If you want to play an active role in your health care, have access to the newest treatments before they are widely available, and help others by contributing to new research, then a clinical trial may be for you.
A clinical trial is a biomedical or health-related research study in human beings that follow a predefined study plan, commonly referred to as a “protocol.” A protocol describes what types of people may participate in the trial, as well as the schedule of tests, procedures, medications, and dosages, and the length of the study.
The clinical trial process depends on the kind of trial being conducted. The studies can be interventional, meaning a treatment or other intervention is introduced, monitored and its outcomes measured. Other studies can be observational, where participants are observed and outcomes are measured.
Some studies are looking for people with a particular condition, while other studies are seeking healthy participants. As a study participant, you will work with a research team who are investigating the treatment, intervention or specific behavior and its result regardless of which type of trial you are involved in.
Generally speaking, many clinical trials include a medical team of doctors and nurses as well as social workers and other health care professionals. Each study participant receives a health checkup at the beginning of the trial, and is given specific instructions for participating in the trial.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. Clinical trial participation is most successful when the study plan is carefully followed and there is frequent contact with the research staff. The team monitors the participant carefully during the trial, and stays in touch after the trial is completed.
If you have a current health condition being investigated, you will still need to maintain your regular medical appointments with your primary health care team. Most clinical trials provide short-term treatments but are not meant to replace your primary health care. Your primary physician works with the research team to ensure other medications or treatment won’t conflict with the study protocol or unknowingly cause adverse health risks.
There are benefits and risks each patient should consider before beginning any clinical trial. Benefits include having access to new treatments that could improve your health and quality of life or prolong your life. You may also receive a standard treatment along with expert healthcare during the trial at no cost to you.
Clinical trials follow strict scientific guidelines to ensure their safety, and care is taken that the risks don't outweigh potential benefits. However, patients should be aware that experimental treatments must be evaluated for both immediate and long-term side effects, so unpleasant, serious or life-threatening side effects could occur during your treatment.
There’s also a risk that a treatment may not work for you, and your participation could require trips to the study site, hospital stays, additional treatments or complex dosage requirements, and if your treatment is not free, your insurance may not cover all the costs of a clinical trial, according to the National Institutes of Health.
To help you decide whether or not to participate in a particular study, the doctors and nurses involved in the trial explain the details of the study so you can learn the key facts and know your possible benefits and risks. To learn more about a particular study, talk with the study coordinators, your primary physician and your insurer.
Clinical trials in more than 100 countries are looking for participants. To see if there is a trial you qualify for, try these free web sites:
• National Institutes of Health: http://clinicaltrials.gov/
• Search Clinical Trials: http://www.searchclinicaltrials.org/
• American Cancer Society Clinical Trials Matching Service: http://www.cancer.org/treatment/treatmentsandsideeffects/clinicaltrials/app/clinical-trials-matching-service/
• National Cancer Institute: www.cancer.gov/clinicaltrials/
• EmergingMed: http://www.emergingmed.com/
• CenterWatch: http://www.centerwatch.com/
• ClinicalConnection: http://www.clinicalconnection.com/
Lynette Summerill is an award-winning writer and Scuba enthusiast living in San Diego, CA with her husband and two beach loving dogs. In addition to writing about cancer-related issues for EmpowHER, her work has been seen in newspapers and magazines around the world.
Sources and Patient Information:
National Cancer Institute. Education Materials About Clinical Trials. Accessed online 28 February 2012 at: http://www.cancer.gov/clinicaltrials/education
National Institutes of Health. Understanding Clinical Trials. Accessed online 28 February 2012 at:
http://clinicaltrials.gov
Understanding Clinical Research. University of California San Diego Health Services. Accessed online 28 February 2012 at: http://ctri.ucsd.edu/community/understanding-clinical-research
Reviewed March 6, 2012
by Michele Blacksberg RN
Edited by Jody Smith