What are clinical studies?
Clinical studies are research studies where participants volunteer in the testing and development of new treatments and medications for diseases and conditions. Clinical studies (or trials) are monitored by both the National Institutes of Health and the U.S. Food and Drug Administration.
Will I be compensated?
In nearly all of our trials, CTCR compensates study participants for their time and travel. There are standard compensation rates for the participant's time. Participants will also receive medication, lab work and exams at no-charge.
What should I expect as a participant in a clinical study?
Study participants undergo an intervention in order to evaluate its impact on their health. An intervention can be a drug, a device, a diagnostic tool, a genetic test, a new prevention method, or a new use for an existing medication.
Is my participation confidential?
Yes. CTCR strictly follows all HIPAA guidelines, meaning that all participant information including medical, history of illness, personal and any study results is confidential and protected.
Who decides if I am eligible for a clinical trial?
Researchers have two sets of criteria for any given study: inclusion and exclusion. Inclusion criteria are characteristics that a participant must have in order to take part in the study. Exclusion criteria are characteristics that a participant must not have if they wish to be a part of the study.
How long do the studies last?
Each study varies in length. If you qualify for the study, you will be informed of how long it will last.
How long is each office visit?
The office visit for each study may vary in length. The first visit often consists of an initial assessment, so it will generally be a longer visit. Subsequent visits may run from a few minutes to an hour.
Who will be overseeing my medical treatment?
Our staff members have years of clinical research experience. They are overseen by Dr. Cynthia Brinson, who is world-renowned in her field.
What should I expect from the clinical study team?
Our team will provide you with a thorough explanation about the clinical trial, answer any questions and address all concerns you may have. You will be given an informed consent form to review and sign to verify your understanding of the study, its potential risks and benefits, and the schedule and length of the study. You will also undergo an evaluation and receive a diagnosis from the study doctor.
Who decides what intervention I will receive during a clinical study?
Some clinical studies test an investigational drug against a placebo, which looks like the drug but doesn’t contain any active ingredients. Other studies may test two different drugs in order to determine the one that is most effective. Participants are randomly assigned the drugs or placebo by a computer – our research team has no say in the assignments.
Does it cost me to participate in a clinical trial?
No. All medical care, tests and medications related to the clinical study are provided at no charge.
What if I want to leave a clinical trial?
Participants are allowed to leave a study at any point. The signed informed consent document does not force you to remain in a trial. We may offer suggestions about how to leave the trial, especially if the trial medication should be withdrawn gradually, but you have the final decision.
What safeguards are in place to protect me?
Following federal law, we make every effort to keep you safe throughout your participation in one of our studies. Protective measures include:
- A written examination about the content of clinical research and ethical responsibility of the researchers.
- Preclinical studies showing the safety and effectiveness of the new investigational treatment in laboratory animal tests.
- Use of strict protocol, which is never deviated from during the trial.
- Informed consent, which is a written description of all the information that you will need to make an informed decision about joining a clinical trial.
What happens once I’m scheduled for a screening appointment?
Each study has its own requirements, but the following are general tips when preparing for your screening visit:
• Do not drink alcohol approximately 48 hours before your appointment.
• Do not ingest poppy seeds approximately 7 days before your appointment.
• Do not eat approximately 8 to 12 hours before your appointment (time varies for each study).
• Do not participate in strenuous exercise such as weightlifting or running for 2 to 3 days before you appointment.
• Do not stop taking any prescribed medications without your doctor’s approval.
• Do not bring anyone to your screening appointment. In order to protect the privacy of all participants, family, friends and children are NOT allowed in with you.
• Bring a valid photo ID with you, such as a driver’s license or passport.
If you are unsure about anything, please call our recruitment team at 512-480-9660.