Clinical trial faqs
Clinical trials are an important tool in understanding cancer and developing cancer treatments. Before a drug is approved to treat cancer in humans, it must undergo rigorous testing that begins in a research lab before making its way to clinical trial testing. Below are answers to some commonly asked questions about clinical trials.
What is a clinical trial?
According to the National Institutes of Health, a clinical trial is a research study in which one or more human subjects are assigned to one or more interventions, often a treatment. The purpose of a clinical trial is to evaluate the effects of those interventions on medical or behavioral outcomes.
Can i participate in a clinical trial if i am hiv positive?
Yes! In the past, PLWH were often excluded from clinical trials because of shorter life expectancies, fear of drug-to-drug interactions in patients on HAART, and concern for HIV progression. However, scientific data does not support these claims. Research has shown that PLWH have life expectancies similar to those of the general population when virally suppressed, and that they experience similar benefits from cancer treatments without a higher risk of adverse outcomes. It is safe for PLWH to enroll on cancer clinical trials unless there is a specific, evidence-based reason to exclude them. You can look at the inclusion and exclusion criteria sections of a clinical trial protocol to determine if a study is enrolling PLWH.
Will i receive a placebo or fake treatment?
In all clinical trials, the control group, or group that is being compared to the new intervention, must be equivalent to the standard of care for the disease being studied. That means if there is an effective therapy available that is usually given to patients with the disease, patients in the control group must receive that therapy. The only time patients in a control group are given a placebo drug is when there is no standard treatment for the disease.
What are the benefits of participating in a clinical trial?
You may receive treatments that are not yet available to the general public
Trials often require closer follow-up and medical care than is standard
You have the opportunity to be an active participant in your care
Information regarding support groups and resources is often available from the trial researchers
The information that is obtained from your participation can help others with the disease
What are the risks of participating in a clinical trial?
Participation may require frequent visits to the hospital and tests that are uncomfortable or invasive. Clinical trials are not always convenient, but make sure to address any issues or concerns you may have with your care team
You may be in the control group and not actually receive the intervention or treatment being studied. The control group may involve you getting another therapy that is the standard treatment, or a placebo if there is no standard treatment. However, you will not receive substandard or unequal care. In fact, if the new intervention or treatment is clearly more effective than the standard before the trial ends, the trial is stopped and all patients are given the new treatment
You may experience uncomfortable or even harmful side effects from the intervention. However, you will be carefully observed on the study for any side effects, and you will be treated for side effects if necessary
Uldrick TS, Ison G, Rudek MA, et al. Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research HIV Working Group. J Clin Oncol. 2017;35(33):3774-3780. doi:10.1200/JCO.2017.73.7338
National Cancer Institute Center for Cancer Research. (n.d.). FAQs - center for cancer research. Retrieved April 12, 2022, from https://ccr.cancer.gov/clinical-trials/patients/faq
U.S. Department of Health and Human Services. FAQs about clinical studies. NIH Clinical Center. Retrieved April 12, 2022, from https://clinicalcenter.nih.gov/participate/faqaboutcs.html
All data and information provided on www.cancerfreehiv.org comes from peer-reviewed sources. Publications from which data are obtained are listed at the bottom of figures or each page