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.

Difficulty: Moderate

Instructions

Things You'll Need:

• Knowledge of clinical research
• Computer
• Internet Access

1. 
   Get a qualified person

   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 sugical intervention like inserting a stent, you would want to find a medical investigator who does this for a living, not a podiatrist or general practioner.

2. 
   Search the internet for candidates.

   Use various resources.
   
   Perform an internet or 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.(See resource section below for an example).

3. Test the waters.
   
   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.
   
   Once selected, request a copy of the current curriculum vitae (CV) and their medical license (as applicable). Review the documents and determine if he or she have significant experience with the condition under investigation to perform the protocol requirements.

5. 
   Check debarment and disciplnary lists.

   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 US 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 non-compliances. If a citation exist, determine if the non-compliances were ever corrected.

6. Ask questions about Good clinical Practices.
   
   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. 
   Interview the staff

   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.

Tips & Warnings

• Make sure you check the investigator for debarment and disciplinary actions as this can impact the clinical trial data including having it disqualified and thrown out.

Resources

• Investigator Location Services, Inc.
• Excluded Parties List System
• FDA Disqualification and Debarment Lists
• How to Coordinate a Successful Clinical Trial Collaboration
• How to Understand the HIPAA Privacy Rule and Clinical Research

[Limowreck]

on 6/22/2008 What an interesting topic. I never really thought about it. Thanks!