by Lisa Pacitto, Patient Services, CLINICA Medical Research
Chances are you or someone in your family relies on medication to treat a medical condition such as diabetes, high cholesterol, or heart disease. Maybe you or someone you know uses a medical device such as a blood glucose meter, a hearing aid, or a pacemaker to help improve the quality of life. Yet before these beneficial medicines and medical devices can be made available to you and those you love, they must first undergo extensive laboratory and clinical testing to assess their safety and effectiveness.
In 2003, more than 8 million Americans participated in clinical trials, of new drugs and new medical devices. Liz Taylor, Director of Clinical Trials at CLINICA Medical Research in Waltham, Massachusetts, stresses the importance of sound medical research, which helps develop new medicines and find new ways to deliver medicines more effectively.
"We are currently conducting research on a device similar to an asthma inhaler, that delivers insulin orally to people with diabetes. This new delivery system would offer an ease of use and comfort over injecting insulin, making it easier for people to take their medicines and positively affect their health," Taylor said.
Medical research is not only necessary to find treatments and cures for existing medical conditions, it is also crucial for the prevention of disease, such as the diabetes prevention study now under way at CLINICA Medical Research. Currently, diabetes afflicts approximately 18 million people in the U.S. and an estimated 16 million more people are on the verge of developing the disease.
People are motivated to participate in a research study by a desire to help find a cure for a particular disease, to better understand and treat their own disease, or to connect with people who have similar health issues.
If you have ever thought about participating in a research study, here are a few facts you should know before joining a clinical trial.
What are the benefits and risks of participating in a research study?
The benefits can include: access to new medications, expert medical care, medical tests and lab work free of charge. Risks are often minimal, but do vary depending upon the nature of the clinical trial. The purpose for the study, the study procedures, and any potential risks are detailed in a document called the Informed Consent. You need to read the Informed Consent carefully, as it clearly states what your involvement in the study will be.
Bring your questions and concerns up to the study physician and clinical staff as well as your own physician. You should never feel pressured to begin or remain in a study if you have unanswered questions or feel uncomfortable about study procedures.
Who should not participate in medical research?
People who have serious health risks or conditions, such as advanced heart disease or cancer are not typically allowed to join clinical studies, unless those are the conditions being studied, and even then, you should discuss the matter thoroughly with your physician. Other factors for not participating in a study include taking a medication that would interfere with the study drug or cause you to have a negative reaction; being scheduled for surgery before or during the study period; already participating in another clinical trial; and not being able to fulfill the study time commitment.
What types of research are there?
Medical focus groups and opinion surveys require little time and typically seek your opinion about medical devices or new product packaging. Researchers might ask you to evaluate a medical device such as a digital thermometer, wrist brace, or blood glucose meter. Studies of longer duration might involve the testing of a new drug, finding new uses for an existing medication, or comparing a medication to others already on the market.
What are the time commitments and costs?
Time commitments vary, depending upon the study, and can range from three hours to six months, one year, or several years. Typically, all procedures (physicals, EKGs, X-rays, blood work, etc.) associated with a clinical trial are provided free of charge.
Will I be compensated for my participation?
Most clinical trials provide a stipend to participants to compensate them for time and travel expenses. The amount of the stipend depends on the duration and complexity of the study, but generally stipends can run from $500 to $3,000.
What are my rights as a study participant?
Patients' rights and safety are protected by an Institutional Review Board (IRB). The IRB, composed of physicians and lay people, examines each study's protocol to ensure patients' rights and safety. The Informed Consent form also protects patients' rights by detailing all aspects of the study and letting participants know they have the right to leave a study at any time for any reason. Patient privacy is protected by the Health Insurance Portability and Accountability Act of 1996, also known as HIPAA. For more information on patients' right and privacy, visit the patients page on the CLINICA web site: www.trialcenter.com/patients.
How do I get involved in a research study?
Contact CLINICA Medical Research, Waltham, Massachusetts; telephone: (781)-647-7200, or visit our web site: www.trialcenter.com/research for more information and a listing of current research studies. You can also visit two "clearing house" websites: www.centerwatch.com or www.clinicaltrials.gov to find a clinical trial near you.