Should I Participate in a Clinical Trial?
Each patient diagnosed with cancer should at least be given the opportunity to consider a clinical trial. This option is highly individualized, and should be explored only after a diagnosis is made and the cancer is staged to determine how far advanced it is. Participation should always be preceded by a discussion between patient and physician about the benefits and risks of the trial, the patient’s long-term prognosis and the likelihood of a response to standard therapy. If a patient has already exhausted all standard treatments, a clinical trial may be the only remaining option.
Informed consent is a process by which people learn the important facts about a clinical trial to help them decide whether to participate. This information includes details about what is involved, such as the purpose of the study, the tests and other procedures used in the study, and the possible risks and benefits. In addition to talking with the doctor or nurse, people receive a written consent form explaining the study. People who agree to take part in the study are asked to sign the informed consent form. However, signing the form does not mean people must stay in the study. People can leave the study at any time—either before the study starts or at any time during the study or the follow-up period.
The informed consent process continues throughout the study. If new benefits, risks, or side effects are discovered during the study, the researchers must inform the participants. They may be asked to sign new consent forms if they want to stay in the study.
Am I Eligible for the Trial?
Each study has guidelines for who can or cannot participate in the study. These guidelines, called eligibility criteria, describe characteristics that must be shared by all participants. The criteria differ from study to study. They may include age, gender, medical history, and current health or performance status. Eligibility criteria for treatment studies often require that patients have a particular type and stage of cancer. This helps to ensure that the results of the trial will reflect the study criteria and not other factors, allowing researchers to achieve accurate and meaningful results. These criteria also minimize the risk of a person’s condition becoming worse by participating in the study.
How Will My Rights Be Protected?
Research involving human subjects is conducted according to strict scientific and ethical principles. All clinical trials that are federally funded or that evaluate a new drug or medical device subject to Food and Drug Administration regulation must be reviewed and approved by an institutional review board (IRB). At UCSF, the IRB is called the Committee on Human Research (CHR). At UCSF all clinical trials, regardless of funding, be reviewed and approved by the CHR.
Each clinical trial has a protocol that serves as a “recipe” for conducting the trial. Each study protocol at UCSF must clearly describe:
- The treatment to be studied
- Eligibility criteria such as age, tumor type, and disease stage
- What information will be collected such as maximum tolerated dose (MTD), safety, and benefits
Once approved, the protocol must be strictly adhered to by the researchers and medical professionals in the trial.
The CHR includes doctors, researchers, and other members of the community, and reviews the protocol to make sure the study is conducted fairly and participants are not likely to be harmed. The CHR also determines how often to review the trial once it has begun. Based on this information, the CHR decides whether the clinical trial should continue as initially planned and, if not, what changes should be made. The CHR can stop a clinical trial if the researcher is not following the protocol or if the trial appears to be causing unexpected harm to the participants. The CHR may also stop a clinical trial if there is clear evidence that the new intervention is effective, in order to make it widely available.
NIH-supported clinical trials require data and safety monitoring. Some clinical trials, especially phase III clinical trials, use a Data and Safety Monitoring Board (DSMB). A DSMB is an independent committee made up of statisticians, physicians, and patient advocates. The DSMB ensures that the risks of participation are as small as possible, makes sure the data are complete, and stops a trial if safety concerns arise or when the trial’s objectives have been met.
Note: Some of the information above was reproduced or adapted from desciptions on the websites of the National Cancer Institute (NCI) www.cancer.gov.