What Is Clinical Research

Reinaldo Version, MD & Lead PI (28 years in research)

What Is Clinical Research

Because every clinical trial is designed to answer questions, each trial is managed differently. But, then the end goal is to determine if this drug is safe and effective to treat certain diseases. Clinical trials go through several phases to determine if the drug under study can be approved by the FDA for marketing.

Phases of a Clinical Trial

The FDA mandates that a new drug goes through a series of four types of clinical trials. As the drug moves through each phase, researchers learn more about a medication, including its risks and benefits.

Is the medication safe and what is the right dose?

Phase one trials involve small numbers of participants, often normal volunteers.

Does the new medication work and what are the side effects?

Phase two trials test the treatment or procedure on a larger number of participants. These participants usually have the condition or disease that the treatment is intended to remedy.

Is the new medication more effective than existing treatments?

Phase three trials have even more people enrolled. Some may get a placebo (a substance that has no medical effect) or an already approved treatment, so that the new medication can be compared to that treatment.

Is the new medication effective and safe over the long term?

Phase four happens after the treatment or procedure has been approved. Information about patients who are receiving the treatment is gathered and studied to see if any new information is seen when given to a large number of patients.

Garry L August, MD PI & Sub-Inv ( 31 years in research)

“Columbus Research & Wellness is a comprehensive research organization conducting, and overseeing research that is monitored and audited by CRO”s and Sponsors for the submission of new and novel drugs submitted to the FDA”

Is It Safe to Participate in Clinical Research?

Anthony Olofintuyi, MD PI & Sub-I ( 8 years in research)

AT CRWI we take every necessary step ensure that our patients are safe and that we are following all standards and guidelines regulated by our governing authorities. There are several steps in place to make sure clinical research is safe. First, it is regulated by the federal government. The IRB is a human protection agency and Human Subjects Research Protection Program at each study location has many safeguards built into each study to protect the safety and privacy of participants. Your participation in one of our studies are blinded and your privacy respected. We are required by law to follow rules that protect human experiences in a clinical trial. All studies must comply with the IRB and the FDA.

OUR TEAM

Reinaldo Version, MD Lead PI

Garry August, MD PI

Anthony Olofintuyi, MD PI

Jose Canedo, MD PI

Jagdish Sidhpura, MD PI

LaToya Benita Stephens Sub-Inv