 FAQs |
What is Clinical Research? |
Clinical research is one of the ways the medical world looks for better or new ways of treating illness and disease.
The Food and Drug Administration (FDA)/ local regulatory authority require that all medications be thoroughly tested for safety and effectiveness before they can be prescribed by your doctor. A clinical trial is a partnership between doctors, participants, study sponsors, and the FDA/ local regulatory authority to study the effectiveness of a study medication. In a clinical trial, information is collected from participants who are treated with study medications and then reported to the sponsor and FDA/ local regulatory authority. |
Why people participating in Clinical Research? |
Every day, people from all over the world participate in clinical trials to help themselves and others improve their quality of life.
Every clinical trial attempts to answer specific research questions. To do this, each trial has certain requirements about a participant’s medication, age, and current and past health history. You must meet the requirements of a particular trial to be an eligible participant. |
What happens during a clinical trial? |
Participating in a clinical trial is much like a regular visit to a doctor’s office, hospital, or medical clinic. Participants are treated professionally and with care.
During a clinical trial, study medication is administered. Also, tests and procedures are performed according to a research protocol, which has detailed guidelines that the research staff and physicians follow. The research protocol is designed by the study sponsor to measure the effectiveness and safety of the study medication or procedures. |
Are Clinical Trials Safe? |
Participant safety is the number one priority of any study.
Each participant is given a consent form to sign that describes the most common risks for the medication being studied and the potential benefits of participating in the study. You will be able to discuss the informed consent with the research staff. They will help you fully understand the risks and potential benefits of participating in the study and your rights as a research participant. Your medical condition will be monitored throughout the study by experienced research staff and physicians. Participation in a clinical trial is voluntary, and you can withdraw at any time. |
Why should I Participate? |
As a qualified participant for clinical trials:
- You may be benefiting your future and the future of others by helping with the evaluation of new medications.
- All visits and procedures related to the study are free of charge. Those may include physical examinations, doctor visits, dietary counseling, study medications, and laboratory tests.
- You may have the opportunity to receive a new research medication for the treatment of your condition.
You may learn more about your condition or disease and the latest treatments available. |
What If I already have a Doctor? |
You should continue to see your own doctor for all non-study related medical matters and to discuss your participation in the clinical trial.
At your request, our staff can keep your doctor informed about your participation in the study. |
Can a participant leave a clinical trial after it has begun? |
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study. |
What is Informed Consent? |
Consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time |
What are the benefits and risks of participating in a clinical trial? |
Benefits
Clinical trials that are well-designed and well-executed are the best treatment approach for eligible participants to:
- Play an active role in their own health care. Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
Risks
There are risks to participating in a clinical trial.
- There may be unpleasant, serious or even life-threatening side effects to treatment.
- The treatment may not be effective for the participant.
The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements. |
Do I get paid for participating? |
| Many research studies compensate participants to help offset any out-of-pocket expenses that may be incurred during participation (e.g., parking, travel, lodging expenses, baby-sitting costs). The amount of compensation is determined by the sponsor and reviewed and approved by an Institutional Review Board/Independent Ethics Committee. |
