What happens to a patient after I refer them to a clinical trial? Do they leave my practice?

What happens to a patient after I refer them to a clinical trial? Do they leave my practice?

Referring patients to a clinical trial is similar to referring them to a specialist. They remain your patients and should be scheduled for routine follow-up care as you deem fit. They may (and likely will) receive an evaluation and some form of treatment from the clinical trial, just as they would from a specialist. You should expect regular communication from health care professionals at the trial, just as you would from a specialist.

If a patient expresses interest in participating in a clinical trial, where should I look for information?

If a patient expresses interest in participating in a clinical trial, where should I look for information?

There are a number of sources for information on clinical trials, most of which are designed for patients. One of the best places to start is ClinicalTrials.gov, which is run by the National Institutes of Health. It contains background information on clinical trials, their purpose, and how they are organized, as well as a searchable database listing thousands of government-sponsored and industry-sponsored trials. Several Web sites specialize in clinical trials, including EmergingMed.com, VeritasMedicine.com, and CenterWatch.com. See WebMD Clinical Trials Services for links to these resources and more on WebMD.com.

How should I respond to a patient whose current therapy is working but who approaches me about participating in a clinical trial?

How should I respond to a patient whose current therapy is working but who approaches me about participating in a clinical trial?

Patients have different reasons for bringing up the issue of clinical trials. Often a reason can be "treatment fatigue": patients are tired of taking their pills and are looking for an easier alternative. Media campaigns and direct-to-patient advertising are common strategies for new treatments and for clinical trials, and patients may be encouraged by newspaper, radio, and TV ads to ask their doctor.

Do patients ever participate in trials because of financial incentives? If so, how should I counsel such patients?

Do patients ever participate in trials because of financial incentives? If so, how should I counsel such patients?

This is a rarely encountered problem. Although some clinical trials offer either a cash stipend or free medications as a way to improve enrollment, these incentives are considered to be remuneration—ie, fair payment for participation. The use of financial incentives solely for the purpose of recruiting patients is considered unethical.

Every trial has to be reviewed by an Institutional Review Board (IRB) before it can enroll patients, and the financial remuneration is closely monitored. Thus, very few trials offer significant amounts of money, and there has never been a described "cottage industry" in clinical trials enrollment (in contrast to people who frequently donate blood for payment).

If you sense that patients are considering a clinical trial purely for financial reasons, you should have a frank conversation with them about the risks and benefits of a trial, as well as the attendance, blood testing requirements, and other stipulations of the particular trial.

Will patient participation in a clinical trial pose an administrative burden on my clinic?

Will patient participation in a clinical trial pose an administrative burden on my clinic?

Some physicians are part of groups or networks that have a contractual relationship with a research organization that administers clinical trials. For them, administration is generally handled outside the clinic, by the research organization.

Other physicians often have a research affiliation with a medical school or hospital. In those situations, there is often a research coordinator (usually a nurse) connected to the clinic who is responsible for trial administration. Research nurses may be paid by the clinic, by the research institution, or both.

For most physicians, however, referral to a clinical trial is an occasional event. As a general rule, when you refer a patient, trial organizers will handle administration. Most trial coordinators want to make it as easy as possible for you to refer your patient, and are aware of the burdens of unnecessary paperwork. The first step—figuring out what phone number to call and how to get your patient into the system—is usually the toughest. After your patient enrolls, you will likely have data forms to fill out each time your patient is seen by you. Typically, these are incorporated into your regular clinic note.

Will my staff require additional training?

Will my staff require additional training?

If there are data forms to be filled out each time your patient visits, you and your staff will likely be instructed on how to fill out these forms accurately. Typically, however, minimal training is necessary.

Where should I direct patients who have questions about their insurance coverage if they participate in a clinical trial?

Where should I direct patients who have questions about their insurance coverage if they participate in a clinical trial?

Patients should be instructed to discuss their participation in a clinical trial directly with their insurance carrier.

Is referring my patient to a clinical trial an admission of failure?

Is referring my patient to a clinical trial an admission of failure?

As a physician, you may feel that referring a patient to a clinical trial reflects your inability to effectively manage his or her disease. This is not the case. Clinical trials generally involve experimental treatments. Having advanced to phase 2 or phase 3 studies, these treatments represent the most promising new treatment options coming down the pipeline. Because they are experimental, they are not available through any other mechanism, and they are designed specifically to address clinical problems that have not been solvable using existing treatments.

What are the key ethical considerations involved in patient participation in clinical trials?

What are the key ethical considerations involved in patient participation in clinical trials?

The ethical considerations for clinical trials generally fall into 2 categories: informed consent and financial incentives.

Informed consent derives from a long history of examining coercion in research. An example that is familiar to many is the Tuskegee Syphilis Study, in which 400 low-income African-American men were deprived of available, effective treatment for decades, in order not to interrupt the experiment. This project eroded African-Americans' (and others') trust of medical research studies and is partly responsible for the low representation of African-Americans in medical research today. Efforts to prevent similar occurrences led to the process of informed consent, whereby patients must indicate that they understand fully the risks and benefits of participating in medical research. Informed consent is currently entrusted to 2 groups: study investigators, who must document that patients have given their informed consent; and Institutional Review Boards (IRBs), independent panels that review every study and authorize that the risks to patients are minimal and are fully explained before the patient enrolls in the trial.

The issue of financial incentives has become more confusing with the recent ties forged between industry and individual scientists and physicians. Whereas in the past, financial incentives were largely given to patients, they are now increasingly offered to physicians for enrolling their patients. Several public and private groups have been lobbying to curtail the financial incentives that industry offers to physicians, and it remains a heated topic for debate with respect to clinical trials. There are no uniform guidelines, and rules vary from institution to institution. In general, physicians should be clear with themselves and with their patients about any compensation they are receiving from industry.

Where can my patients and I find more information on clinical trials?

Where can my patients and I find more information on clinical trials?

The National Institutes of Health maintains a site called ClinicalTrials.gov. Here you will find a registry of all federally and privately supported clinical trials conducted both in the US and around the world, as well as information explaining how clinical trials are conducted.