|
 Participation in a clinical trial is an important personal decision. The following frequently asked questions provide detailed information about clinical trials. It may be useful for your physician, research team, family members, and friends about deciding to join a trial.
WHAT IS A CLINICAL TRIAL?
A clinical trial (clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
WHY PARTICIPATE IN A TRIAL?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
WHO CAN PARTICIPATE?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria." These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. Inclusion and exclusion criteria are not used to reject people personally. The criteria are used to identify appropriate participants and keep them safe. Criteria help ensure that researchers will be able to answer the questions they plan to study.
WHAT HAPPENS?
The clinical trial process depends on the kind of trial being conducted. The research team consists of doctors, nurses, research assistants, and other health care professionals. The team checks the health of the participant at the beginning of the trial, gives specific instructions for participating in the trial, monitors the participant carefully during the trial, and stays in touch after the trial is completed. Some clinical trials involve more tests and doctor visits then the participant would normally have for an illness or condition. For all types of trials, the participant normally works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
WHAT IS INFORMED CONSENT?
This is the process of learning the key facts about a clinical trial before deciding whether or not to participate. To help a patient decide whether of not to participate, the doctors and research team involved in the trial explain the details of the study. 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. Informed consent is not a contract, and the participant may withdraw from the trial at any time with written withdrawl.
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 approach for eligible participants to:
1. Play an active role in their health care.
2. Gain access to new research treatments before they are widely available.
3. Obtain medical care at leading health care facilities during the trial.
4. Help others by contributing to medical research.
Risks
1. There may be unpleasant, serious, or even life-threatening side effects to treatment.
2. The treatment may not be effectie for the participant.
3. 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.
WHAT ARE SIDE EFFECTS AND BENEFITS?
Side effects are any undesired actions or effects of drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, increased pain, no relief of previous symptoms, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
HOW IS THE SAFETY OF THE PARTICIPANT PROTECTED?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addtion, most clinical research is federally regulated with built in safeguards to protect the participants. The trials follow a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Participant's names will remain secret and will not be mentioned in these reports.
DOES A PATIENT PARTICIPANT CONTINUE TO WORK WITH A PRIMARY HEALTH CARE PROVIDER WHILE IN A TRIAL?
YES! Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care.
CAN A PATIENT 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, in writign and the reasons for leaving the study.
WHERE DO THE IDEAS FOR TRIALS COME FROM?
Ideas for studies usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about a new treatment, its risks, and how well it may or may not work.
WHO SPONSORS CLINICAL TRIALS?
Trials are sponsored or funded by a variety or organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, implant companies, along with federal agencies such as the National Institute of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations such as hospitals, universities, doctors' offices, or community clinics.
|
