There are requirements that participants must meet (medication, lifestyle choices, stage of disease, etc).
You must meet stringent criteria to be a candidate.
Participation generally includes multiple office visits and additional time requirements from the volunteer.
Some potential volunteers are uneasy about anything that is “investigational”.
Why Should I Participate?
Study related medications and procedures are provided at no charge to the participant or their insurers. Participants are also evaluated by licensed, board certified clinicians at no charge.
There is usually a stipend paid to the participant to compensate for the additional time and travel of participation in the study. The actual stipend depends on the study but may range from $25 - $150 per visit. It is important to note that the amount of the stipend is relative to the requirements of the participant and not related to the risk of participation.
Participants are excited to be part of furthering cures and or treatments within medicine. Taking any medication has a risk but after finding the information, they decided the study was right for them. They also have a sense that they are helping others in a small way: If no one participates, new drugs are not available.
Some trials are device trials with no drug at all.
We greatly appreciate you and your contributions to furthering research so new medications may become available.
You will be provided with an Informed Consent Form (ICF) before we collect any data. This form has been reviewed by an Independent Ethics Review Board (IRB) that is overseen by the Food and Drug Administration (FDA).
The risks and benefits of participating in a trial vary widely between each trial and cannot be generally summarized. If you enroll into a trial, you will be informed of any changes to the risks and benefits as they become available as required by law. The principle Investigators and ASR staff will always be available to answer any questions you may have. We encourage you to ask questions at any time.
You will not be pressured to enroll in a study. You can take as much time as needed to discuss with your family or Primary Care Provider before participating.
Your information will be kept confidential. ASR is a HIPAA covered entity and complies with all local, state, and federal regulations. We will tell you what we are going to do with your information. If you no longer want us to use your information, simply let us know.
Compensation is provided by check after completing study “milestones”. When and how much you are paid and when is described in the Informed Consent Form (ICF).
Most clinical trials last from 6 months to 2 years, depending on the study. During this time, all study related activities (examinations, lab work, EKG’s, lung function tests, X-rays, study related medications, etc.) are provided at no charge to the volunteer.