You do receive a small stipend as reimbursement for the time you spend participating and travel costs. The compensation amount varies between each study, but is generally over $30 per visit. There may be additional compensation for completing diary entries or other aspects of the study.
At your screening visit, you will get to know the study coordinator and learn more about the study. You are given time to read, ask questions, and sign the informed consent. The coordinator will gather information on your medical history, collect labs, and perform an EKG and drug screen. If everything comes back within acceptable ranges, then you will be scheduled for your next visit where you will be dispensed the study medication. Most studies have a 50/50 split of placebo to study medication. The studies performed at CMR are double-blind meaning both the participants and CMR do not know if you are receiving the investigational medication or the placebo.
You do not need insurance to participate in our studies. All aspects of the study are paid for by the sponsor (including labs, ECGs, and the study medication). There is no cost to participate.
Clinical trials are regulated for the safety and efficacy of the investigational medication. The Federal Government enforces strict regulations to ensure safety protocols are followed correctly. There is also an Institutional Review Board that approves each clinical trial’s protocol and plan to protect the safety of participants. Additionally, patients are monitored for adverse events and side effects of the medication. The studies are designed to ensure the safety of patients as much as possible. Before a medication reaches clinical trials, they are tested in laboratories and animals. Additionally, clinical trials are performed in phases. Phase 1 tests the medication in a small group of healthy participants to determine the safety of the medication. Phase 2 tests the effectiveness of the medication in a larger group of patients, while continuing to gather safety information. Phase 3 compares new treatments to the standard treatment to see how the new treatment compares. Phase 4 is performed after the new treatment is approved and on the market. This phase determines the long-term safety and effectiveness. Studies at CMR are Phases 2, 3, or 4.
Each study has a different time commitment depending on the study design. Studies can range from a few weeks to over a year. Studies differ on the regularity of the appointments - some require weekly or monthly visits, while others require visits only after dosing on the study medication. In general, the screening visit is the longest because it requires extensive medical history and questionnaires, while follow-up visits are shorter. However, this depends on the study as some have long visits throughout. The study coordinators would be happy to give you more specific information about the time commitment.
In most studies, patients have a 50/50 chance of receiving the placebo or the study medication. The studies are double-blind meaning neither the patient nor the CMR staff know which the patient receives. There are some other studies with a different distribution of investigational medications and placebo with different dosing. There are several studies with open label extension phases where free investigational drug is provided for up to a year.
A placebo is a pill or tablet that looks identical to the study medication, but does not have the therapeutic effect. It is used as the control to determine the efficacy of the study medication. The placebo is taken just like the investigational medication because in a double-blind study we do not know which is the placebo or the study medication.
Our office is located at 7501 College Blvd, Suite 100 in Overland Park, Kansas. If you have any questions about our location, please feel free to call us at (913) 381-7180.
If you do not have reliable transportation, our office can arrange an Uber pick-up service. Please notify your coordinator if this is something you need.