What to Expect as a Clinical Trial Volunteer
Clinical research studies measure the effectiveness and safety of medications or treatments. All studies are conducted under the strict regulation of the Food and Drug Administration (FDA) and a sponsoring pharmaceutical company or other sponsoring entity. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.
You Are Essential to Our Success
Study volunteers help us to gather important information in the development of future treatments that might manage, cure, or even prevent diseases.
If you are interested in joining a study, please contact us to begin the process.
Our staff will contact you for an interview to try to match you with one of our studies. If you qualify, we will make an appointment for an in-depth screening interview and medical evaluation. During screening, you will receive a top-quality medical evaluation that may include a physical examination, laboratory tests, and/or other medical tests.
The Study Participation Process — From Start to Finish
Participating is a simple, straightforward process we know you’ll find informative and rewarding.
- Screening Appointment
- Confirmation Call
- Baseline Visit
- Study Visits
- End of Study
Once you express interest, the doctor or study staff will call you and discuss the study details with you. If you are still interested in participating you will be scheduled for a screening appointment.
This appointment is for both you and our research team to gather important information. Please allow 1 to 2 hours for this visit.*
Plan ahead and write down possible questions to ask (a helpful tip not just for the screening, but throughout the entire study). You also may want to ask a friend or relative to come along for support and to confirm what was discussed on both sides.
After the details and procedures are explained to you in detail, an informed consent process will take place at the screening visit. All clinical studies are different, so the exact procedures performed at your screening visit will vary – even if you’ve volunteered with us before.
Once you sign the informed consent document and agree to participate in the study, the study coordinator will complete the remaining screening procedures. This typically includes obtaining a blood and urine sample, vital signs, a complete medical history and a medication check.
Once your screening tests are in and the doctor has reviewed your results along with your medical history, the doctor will then determine your qualification to participate. The study coordinator will call you and inform you of this decision. If you DO qualify, you will be scheduled for your baseline visit. If you DO NOT qualify, we thank you for your time and interest, and no other visits are required. (Although you are welcome and invited to apply for future studies. You never know which study will be the right fit!)
This is your first official study visit. At this visit, you are usually dispensed the study drug and given directions on dosage, documentation of dosing and other instructions. You may also have labs drawn or other procedures performed. During this visit, you and the study coordinator will also set up your visit schedule so you understand when you need to come back into the office for further study check-ins.*
Studies vary in length. Some studies may only last a few weeks or months; others may last a few years. The length of your study determines the number of study visits you will have.
Here is what you can expect:
- In the beginning of a study the visits are usually more frequent – sometimes as often as every two weeks.
- As the study progresses, you’ll visit less frequently. For a long-term study, every three to six months is common.
- At each visit, you will need to bring your study medication and any diaries you were asked to fill out. The study coordinator will count your medication and dispense more medication to last through the next visit.
- The coordinator may also take a blood and/or urine sample and obtain vital signs, an electrocardiogram or other procedure.*
Your coordinator and physician are always available to take your calls or see you between study visits if needed. Please feel free to reach out to either resource if you have questions or are experiencing any side effects. In most cases, you can be seen in the office within one business day.
End of Study
At your last study visit, all unused medication will be collected and you will not receive any more. Exams and tests that are very similar to the one you did at the screening appointment will be performed. In order to continue your follow-up care, the coordinator will schedule a regular office visit for you with your physician in the next few months, aligned with your usual treatment schedule.
Clinical trials cannot accept every person who applies simply because they want to volunteer. Volunteering for a study is not like working on an event or campaign or at your child’s school.
Each trial has a strict protocol that we must follow to determine who may participate. Eligibility criteria are intended to protect the integrity of the trial. But equally important, they prevent volunteers from getting treatment that might harm rather than help them. Your safety is always our primary concern.
Eligibility criteria might include:
- Your overall health
- Body mass index (BMI)
- Skin type
- Results of medical tests
- Medications you are taking
- Any other health conditions
- Whether you have the specific condition being studied
- Other treatments you may have had
- How long it has been since you were last treated
If you meet the eligibility criteria for a clinical trial and choose to join, you will receive continual medical supervision for the entire time you are using the medication or treatment being studied.
All examinations, tests, and medications or treatments are provided to you at no cost. Insurance coverage is not required to participate in any Wake Research study.