Patients
If you are a patient and considering participation in a clinical trial or study, you are not alone. Medications and medical devices must go through a clinical research process prior to FDA granted approval, which means all medications currently dispensed to the general public have had patient volunteers participate in studies, in order to advance medicine and provide a better quality of life for patients in the future. Your physician will determine whether you are candidate for a study and if so, explain what is being tested in the study, whether there are potential side effects, the length of the study and next steps to enroll in the study. Study participants are compensated for their time, travel, and mileage to help research scientists in testing the safety and efficacy of new vaccines, medications, and devices.

FAQs

Will I be compensated?

Yes, study participants are compensated for their participation in the study with either a stipend or travel reimbursement, or both on each visit.

What is the process? How do I get started?

To participate in a trial managed by Provision Center for Biomedical Research, patients must first become established with our principal investigator’s practice (the Principal Investigator is the physician who assumes full responsibility for a research study). If patients are not already established with the physician’s practice, this may be done through the specific practice’s referral process. If you have questions regarding eligibility for a study prior to wanting to establish with our physicians, you may reach out to our Study Coordinator for a brief study overview and review of inclusion/exclusion criteria. At this time the Study Coordinator can also review the referral process for establishing with the necessary medical practice to advance to the next steps.

What to expect during the screening appointment?

During the screening process you can expect a multitude of activities such as a review of medical history and medications, questionnaires, and potentially imaging and other diagnostic testing, blood draw, and/or a physical exam. The screening period can last between 30-60 days over the course of multiple visits in order to complete all necessary requirements.

  • Neurology studies may require memory testing and a lumbar puncture for spinal fluid analysis.
  • Pulmonology studies may require a right heart catheterization, ECHO, pulmonary function test, and 6-minute walk test.
  • Medical Oncology studies may require a biopsy or a repeated biopsy if it was not completed within the allotted time-period. Lung cancer studies may require a pulmonary function test.
How long will I need to participate in the study?

Each study varies, some may last three months, some may last a year, and some may have a follow-up study that leads to another study, extending the full commitment to another year. Your research coordinator will explain the length of time for the study you are interested in.

Will my health be evaluated during each visit?

Yes, you will meet with your Study Coordinator at each visit who will talk with you about the study drug and how it is affecting you. In addition, physical exams will be conducted throughout the study, but not on every visit. A Study Coordinator will ask a physician to evaluate the patient, should the patient experience any adverse event from the study drug.

Can I participate in more than one study at a time?

Study participants are limited to one study at a time; however, if you fail a screening for one study, you are welcome to consent and screen for another approved study by your physician.

Who can I contact if I have a question or need assistance?

Your clinical research coordinator is available to answer any questions or address areas you may need assistance throughout the process.

Is my participation in the study voluntary?

Yes, while you signed a consent form to enroll in the study, your participation is voluntary, and you may remove yourself from the trial at any time for any reason.

 

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Should you have further questions or need information on a study, please Contact Us.

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