Clinical trial investigators play an important role in the development of products to combat disease, treat chronic and degenerative diseases, and improve the health of people around the world. The rapid development of new drugs, therapies and devices has dramatically increased the number of clinical trials required to properly evaluate them.
How to Become a Principal Investigator?
A Principal Investigator (PI) is the physician who leads the conduct of a clinical trial. The leadership role of the PI helps create the foundation of a successful clinical trial. The doctor who chooses to be a PI can offer his/her patients the possibility of receiving unapproved yet promising treatments, while assisting drug companies to evaluate the efficacy and safety of these treatments.
The PI is responsible for all clinical research activities at the center. The FDA mandates the PI to sign form 1572 that outlines the specific responsibilities a doctor must accept as leader of a clinical investigation. These responsibilities are defined as "Good Clinical Practice" (GCP). GCP is outlined in the Code of Federal Regulations (CFR) in sections 50, 56, 312, and 314. Please refer to the link below for more information about GCP.
To successfully run a clinical trial, certain ancillary staff are typically required to support the PI. Most clinical trials employ a study coordinator, a clinically-oriented individual who is involved in the daily operations of a study mandated by a protocol under the supervision of the PI. This person will often schedule patients, perform minor assessments and laboratory work (depending on level of clinical skills), and organize the data for transfer into Case Report Forms (CRF). CRFs are the official records that drug companies use to house the data collected by the Investigator. It is critical that the information contained in a CRF be accurate, as it is the final information used by statisticians to analyze the safety and efficacy of an investigational medication. As a PI, your responsibilities are two-fold: to assure that your patients receive the best medical care, and to assure that all study-related activities follow the FDA guidelines of GCP
Resources for Conducting Clinical Trials:
Conducting clinical trials requires a number of resources. The more resources a physician can provide, the more likely he/she will be invited to participate in a study. Here are some of the most common resources:
The PI and ancillary study staff should be available to the sponsor company to review study issues and answer pertinent study related questions.
How to Become Involved in Clinical Trials?
There are many avenues by which physicians may enter the clinical research field.
It is important to be versed in the regulatory requirements involved in the conduct of clinical trials. Classes and seminars are offered by organizations like Drug Information Association (DIA), Association of Clinical Research Professionals (ACRP), and Barnett International.
Becoming a Principal Investigator
Ocean Blue Medical Research Center is always seeking talented experienced physicians to become Principal Investigators. We encourage physicians who are interested in clinical research to join forces with Ocean Blue Medical Research Center to read the information posted in the Clinical Trials section to look for the therapeutic areas that that may be of your interest.
You may fill out the "Investigator Application Form" in this page and a staff member will arrange with you a visit to our office and assess staff experience and availability, and assess overall ability to successfully conduct the clinical investigation effectively. Based upon the results of the meeting, you will be notified in writing about our final decision.
Working as a Principal Investigator for Ocean Blue Medical Research Center is an exciting endeavor. We look forward to hearing from you soon.