Winter 2023 - Vol. 18, No. 4

SPOTLIGHT ON CLINICAL RESEARCH
 
Success Stories, What’s Next, and How You Can Help
 
kabagambe madara
Kabagambe                     Madara     
                                        
 Edmond K. Kabagambe, DVM, PhD, MS, MBA, FAHA, FACE
Vice President, Research Administration
Heather Madara
Research Regulatory & Outreach Manager
Penn Medicine Lancaster General Health Research Institute

 
In June 2022, the Penn Medicine Lancaster General Health Research Institute welcomed Dr. Edmond Kabagambe to the health system as the inaugural vice president of Research Administration. In the time since his arrival, research across LG Health has become more cohesive and streamlined with a strong focus on collaboration both internally and with other Penn Medicine entities. In the following article, Dr. Kabagambe shares examples of what we have been able to achieve and what exciting opportunities await in the future.

Over the past year, many physicians accepted the call to serve as principal investigators (PIs) or sub-investigators (Sub-Is) for clinical research. This role comes with many responsibilities, including completing or renewing CITI (Collaborative Institutional Training Initiative) certifications, meeting with the study team, reviewing and signing off on all study updates, and more. Among the 347 unique CITI certifications in Fiscal Year 2023 (FY23), 53 were from physicians and 26 were from advanced practice providers (APPs).

We recognize that a patient is more likely to consent to participate in a study if they hear about it from a provider rather than from any other member of the study team. Enrollment has seen a marked increase as a result of the great engagement of CITI-certified physicians, APPs, nurses, pharmacists, and other researchers. In addition to being instrumental in enrollment efforts, CITI certifications also allow us to maintain a high standard of regulatory compliance.

This excellence in regulatory compliance was highlighted prominently in the Association for the Accreditation of Human Research Protection Programs (AAHRPP) reaccreditation of the LG Health Human Research Protection Program (HRPP), a months-long process that required inter- and intra-departmental efforts, policy revisions, and interviews coordinated by Jonathan Derr, administrative director of the Research Institute. Our HRPP has been AAHRPP-accredited since 2015, signifying that the HRPP meets the most rigorous standards for maintaining the safety of research participants.

Recent achievements from providers, pharmacists, nurses, research coordinators and assistants, and the research administration team are shown in Table 1. For example, nearly 1,000 unique patients were consented and enrolled in clinical research studies. Compared to FY22, the number of new patients in non-cancer clinical studies increased by 38% in FY23, and enrollment of minorities increased from 5.8% to 7.2% in the same period.

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While these advancements are certainly worth celebrating, we are also excited about the future of research. There are still many departments and patients that could benefit from clinical research. One of our goals for FY24 is to continue to expand clinical research across service lines and departments, while simultaneously increasing patient diversity by race, ethnicity, sex, and other demographics. We continue to work closely with the Diversity, Equity & Inclusion department to align our goals and ensure respect and safety for research participants.

We are starting up several new studies that will enroll patients from rural and suburban practices to afford residents in those areas the opportunity to benefit from clinical research. These include studies on postpartum depression, diabetes, health misinformation, and more.

One simple way to facilitate research at LG Health is to encourage patients to enroll in MyLGHealth and opt in to learn more about research studies for which they might qualify. This allows the research team to reach patients wherever they are.

Research is truly a team effort; we could not do what we do without the support, resources, and efforts of investigators, statisticians, pharmacists, the Information Services team members, and countless others. We look forward to welcoming more researchers to our efforts and cannot wait to see what opportunities the future holds for research at LG Health and beyond.

To learn more about the cutting-edge research taking place at LG Health, visit lancastergeneralhealth.org/health-care-professionals/research-institute.

If you are interested in becoming a research investigator, contact the Research Institute via email at LGHResearch@pennmedicine.upenn.edu.