What to Expect as a Clinical Trial Volunteer
Still not sure about the volunteering process? Learn more about how it works below:
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), an Institutional Review Board (IRB), and a sponsoring pharmaceutical company. 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. Please be sure and leave your best phone number(s) and email address so we can contact you as soon as possible.
Our staff will contact you for an interview to see if you might be a match for 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 Clinical Trial Process — From Start to Finish
Pre-Screening – The first thing that happens when you are contemplating participating in a clinical study is that 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.
Screening Appointment – After agreeing upon the details and procedures explained to you in the research study discussion, an informed consent process will take place at every screening visit. All clinical studies are different, so the exact procedures performed at a screening visit may vary. Once you have signed the informed consent document and agreed to participate in the study, the study coordinator will complete screening procedures such as obtaining a blood and urine sample, vital signs, a complete medical history and a medication check. Please allow 1 to 2 hours for this visit. (*)
Confirmation Phone Call – Once all of the results from the screening tests are in and the doctor has reviewed your results along with the information you provided to us regarding your medical history, the doctor will then make a decision regarding 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.
Baseline Visit – 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 visits. (*)
Study Visits – All studies vary in length. Some studies may only last a few weeks, 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 begin to expect in the early stages of a study in regards to the amount of visits you will be expected to make:
- Typically in the beginning of a study the visits are usually more frequent – sometimes as often as every two weeks.
- As the study progresses you can be seen less often – usually every three or six months.
At each of these visits you will need to bring your study medication and any diaries you were dispensed. The study coordinator will count your medication and dispense more medication to you. The coordinator could also take a blood and/or urine sample and obtain vital signs, an electrocardiogram or other procedure. (*)
End of Study – At your last study visit all medication will be collected and you will not receive any more medication from the study. Procedures that are very similar to the one you did at the screening appointment will be performed. In order to continue your care, the coordinator will usually schedule a regular office visit for you with your physician in the next few months according to your usual treatment schedule.
Between Visits – Your coordinator and physician are always available to take your calls or see you between study visits. 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.
(*) Every study is different and the actual length of the visit can vary considerably. Your study coordinator and/or doctor will give you more information at your screening visit in regards to the approximate length of each visit.
Not all clinical trials are right for all volunteers. Each trial has a protocol that we must follow to determine who may join the trial. These are called eligibility criteria and are intended to protect volunteers from getting treatment that might harm them.
Eligibility criteria might include:
- Your overall health
- Age and gender
- 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 the clinical trials for which we’re recruiting and choose to join, you will receive continual medical supervision for the entire time you are using the study medication or treatment. All examinations, tests, and medications or treatments are provided to you at no cost. Insurance coverage is not required to participate in a study.
First time as a volunteer?
Here’s some advice and additional info:
- Plan ahead and write down possible questions to ask.
- Ask a friend or relative to come along for support and to hear the responses to the questions.
- 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.
To view our current list of studies, click here.
If you would like to become a volunteer, click here.