*What is a Clinical Trial?
A Clinical Trial or Study is a process of testing of an investigational medicine, vaccine or medical device in a controlled environment. It may also involve researching new indications for an already approved medicine. The Trial is conducted in groups on human volunteers to answer specific health questions and test the effects of new medications, treatments, or devices.
Clinical Trials and the participants safety are closely monitored by the FDA and other regulatory agencies to help make new and advanced therapy options for disease available.
*Do I need to bring proof of insurance to study visits?
We do not ever file insurance, including Medicare or Medicaid
for study visits or procedures. The sponsoring pharmaceutical company pays for all the expenses for the work done as a part of the study and for study medications.
*What is the commitment to partcipate in a study?
Each study has a different time commitments. Depending upon the study, participants may be required to make 6-8 site visits on a recurring basis (monthly, bimonthly, quarterly). Some studies require the participant to stay at the site for 2-6 hours for different testings, for example blood samples, EKG's or pulmonary function (breathing) tests. These would be required at different time points withing the study. Studies can range from 3-4 weeks to 3-4 years.
*As a patient, are there any cost associated with being enrolled in a study?
At our reserch site, there is no charge to the patient for any office visit, procedure, lab work or for the study medication. Depending on the study, patients will be reimbursed for certain travel expenses.
*Will I stop seeing my primary care physician (PCP) if I am enrolled in a study?
No. We encourage all patients to continue seeing their PCPs as usual. We like to to notify the PCP about the study and keep them updated of any abnormal findings.
*Who can be in a clinical trial?
Healthy volunteers and volunteers with a speific condition are both required in the clinical trial process.
Trained clinicians review some personal information, current medications, and medical history to determine if a volunteer may qualify. Once preliminary criteria is met more testing is completed to ensure a volunteer is a good candidate for participation.
Qualified participants receive medication and care at no cost. Reimbursement for time and study related travel may also be available.
*How does my participation make a difference?
Patients volunteering to participate in clinical drug studies have the opportunity to get a better understanding of a disease and gain access to help develop new treatments that are not currently available.
By volunteering, participants are an important factor in the future of medicine allowing themselves and others with the same health issues to benefit from new and advanced therapy options.
Frequently Asked Questions