What is clinical research?
Clinical research is a medical research involving people. It is a branch of science that helps us gain knowledge about the disease progression, new medical drugs, procedures or devices.
There are two types of clinical research:
- Clinical trial is an interventional study. It tests the safety and efficacy of the new medical drugs, procedures, or devices
- Observational study only observes people and collects data from them. It does not test any new drug or device. Such a study only gathers information of how a disease is progressing in different people.
How safe are these trials?
Before testing the drug on humans, it undergoes a preclinical phase. During this phase, the drug undergoes testing for safety and efficacy on lab animals.
Once the drug completes a preclinical phase, before further testing on humans, the sponsor needs to get an Interventional Review Board’s (IRB) approval for the study design and the benefit to risk ratio. The IRB reviews the study design with patient safety as its only priority. Only after IRB’s approval, the drug enters the clinical trial phase. Throughout the study duration, the IRB, the sponsor, and your study team communicate constantly to monitor patient safety.
The clinical trial has 4 phases:
Phase 1 enrolls healthy volunteers to test for drug dose safety.
Phase 2 enrolls about 100-300 target population to test safety and efficacy of the drug.
Phase 3 enrolls 300-1000 target population for final testing.
Phase 4 post-approval studies, collecting data on the long-term effect.
All these phases are strictly governed by the IRB and the FDA.
At any given point, patient safety is of utmost priority.
Is my information confidential?
Your information will be confidential. Once you are enrolled in the study you will receive a subject number. All the data collected from you will be associated only with that number. Your identity will not be revealed anywhere. If a study thinks your identity could be compromised then that information will be available to you in the informed consent form that you will sign before enrolling in the study.
Why is clinical research important?
Clinical research helps scientists get more information of about disease progression. Better knowledge and understanding of the disease will lead to development of better cure. Sometimes the current interventions would only help in slowing the progression of disease or help manage symptoms. In these circumstances, development of new drug to prevent the disease or cure the disease or even better management with less side-effects would be a break through.
Why should I participate in the research study?
- By participating in the study, you will be helping scientist develop new intervention that will help people like you.
- Sometimes, the current medications are not helping you enough. So by participating in the study you would be able to explore the drugs that could potentially help you in the future.
- Some just want to help the community.
So, what’s your reason going to be?
Feel free to contact our research team and learn more about the clinical studies.
Phone number: 937-224-8200 ext. 105
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