GTL MEDICAL & RESEARCH Group

 What is a clinical trial?

A clinical trial is a type of research that studies a test or treatment given to people. Clinical trials study how safe and helpful tests and treatments are. When found to be safe and helpful, they may become tomorrow’s standard of care. Clinical trials are carefully designed, reviewed, and completed. Clinical trials are highly regulated by agencies/institutions such as the FDA and Institutional Review Boards. Clinical trials are carefully designed by Sponsors (government agencies, pharmaceutical (drug) companies, and non-profit organizations) and conducted by highly qualified medical personnel. 

What are some of the risks and benefits of clinical trials?

Benefits:

• You may get a new treatment for a disease before it is available to everyone.
• You play a more active role in your own health care.
• Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
• You may have the chance to help others get a better treatment for their health problems in the future.
• You may be able to get information about support groups and resources

Risks:

• The new treatment may cause serious side effects or be uncomfortable.
• The new treatment may not work, or it may not be better than the standard treatment.
• You may NOT be part of the treatment group (or experimental group) that gets the new treatment—for example, a new drug or device. Instead, you may be part of the control group, which means you get the standard treatment or a no-treatment placebo.
• The clinical trial could inconvenience you. For example, medical appointments could take a lot of time. You might need to travel to the study site several times or stay in the hospital

Am I given all the information before participating?

Yes. The informed consent form must describe the study in full, including:

• The trial’s purpose,
• What’s required of you,
• The risks and benefits,
• Protection of your privacy,
• Coverage of costs, and
• Other options for care.

 Do I have to complete the trial until the end?

No. You can drop out at any time for any reason. Participation is completely voluntary

 Is my health information protected?

Yes. We adhere to The Health Insurance Portability and Accountability Act (HIPAA)

 What is expected of me?

As a participant, you may be asked to attend study-related visits at our clinical site.  While in the trial, your health and welfare will be continually monitored. There is no cost for you to participate, and there is no need for health insurance.  In exchange for your participation, you may be compensated for your time and travel. Compensation varies by studies and overall study requirements. 

Do I always receive the study medicine/treatment ?

No. Depending on the study, a participant may randomly receive a placebo treatment. Placebos are harmless, inactive substances made to look like the real medicine used in the clinical trial. Placebos allow the investigators to learn whether the medicine being given works better or no better than ordinary treatment. In many studies, there are successive time periods, with either the placebo or the real medicine. In order not to introduce bias, the patient, and sometimes the staff, are not told when or what the changes are. If a placebo is part of a study, you will always be informed in the consent form given to you before you agree to take part in the study. When you read the consent form, be sure that you understand what research approach is being used in the study you are entering.

 What happens to me when the clinical trial is over?

You will continue to receive care from your physician/specialist. You may be able to stay continue the trial by participating in a study extension, but this doesn’t happen often. 

 Do I need have medical insurance to participate?

No, medical insurance is not required. Study participants will receive study-related medical examinations and study-related medication at no cost. Eligible participants may receive compensation for their time and travel. 

Will I be compensated for participating in a Clinical Trial?

Yes. In nearly all of our trials, we will reimburse you a flat fee for your travel expense for each office visit. The reimbursement rate varies per study and will be discussed with you in detail on your visit to the office.

Where can I get more information about research studies?

There are several organizations that offer information about research studies. Here are a few:

ClinicalTrials.gov  www.clinicaltrials.gov

CenterWatch  www.centerwatch.com

Center for Information & Study on Clinical Research Participation (CISCRP) www.ciscrp.org 

National Institutes of Health  https://www.nih.gov/health-information/nih-clinical-research-trials-you

U.S. Food and Drug Administration  https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.