How to Succeed as a "True" PI

I began writing these articles for The Monitor in an attempt to share with other principal investigators (PIs) the challenges and rewards of conducting pharmaceutical research in patients under my geriatric practice “wing.”

Knowing that current state-of-the-art pharmaceuticals are always needing safer and more effective profiles, I long ago began to involve myself in combining my geriatric medical practice with a small amount of Phase III and IV pharmaceutical testing. However, not having a mentor or role model while in medical school, nor a residency or fellowship, nor seeing any books on being a qualified PI, I set out to teach myself and eventually earned the Certified Physician Investigator (CPI®) designation. Over the past 25 years, I have learned great lessons in being a “true” PI, as opposed to the other type you may have heard about, for whom the initials mean “practically invisible.”

I also believe that GCP must stand for Great Clinical Practice, not Good Clinical Practice. I hope these many lessons learned over the past two-and-a-half decades can help mold future and current PIs into the highest quality of investigators possible. Let us put an end to the Practically Invisible PI!

Joel S. Ross, MD, FACP, AGSF, CMD, CPI, LLC

  1. PI: Principal Investigator or Practically Invisible?
  2. Taking SAE Reports Seriously
  3. First Contact
    Handling Potential Subjects on the Phone and in the Office
  4. Retention of Study Subjects
    How the Practically Invisible PI Loses Patients and the Real PI Helps Retain Them
  5. Medical History and Review of Medical Records
  6. To Enroll or Not to Enroll?
  7. The Role of the Subinvestigator
  8. Investigating Investigator Meetings
  9. You Can’t Choose Whom You Relate To
  10. Why (and Should You) Become a PI?
  11. Vendors
    The More is Not the Merrier
  12. Ask Not What Your Research Coordinators Can Do for You . . .
    . . . but what you can do for your research coordinators!
  13. Challenges and Pitfalls for Clinical Research in the 21st Century
  14. Working with Your Medical Monitors
  15. When a Sponsor Says NO, Can a PI Say YES?
  16. Critical Lab Value
    Critical to Whom?
  17. The Business of Clinical Research as an Owner/CEO/PI
    Know Before You Go!
  18. Finding Studies and Recruiting Patients
    Is There Synergy?
  19. Meeting Your Research Subject’s/Study Partner’s Expectations
  20. When Few Adverse Events are Bad News

  21. Violation or Deviation: What's the Difference?

About the Author
Joel S. Ross, MD, FACP, AGSF, CMD, CPI, LLC, is founder, chairman, and president of the Memory Enhancement Centers of America, Inc., in Eatontown, N.J., a Phase I, II, and III Alzheimer’s disease evaluation and treatment center. He is also a clinical associate professor of medicine at Mount Sinai Medical Center in New York City. Dr. Ross also serves on the Board of Trustees for the Academy of Physicians in Clinical Research, an affiliate of ACRP.

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