How to Choose Good Clinical Research Investigators

A clinical trial must be supervised by a qualified person in accordance with applicable regulations and clinical guidelines. These qualifications may vary depending on the disease or therapeutic treatment under investigation such as cancer research. One of the worst mistakes a sponsor can make is to hire someone who is not qualified to run the clinical trial. Such mistakes can be costly to the sponsor, participating patients and the clinical investigator. To avoid this problem, consider the following steps to select the right clinical trial investigator.

Instructions

• 1

  Look for someone working with the condition or indication under investigation. Consider the disease or therapeutic indication being investigated and the requirements for the person to treat the disease. For example, if the clinical trial calls for surgical intervention like inserting a stent, you would want to find a medical investigator who does this for a living, not a podiatrist or general practitioner.

• 2

  Use various resources. Perform an Internet database search to get the name of medical investigators interested in the disease you want to investigate. Ask colleagues for recommendations. You can also contact organizations that specialize in connecting sponsors with clinical trial investigators.

• 3

  Determine if the clinical investigator is interested in conducting your clinical trial by contacting him or her and giving them a brief synopsis of your study protocol.

• 4

  Verify eligibility. Request a copy of the current curriculum vitae (CV) and medical license, as applicable, of your candidate. Review the documents and determine if she has significant experience with the condition under investigation to perform the protocol requirements.

• 5

  Check for FDA Disciplinary Actions and Warning Letters. Compare the potential investigator's name and address against the FDA Disqualification and Debarment Lists and the U.S. Government Excluded Parties List System (EPLS). If the potential medical investigator's name appears on the list, verify that the name listed is the same person you're considering. If it is, find another investigator. Check out the FDA's Warning Letters. Determine if the center or investigator was ever cited for a noncompliance. If a citation exists, determine if the noncompliance was ever corrected.

• 6

  Ascertain the potential investigator's knowledge of Good Clinical Practices (GCP) by asking specific questions related to the clinical guidelines. This will tell you how much training will be needed during the clinical investigator's meeting.

• 7

  Confirm the facility is adequate. Visit the investigator's site where the patients will be seen. Confirm that the location is capable of providing adequate patient care, secure drug storage and other protocol requirements.

• 8

  Determine applicable staff's knowledge of GCPs. Confirm that the medical investigator has adequately trained staff to assist with the clinical trial requirements such as retention of documents, error corrections and Case Report Form maintenance. If all is acceptable and the investigator is willing to take on the clinical trial, send the protocol, investigator's brochure and other pertinent materials and start your clinical trial.