Recommending Clinical Trials to Patients -- Addressing Physician Concerns
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 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?
There are a number of sources of 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.
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 of their own accord. Often this can represent "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 in newspaper, radio, and TV ads to ask their doctor. Finally, what seems successful to you -- improved control of rheumatoid arthritis or reduced frequency of asthma flares, for example -- may not feel like success to your patient. A discussion of clinical trials can start a conversation about successful treatment. It may be that there are reasonable alternatives -- pills in place of injections, medications that can be taken fewer times per day or with fewer side effects -- that both you and your patient would want to pursue
through a trial. And it is always important to explain clearly to patients that all clinical trials are by their nature experimental, and that changing
from a proven treatment to a clinical trial is inherently uncertain.
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 to my office?
No, when a patient starts a clinical trial one of our study coordinators will contact your office after the patient signs the informed consent and a records release form. They will ask that your office send us a few clinical notes from the patient's record pertinent to to the disease under study. You also will receive a letter if and when the patient is randomized into the study about the study agent and the trials course. At the end of the trial, the study coordinator will send you another letter stating that the patient has completed the trial and copies of that patient's labwork, EKGs, and any x-rays taken. Of course, if the patient has any medical issue that is discovered through routine study procedures, we will notify you right away and will always refer the patient back to you for their routine care.
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.
Created by Medscape. Information provided by VeritasMedicine.com.
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 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?
There are a number of sources of 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.
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 of their own accord. Often this can represent "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 in newspaper, radio, and TV ads to ask their doctor. Finally, what seems successful to you -- improved control of rheumatoid arthritis or reduced frequency of asthma flares, for example -- may not feel like success to your patient. A discussion of clinical trials can start a conversation about successful treatment. It may be that there are reasonable alternatives -- pills in place of injections, medications that can be taken fewer times per day or with fewer side effects -- that both you and your patient would want to pursue
through a trial. And it is always important to explain clearly to patients that all clinical trials are by their nature experimental, and that changing
from a proven treatment to a clinical trial is inherently uncertain.
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 to my office?
No, when a patient starts a clinical trial one of our study coordinators will contact your office after the patient signs the informed consent and a records release form. They will ask that your office send us a few clinical notes from the patient's record pertinent to to the disease under study. You also will receive a letter if and when the patient is randomized into the study about the study agent and the trials course. At the end of the trial, the study coordinator will send you another letter stating that the patient has completed the trial and copies of that patient's labwork, EKGs, and any x-rays taken. Of course, if the patient has any medical issue that is discovered through routine study procedures, we will notify you right away and will always refer the patient back to you for their routine care.
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.
Created by Medscape. Information provided by VeritasMedicine.com.
