment for a medical problem (e.g., an HIV patient who wants to try a new medication) and the trial is in the first or second phase, then treatment will not be available. Instead, participants will be screened for acceptance into a later phase of the trial. The issues of advancing science and financial gain also must be considered.

Uninsured Patients

An article titled "Enrolling the Uninsured in Clinical Trials: An Ethical Perspective" in Critical Care Medicine⁶ addressed some issues from the patient perspective that Dr. Hogan thought should be answered first by the referring doctor. The question involves the patient's lack of options. Regarding clinical trials, uninsured or underinsured patients have no other avenue to get treatment and are in a desperation situation. The doctor must consider which hospitals will take an uninsured patient and how long the hospital will accept Medicaid. Discovering a clinical trial puts pressure on the doctor and on the patient who has nowhere else to go and no access to medical care. If the trial involves medication, at the end of the trial the patient will be given a 3-month supply, but after that the patient reverts to Medicare, which does not have medication coverage. For example, a patient with non-Hodgkin's lymphoma might get treatment for the disease in a clinical trial, but when the trial is over, the medications cost $350 a month. The physician must question what his or her patient is going to do after the trial is over. A lack of health care options makes individuals susceptible to pressure to enroll in clinical trials. Where else can they go for state-of-the-art care? And where do they go after the trial for followup care and medication?

Dr. Hogan ended his presentation by stating a question likely to be asked by patients: "Why am I in such demand as a research subject when nobody wants me as a patient?" Likewise, he asked: "Why are you [investigators] all coming to my office begging for my patients?" What about the ethical issues involved in physicians using patients as bargaining chips for personal gain? The most significant ethical dilemma involves private physicians' lack of trust, which must be dealt with through education. In conclusion, Dr. Hogan stated that the number one reason that his patients continued their participation in the NIAID clinical trial was the positive treatment they received from the staff.

Discussion

Dr. Hogan's presentation prompted the following questions and comments:

• A participant voiced "the dirty little secret" that community and academic physicians do not refer patients to clinical trials because of politics and the fear of losing patients. One hospital does not want to lose patients to another, and oftentimes patients seek out clinical trials because they are not happy with the care they are getting from their private-practice physicians. Dr. Hogan agreed that physicians might fear losing patients through referrals. However, he pointed out that to be admitted into a clinical trial, a patient must have a private doctor to whom the trial site can send the patient for care unrelated to the trial. Investigators must educate physicians about the requirement for trial participants to have a primary care doctor. Dr. Hogan also pointed out that providers must enlist the aid of their nurse case managers to keep a list of particular clinical trials and patients who might be qualified to enter them. Dr. Cargill mentioned a 2002 pilot survey of African American physicians on the topic of referral to clinical trials; the survey results confirmed the political nature of the problem.

• An attendee asked if financial incentives can be offered to primary care physicians for referrals to clinical trials, especially since many clinical trial participants see their primary care doctor very infrequently. Dr. Hogan reiterated that when patients are referred to a clinical trial, they must continue to see their primary care providers for comorbid conditions, such as high blood pressure and diabetes, because the trial investigators will not treat them for those conditions. The relationship between primary care physicians and patients must be maintained. Dr. Cargill added that a way to break down the barrier of mistrust regarding clinical trials is to emphasize the benefit that accrues when clinical trial information, such as lab values, is conveyed to primary care providers who then become involved in their patients' general health care. Although monetary rewards would not be appropriate per se, primary care providers could benefit from feedback about their patients. Dr. Hogan stated that a clinical trial that failed to convey lab results to a primary care physician does not deserve its referrals. Dr. Cargill added that a focus group of primary care physicians in Cleveland stated that one of the main reasons they would continue to refer patients to clinical trials would be to continue to get lab results, and one of the biggest reasons they would stop is because they failed to get the information about their patients. In addition, people who participate in clinical trials have a survival benefit. Another attendee pointed out that some clinical studies are not designed to deliver feedback. For example, phase I clinical trials are of no particular benefit to the patient; they are carried out to determine inclusion or exclusion.

^6. Pace C et al. Enrolling the uninsured in clinical trials: an ethical perspective. Crit Care Med 2003;31:S121-5.