Participating in Clinical Trials
Should I Join a Clinical Trial?
Many Trials Don’t Include Older Adults
The results of clinical trials can lead to new treatments for many diseases such as Alzheimer's disease, heart disease, various types of cancers, stroke, and diabetes. Older adults are more likely to be affected by these diseases, yet many clinical trials for these and other diseases often do not include older adults.
There are many reasons a trial may not include older adults. Researchers may worry that the treatment won't work as well for them, or there may be severe side effects that could have an effect on their quality of life.
Also, many older people may have several health problems at the same time such as diabetes, high blood pressure, or heart disease, which might affect trial results.
Other reasons may include a lack of support by friends and family, costs of care, and difficulty getting to health care centers where many trials take place.
More Older Participants Are Needed
Yet, clinical trials need more older participants so that researchers can better learn how potential new drugs, therapies, medical devices, or tests may work in older people.
Although older adults take more medicine than any other group, they are often not a part of experimental drug trials. As people age, their bodies absorb drugs differently. Older adults may need different dosages or have different side effects than younger people. If there are not enough older people enrolled in a drug trial, researchers may not get the information they need to develop appropriate treatments for older people.
For more on older adults and medicines go to Taking Medicines at http://nihseniorhealth.gov/takingmedicines/toc.html.
However, you don't have to be sick to be part of a trial. Trials need healthy people of all ages, as well as, people with various diseases or conditions. Many participants in clinical trials feel they get more medical attention, and they are helping themselves and others to live longer and healthier lives.
Please Keep in Mind
But clinical trials involve risks, just as routine medical care and the activities of daily living. When weighing the risks of research, you should consider two important factors:
- the degree of harm that could result from participating in the study, and
- the chances of any harm occurring.
Most clinical studies pose the risk of minor discomfort, which lasts only a short time. However, some study participants experience complications that require medical attention. In rare cases, participants have been seriously injured or have died of complications resulting from their participation in trials of experimental therapies.
If you are thinking of volunteering, talk with your doctor and the research team about whether a clinical trial is a good option or not in your situation.
Questions to Ask Yourself
Be sure to ask yourself these questions before making your decision.
- Have I gotten all the facts?
- Have I talked to my health care provider about my health condition?
- Do I know how my participation in the clinical trial will affect my daily life and activities?
- Am I able to get to the research site for appointments?
- Will it cost me anything?
- Am I willing to take the chance that I won't get the experimental product? Remember, you can't choose the group where you'll be placed. So there is a chance you will be in the placebo or standard treatment group.
- Can I fulfill my responsibilities, such as following the research team's instructions, taking medications on time, and completing logs or questionnaires?
Take time to think about what the research team told you and review the informed consent document at home. Read it as many times as you need. Discuss it with family, friends, your doctor, or other health care professionals.
If You Agree to Participate
After getting the facts about the trial, and if you agree to participate, the research team will give you the informed consent document. It describes the trial and explains your rights and responsibilities as a participant. If there is anything you don't understand in the consent document, ask for a better explanation before signing it. Once you sign it, remember that it is not a contract. You can leave the trial at any time for any reason.
Protecting Trial Participants
If you have concerns about your safety being protected by someone other than the research team, there are outside organizations that protect trial participants. They will stop a trial if they find that the experimental treatment is harming the participants or not having any effect. These organizations include Institutional Review Boards and Data and Safety Monitoring Committees.
Institutional Review Boards. Before starting a trial, researchers must get permission from their organization's Institutional Review Board or IRB. IRB members are independent of the study and do not have an interest in how it turns out. The IRB reviews the trial's protocol, or study plan, to look for possible risks to human subjects.
Data and Safety Monitoring Committees are independent of the study and look at data collected during studies comparing different drugs. They pay special attention to treatment trials for life threatening diseases. If a committee finds the experimental product is harming participants or is not working, it will stop the study.
Clinical trials can be stopped any time in any phase of testing if
- early results show the experimental product works much better than the others. In these cases, researchers offer the experimental product to the control group.
- the study finds no difference between the control group and experimental group, so further testing is useless.
- the Institutional Review Board or the Data and Safety Monitoring Committee find a problem with the way the researchers are running the trial.
- there are too many dangerous side effects.
Learning about New Developments
During the trial, the research team may discover new information that could affect your health or change your mind about staying in the study. They will give you this information and may ask you to sign a new informed consent document. Of course, you are free to leave the study if this information makes you uneasy about continuing.
To search for a clinical trial for you, go to http://clinicaltrials.gov.