When asking my Magic 8 Ball on the likelihood of recruiting and retaining experienced principal investigators (PIs), the responses was, “the outlook is not good.” We all know the reasons why:
- Decreased NIH grant funding available to support academic careers (1)
- Increased regulatory requirements regarding ICH, HIPAA and Meaningful Use (2)
- Study budgets have remained static, despite study complexity and requirements increasing exponentially, including an increase in electronic data capture systems each requiring lengthy training and unique logins (2)
- Lack of supporting resources (3)
- Lack of dedicated time (4)
- Lack of financial incentives and/or recognition (4)
- Lack of orientation or training for the responsibilities for clinical research, despite having the most responsibility for complete oversight of the clinical trial activities per the 1572 (4)
This is an issue that needs to be tackled by the healthcare and innovation industries, medical education, sponsors, clinical research organizations and sites in order to change the outlook to “good.” In the meantime, here is a list of what sites can do to improve the PI role:
- Offer paid training. Do not assume that just because your physicians went to medical school, they are well versed in the responsibilities and roles of being a good principal investigator. Programs are offered by the Association of Clinical Research Professionals, NIH, FDA, academic centers and private organizations. Ensure you have an orientation program to your site which translates how the site supports the PI in maintaining regulatory compliance. For example, include in your orientation that PIs and sub-investigators need to add the phrase, “adverse events and concomitant medications were reviewed with the patient.” New investigators might assume that, while their documentation demonstrates these were reviewed, the additional comment is not necessary (even though it is necessary for patients enrolled in clinical trials).
- Provide adequate support staff to delegate non-PI required duties. Examples are coordinators to screen and enroll patients, regulatory affairs coordinators, Medicare coverage analysts, lab technicians, etc.
- Provide dedicated and protected time for clinical research patients. Clinical research takes extra time for patient visits, documentation, monitoring visits, site initiation visits and safety calls. PIs cannot be expected to see the same volume of patients per day when a percentage of the patients are in clinical trials. Unfortunately, many institutions pay physician PIs on a relative value unit (RVU) model so higher volumes of patient visits translate to higher pay. This model is a disincentive to physician participation in clinical trials, as it negatively impacts their compensation. I recommend increasing the RVU for clinical trial patients, creating a bonus structure for clinical trial activity (e.g., patients referred or enrolled into clinical trials), or sharing clinical trial revenue. Creating a clinical research participation requirement without removing the barriers will be unsuccessful and will result in losing quality physicians.
- Help your PIs with clinical trial oversight. Create a routine meeting that discusses each trial (including amendments, potential issues, and enrollment), each patient on trial, and potential patients to enroll. Document attendees, the agenda, and all training that takes place. These weekly or bi-weekly meetings can be done efficiently and satisfy regulatory oversight requirements.
- Celebrate successes and acknowledge outstanding work. This can be done in organizational newsletters, social media, personal acknowledgments from senior organizational leaders, and marketing materials for your site.
- Ensure adequate clinical trial budgets to cover the expense of the complexity of the trials, the lengthy and redundant electronic data capture trainings, the frequent safety calls, time to ensure clinical trial oversite (team meetings), and ongoing training for PIs. Sponsors expect experienced, quality investigators to run their clinical trials. However, like in all businesses, there must be fair compensation for their time and efforts. The sites cannot take on that burden alone.
PIs are like most people in clinical research – they want to do a great job to serve their patients and advance science. Our job as site administrators is to ensure they have the training, time, and resources to help them be successful. Maybe then, our Magic 8 Ball will respond, “Signs point to yes” when asked about recruiting and retaining PIs.
Note: This article originally appeared in the September, 2017 edition of SCRS Insite: The Global Journal for Clinical Research Sites.
1 Lauer M. How many researchers? Extramural Nexus. May 31, 2016. Accessed July 2017 from: https://nexus.od.nih.gov/all/2016/05/31/how-many-researchers
2 Morgan C. Is clinical trial design complexity behind the high turnover rate for principal investigators? MedCityNews. April 24, 2017. Accessed July 2017 from: http://medcitynews. com/2017/04/high-turnover-rate-for-principal-investigators
3 Jacobs SR, Weiner BJ, et al. Organizational and physician factors associated with patient enrollment in cancer clinical trials. Clinical Trials. 2014;11(5)565-575.
4 Rahman S, Azim MA, et al. Physician participation in clinical research and trials: Issues and approaches. Advances in Medical Education and Practice. 2011;7(2):85-93.
About the Author
Molly has over 18 years of health care experience with specialization in oncology, research and health care administration. Now Molly shares her experience and expertise with sites as a Medix Clinical Research Consultant.