The Pathway to Principal Investigator
By Nikolas J.S. London, MD
My journey from sub-investigator during fellowship to my current position as a principal investigator (PI) started when I expressed interest in clinical trial work upon joining my current practice. Over time, I found I was quite passionate about the work and took on more and more responsibility, eventually overseeing 10 to 15 studies. If you’re a budding sub-investigator curious about whether becoming a PI is right for you, read on.
Understanding a PI’s Responsibilities
Before studies even begin, PIs are responsible for identifying research opportunities. They often receive invitations to collaborate from sponsors and/or Clinical Research Organizations (such as CTRG), or sometimes directly from sponsors themselves. PIs handle feasibility questionnaires, ensure eligibility for clinical trials, and oversee budget and contract negotiations. When they decide that a study may be a good fit for their practice, the PI oversees the startup phase and initiation visits. As the trial progresses, the PI is responsible for recruiting candidates and ensuring that the study's conduct aligns with the stipulated protocols.
To those focused on a PI’s research-specific duties, remember, that the role of a PI is multifaceted. The PI is the point person for the study, ensuring that every phase is conducted correctly. Attention to detail is crucial, as is ensuring that there are no deviations from the protocol. A good PI ensures that everyone involved—from technicians to financial experts to practice administrators—is on the same page. Contrast this with the responsibilities of sub-investigators, who focus only on specific clinical aspects of a trial.
Tips for Aspiring PIs
Anticipate Growing Pains: Even the most prepared PI will encounter unanticipated hiccups. If you overestimate the financial investments needed for scaling up clinical trial work, overinvest in quality staff members, and accept the fact that you might encounter rough waters irrespective of your preparation, then you’ll have the right headspace and infrastructure to navigate the unexpected.
Match Your Site to the Right Study: If a study isn’t a good fit for your practice, don’t force it. Consider your interest in the trial’s central questions, whether your clinic’s patient population suits the enrollment criteria, and if your practice has the capacity for this particular study. While financial considerations play a role, they are typically secondary to ensuring that the trial aligns with the clinic's capabilities and patient needs.
Work with an MSL: A Medical Science Liaison (MSL) is an invaluable resource for finding research opportunities. MSLs serve as a direct link to a sponsor, assist with scientific questions, and offer guidance during research. They can also help practices get invited to participate in clinical trials. MSLs provide tactical support throughout the process, especially when navigating challenges or seeking clarifications during a trial. If there is a specific sponsor you would like to work with, reach out to an MSL at that sponsor and build a relationship.
Principal Investigator: Not a Role for the Faint-Hearted
For those looking to embark on the journey to becoming a PI, it’s important to understand the intricacies of each clinical trial, build a reliable team, maximize your professional network, and build in infrastructure more substantial than what’s initially needed. Start with a small study or focus on a few clinical trials before gradually expanding as you gain experience and resources. After years of hard work and thoughtful, strategic investment, you may find yourself serving as PI for a handful of studies—that is, as long as you keep building and improving the quality of your work.
About the Author
Dr. London is the President and Director of Research at Retina Consultants San Diego, and the Chief of Ophthalmology at Scripps Memorial Hospital in La Jolla, California.