/ /

  • linkedin
  • Increase Font
  • Sharebar

    Do you have what it takes to be a principal investigator?

    Editor’s Note: Welcome to “Eye Catching: Let's Chat,” a blog series featuring contributions from members of the ophthalmic community. These blogs are an opportunity for ophthalmic bloggers to engage with readers with about a topic that is top of mind, whether it is practice management, experiences with patients, the industry, medicine in general, or healthcare reform. The series continues with this blog by Mark Packer, MD, FACS, CPI. The views expressed in these blogs are those of their respective contributors and do not represent the views of Ophthalmology Times or UBM Medica.

    Ophthalmologists often approach me about getting involved in clinical research, mostly because they know that I’ve been a principal investigator, medical monitor, or clinical consultant in over 60 trials related to FDA clearances and approvals.  Here’s what I tell them.

    Being a principal investigator demands a very different set of values from being a practicing ophthalmologist.  While the World Medical Association’s Declaration of Helsinki and the International Conference on Harmonisation’s Good Clinical Practice (GCP) documents underlie the ethical conduct of clinical research, the successful application of these concepts requires that surgeons adopt a fresh perspective on their daily work.

    More from Mark: Sitting on the dock of the bay

    The purpose of clinical research for regulatory review is to collect data that will allow a determination regarding the safety and effectiveness of novel drugs and devices.  While there are excellent resources available from many sources—including guidance documents from the FDA, which describe the principles and processes involved in conducting research—intellectual understanding does not generally lead in and of itself to sustained success.  Practical experience is often necessary to build the transition from theory to practice.  My observations here should not be taken as a textbook chapter on clinical research; rather, they are my personal perspective based on 20 years of experience in the field.  

    1. Responsibility

    New Call-to-action


    You must be signed in to leave a comment. Registering is fast and free!

    All comments must follow the ModernMedicine Network community rules and terms of use, and will be moderated. ModernMedicine reserves the right to use the comments we receive, in whole or in part,in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.

    • No comments available


    View Results