Part 2 of 2
In Part 1 I wrote about clinical trials — what they are and how they are run. In this column I will discuss making the decision to participate in a trial and what you should know going in.
The decision to enroll in a clinical trial is one that should only be made after you have done a bit of homework. People who enroll in trials can play a more active role in their health care, gain a better understanding of diseases and treatments, gain access to new and perhaps more effective therapies, and help others. But there are usually some risks.
Here are some commonly asked questions adapted from the clinical trials website of the National Institutes of Health.
There are a number of sources available. Perhaps one of the best is your personal physician. You also can find out about clinical trials by contacting a teaching hospital near you. Many teaching hospitals have online listings of ongoing trials that are enrolling people. You also can look at a number of national sources such as Veritas Medicine and Center Watch.
Clinical trials are designed to answer very specific questions. Because the presence of other diseases or drugs may change the results of the study, most clinical trials have strict requirements for who can enroll. The requirements are described in the inclusions (who may enroll) and exclusions (who may not enroll) section of the protocol. Inclusion and exclusion criteria usually include the presence or absence of the disease or disorder, stage of the disease, age, previous treatments, and sometimes gender. Exclusion criteria should not be designed to exclude people on a personal basis (for example, because of race or ethnicity, unless the study is designed specifically to seek an answer to a question for people of one race). The inclusion and exclusion criteria should be based on sound scientific reasons that help to answer the question posed and ensure the safety of people in the study.
You should know as much as possible about the clinical trial before enrolling. A list of things to think about is noted below. You should feel comfortable asking the study staff and investigators these questions.
Every clinical trial in the United States must be approved and monitored by an institutional review board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates and others who ensure that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
Before you can participate in a clinical trial you will be asked to provide your informed consent. To do so, you must be told about the study, its risks and benefits, and exactly what will be done and how long you will participate. The researchers must be willing to answer your questions, and you should have as much time to think about enrolling as you need and the study design will allow. Once you have a good understanding of what is involved and what the potential risks and benefits are, you must be allowed to enroll voluntarily.
Informed consent is a process that requires good communication between you and the study staff. If English is not your native language, interpreters should be available. (Some studies use questionnaires that have not been shown to give reliable information in other languages. These studies may require people who enroll to speak English.) The process is documented using an informed-consent form. The form includes the details of the study, including its purpose, time requirements, procedures, risks, benefits and alternatives. You will be asked to sign the form, acknowledging that you have agreed to participate. You will be enrolled in the study when you sign the consent form. It is important to know that the consent form is NOT a contract. You can change your mind and decide against participating at any time
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan that details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports
You can change your mind and withdraw from the trial at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
Harold J. DeMonaco, M.S. is senior analyst, Innovative Diagnostics and Therapeutics, and the chair of the Human Research Committee at the Massachusetts General Hospital. He is author of over 20 publications in the pharmacy and medical literature and routinely reviews manuscript submissions for eight medical journals.