5 Straightforward Ways To Support New PIs

By Lauren Ballina Chang, Vice President of Strategic Growth, Clinical Research Fastrack

Data collection oversight, protocol execution, IP dispensation, adverse and serious adverse event evaluations, regulatory compliance, case report form (CRF) sign-off, and more — all are done by principal investigators (PIs). What would we do without them? We wouldn’t be able to run our protocols that have cost us millions and have spent years in development. We wouldn’t be able to touch the lives of participants. We wouldn’t be able to move medicine forward and create better clinical outcomes.

In the United States, a physician’s academic trajectory is long and demanding. It typically includes approximately four years of undergraduate school, four years of medical school, three to seven years of residency, and for the hyper-specialized, one to three years of fellowship. At each step, a physician becomes more specialized and able to treat patients accordingly. “Research” is usually part of this development, but clinical research is not. Physicians are exposed to basic scientific research, case reports, and perhaps data mining in the electronic medical record (EMR) to run some stats — all to write a manuscript on retrospective data but not conduct a true interventional study. There is no clinical research residency to become a PI. There is no clinical research fellowship to become a PI.

Yet, when sponsors are selecting new PIs, they typically want physicians with clinical research experience. But where do they get this experience? As an industry, the onus falls on us to provide the proper training, support, and mentorship for physicians who are interested in and enthusiastic about clinical research. What’s more, we want to avoid the one-and-done phenomenon, where an eager new PI starts up a research practice but quits after the first trial due to a lack of support, proper funding, and/or understanding of what is required. Thankfully, we are uniquely positioned right now, as seasoned PIs retire, to develop the next generation. Here are five best practices for building up the best PIs in the industry.

1. Build Physician Awareness And Excitement

During residency, physicians must work on a (often dreaded) research project. They dig into data sets and grind through the process of collecting, cleaning, and analyzing data that ultimately leads to a written report. This research project is what they (incorrectly) envision when clinical research is proposed later in their career. Rather than a much-maligned slog, clinical research can be a very exciting process where a physician holds an active role in advancing science and medicine.

Our industry needs to do a better job marketing this opportunity to physicians. This can be achieved through course work during medical school as well as talks delivered by clinical research industry leaders during residency and fellowship. To reach the attending physician audience, clinical research industry leaders should be given the opportunity to present at conferences that physicians attend. Some major highlights to share with physicians: becoming a leader in their chosen specialty, offering more options for their current patients, making their practice more attractive for future patients, and even increasing and/or diversifying their income and their practice. Each potential PI will have different motivations, so it is important to convey this wide variety of positive opportunities. It must be stressed that clinical research is not the research of their residency.

2. Offer Training Early And Often

Remember, doctors didn’t become licensed physicians overnight. It took years of training, studying, and test-taking to get there. The oft-cited obstacle for clinical research training is that physicians are much busier once they embark on their clinical practice. To accommodate that time crunch, one option for training PIs is a dedicated short period of time for immersive, hands-on GCP certification. Live sessions (in person or virtual) allow physicians to ask questions, express what obstacles they foresee, and be challenged to practice the skills they will need when it’s their name on the 1572. And let’s train new PIs early in their practice.

Now, a succinct yet immersive training is simply not enough to become a fully independent PI. This training must extend throughout the PI’s first clinical study, continuously repeat concepts initially trained on, and provide a safe space for PIs to ask questions throughout the trial. A well-designed curriculum, delivered in a brief, yet hands-on, immersive format is a great solution to prepare new PIs. The key is to require immersive bursts of content and revisit these concepts frequently, particularly as these PIs encounter more and more real-world situations.

3. Provide Mentorship

In residency, budding doctors train under board-certified physicians in the specialty into which they are matched. This is how they learn to become treating physicians, with the ability to triage problems and prescribe the appropriate regimen or intervention. Since this model is familiar to them, why don’t we tap into that when bringing up new PIs? Pairing new PIs with seasoned PIs can provide a resource and a confidant when unfamiliar situations arise. It is well known that sites with proven track records are tapped again and again for trials. The PIs at these organizations may be good mentor candidates. Another option is to contract retiring PIs to help bring up this next generation.

4. Lend Start-Up Support

One major barrier that I have encountered repeatedly is the high cost of entry for new PIs. It takes upfront investment, with no promise of a well-compensated study, for a PI to get started. We are talking about tens if not hundreds of thousands of dollars. Yes, this investment shows dedication but not necessarily ability. Without the proper infrastructure and support, a new PI will never be chosen for a trial.

This type of support starts and ends with the sponsors. Let’s show some trust in our up-and-coming PIs by providing them with start-up funding or with access to a CTMS, eSource software, and eRegulatory system. When new PIs consider all their options, it can be overwhelming and costly to make a choice. Right now, these decisions are often made after the fact, once a PI already starts a trial or signs on to something that doesn’t actually fit the site’s needs. Let’s partner with our vendors to provide a path for them to get started. Start-up support also can include providing a seasoned coordinator who can guide them through their first trial. This process shouldn’t rely only on those able to pay to play.

5. Give Feedback

Too often in this industry, our sites don’t know when they are failing until it is too late. Let’s address this early in the process by giving feedback early and often to new investigators. (And if they aren’t awarded a study, let them know why so next time they can achieve the award.) This feedback can include needing more training, asking for more information about their site demographics, inquiring about their plan for bringing on dedicated research staff, or even just clarifying how they plan to recruit participants. New PIs likely have all the information sponsors need during the feasibility process, they just don’t yet know what they need to provide.

Once a study is awarded, sponsors can’t let new sites flounder. Check in with the PIs to understand what support they need. Make sure they know the sponsor is on their side, and they are more likely to deliver outstanding results. Lastly, let’s remind sites often how important their work is, what they are contributing to, and how they are the boots on the ground moving medicine forward. Even though clinical research is a business, let’s lead with hope and inspiration first, and all kinds of success will follow.

Bonus Tips: Get Ahead By Attracting New Talent

• Industry leaders need to give talks at medical schools and residencies about incorporating clinical research into their future practice.
• Offer Continuing Medical Education credits for training.
• Attend conferences to generate new interest by potential PIs, particularly in up-and-coming therapeutic areas where we can predict we will need more sites.
• Develop a pathway that guides and measures PI preparedness as they seek their first trial.
• Don’t make feasibility a guessing game. Let PIs know exactly what they need to do to be awarded a trial.

While there are many ways to attract and develop more talent into the PI pool, these strategies are ones I have found to be successful. We cannot continue to do the same things and expect a different result. We cannot only rely on sites with experience and PIs who have done this before. Let’s prepare ourselves to properly prepare the next generation of PIs.

About The Author:

Lauren Ballina Chang is an educator and innovator in the clinical research training space.  She first gained experience at the University of North Carolina at Chapel Hill where she coordinated and designed longitudinal observational and interventional trials. She subsequently coordinated trials at Mayo Clinic Arizona, assisting in the development of a new area of research under the existing oncology umbrella. Lauren is versed in protocol writing, grant writing, data analysis, and has published findings in top journals. In her current role as Vice President of Strategic Growth at Clinical Research Fastrack, Lauren is challenging the industry to think differently about ways to grow and diversify the clinical research profession. Lauren has demonstrated that through hands-on training, mentorship, and connecting people to their purpose, we can solve the current workforce shortage and increase diversity and representation throughout the field.