Do You Want to Participate in a Hepatitis-C Clinical Trial?
A person living with Hepatitis C could have many reasons for participating in a clinical study. However, making the decision to be a subject in a trial is far from simple. Before deciding to sign up, make certain that you have all the facts. Understanding the pros and cons involved can help a person make this important decision.
What is a Clinical Trial?
A clinical trial is a research study using humans to answer specific health questions. When conducted carefully and thoroughly, clinical trials are the safest and fastest way to find effective treatments. Clinical trials for Hepatitis C could span many purposes, including:
- Finding ways to prevent the virus from proliferating
- Testing vaccines to protect someone from becoming infected
- Improving the existing treatment
- Testing a new treatment
- Investigating options for improving quality of life
Each clinical trial has its own protocol such as:
- What types of patients may enter the study
- What the schedule of tests and procedures are
- What drugs and specific dosages are administered
- The length of the study
- How the outcomes will be measured
These criteria help to reduce the amount of variation in the study without threatening the scientific integrity of the trial. Every protocol is designed to remove medical variations that might complicate analyzing the results. As a rule, each person participating in the study must agree to the rules set out by the protocol.
To see if it works as well or better, clinical trials for Hepatitis C often compare a new product or therapy to the current standard of treatment. In a blinded study, a participant is randomly assigned to one of three groups – and not informed of which group they were assigned to. In general the categories include those who:
- Receive the product being tested
- Receive the existing, approved therapy
- Receive a placebo (a product such as a sugar pill that has no therapeutic action yet looks like the product being tested)
However, placebos are rarely used in Hepatitis C trials. This is because participants with serious illness are typically afforded some kind of assumed effective therapy.
Why Volunteer for a Clinical Trial?
Since clinical trials are the only way to test new ways to fight Hepatitis C, participating puts you on the cutting edge of medicine. Typically, people with Hepatitis C enroll in a study because they have already exhausted their treatment options. Either categorized as a non-responder to pegylated interferon therapy or unable to tolerate the current therapy’s side effects, clinical trials may provide additional hope.
It is important to realize that not everyone who applies for a clinical trial will be accepted. Volunteers could be excluded based on:
- the eligibility criteria
- the number of participants needed
- any number of additional complicating factors
If interested in a clinical trial, you should learn as much as possible about it. In addition to understanding what happens during the trial, the type of health care received and any costs involved, it is important to feel comfortable discussing your concerns with the facilitators of the trial.
Pro and Con Balancing
By weighing the potential benefits against the possible risks, the decision to volunteer in a study can be clarified. Benefits to being a trial participant may include:
- being actively involved in your own health care
- gaining access to potentially new research treatments
- receiving expert medical care since the investigators are likely to be Hepatitis C specialists
- helping others by contributing to medical research
It is also important to consider both the known and unknown risks. The hazards of participating in a clinical trial may include receiving ineffective treatment, suffering from serious or life-threatening side effects or even being overwhelmed by the time investment required for the study.
An additional consideration is whether or not medical care will continue after the trial’s conclusion. Some possible questions to ask include:
- If there are side effects that linger beyond the time of the trial, will the trial’s healthcare team offer you any support?
- If the treatment was beneficial, will it be continued after the trial is over?
Finding a Hepatitis C Trial
Clinical trials can be sponsored by an organization such as a pharmaceutical company, a federal agency (such as the National Institutes of Health or Veterans Administration) or an individual (such as a physician or health care provider). Determined by the sponsor, trial locations generally are at universities, medical centers, clinics, doctor’s offices, hospitals and other research sites.
You can find information about clinical trials currently being conducted by searching www.clinicaltrials.gov. This website is updated regularly and offers information on each trial’s purpose, who is eligible to participate, locations and phone numbers to call for more information. As of late March 2008, a search on this website revealed 184 interventional trials currently recruiting or about to recruit volunteers for a Hepatitis C study. Once on this site, there is an option to refine your search using various parameters, such as location of study, participant age range, conditions included and the intervention being studied. Since there is often a long list of eligibility criteria, make certain that you are a match before proceeding with an inquiry.
Participating in a clinical study is not for everyone. Taking part in an as yet, unproven therapy is frightening for some and exciting for others. However, being thorough in your evaluation of any clinical trial will help you make this potentially life-changing decision. Especially for those who feel as if they’ve run out of Hepatitis C treatment options, enrolling in a clinical trial can offer the right person another chance at returning to health.
http://clinicalcenter.nih.gov, Are Clinical Studies for You?, National Institutes of Health, 2008.
www.clinicaltrials.gov, Search for Clinical Trials, US National Institutes of Health, 2008.
www.brightsurf.com, Hospitals that participate in clinical trials may provide better patient care, Journal of the American Medical Association, March 2008.
www.fda.gov, Basic Questions and Answers about Clinical Trials, US Food and Drug Administration, 2008.