Clinical Researcher—August 2022 (Volume 36, Issue 4)

ON THE JOB

Elizabeth Weeks-Rowe, LVN, CCRA

 

Investigational site models are as diverse as the infrastructure and personnel that embody their missions. Yet, they all share a compelling origin story; the seedling idea, steps, and struggles that wrought their inception to this field. The story of how an inspired individual or an entire investigational team worked to create a research company/site and overcome the challenges involved (finances, staffing, strategic relationships, logistics) provides insight into their sustainability, and sometimes, success. The most memorable stories do not necessarily involve extraordinary physician/entrepreneurs, but regular individuals with an extraordinary passion for clinical research.

In the following real-world stories of a few such individuals, the workplace details are accurate, but their names have been changed to protect their privacy.

From Study Coordinator to Research Company Owner

Several years ago, I was tasked to evaluate an investigational site for a diabetes study. The feasibility questionnaire identified the site’s principal investigator (PI) as an internal medicine physician, and as a PI with a research department in their medical practice was a common site model, I assumed the study coordinators worked for the PI.

The site evaluation visit was quickly scheduled by a responsive coordinator and I was looking forward to the assessment process. The day of the visit arrived, and as the receptionist escorted me to the coordinator’s work area, I noted the research area shared space with the PI’s main clinic area. However, in speaking with the coordinator I discovered how wrong I had been with my initial presumption; the research site may have been in the PI’s practice, but the coordinators absolutely did not work for the PI. Rather, the primary coordinator owned the research company with which investigators contracted to conduct their clinical trials. That provided just a hint as to how inspirational the company’s origin story was when I heard all the details.

Linda, the primary study coordinator/owner, had worked at a dedicated research site for many years. During her tenure she had become close friends with another coordinator named Mary. They were both medical assistants by training, extensively experienced with the clinical responsibilities of the study coordinator role. They also developed research administrative skills with their involvement in contracts/budgets while working at the research site.

Eventually, the site was purchased by a large healthcare organization and the mission changed with the ownership. There was much more emphasis placed on financial incentives/study acquisition than patient safety/credible data, and the change made Linda vastly uncomfortable. She had entered the field of clinical research to participate in drug development, which included upholding those critical tenets. She could no longer work for an institutional model that did not align with her convictions, and thus the idea for her company began.

Linda had met several coordinators/site owners at investigator meetings over the years, but did not have the first idea about how to go about forming a research company. She spent a year researching and preparing for the change. She spoke with banks about small business loans and research financing. She spoke with attorneys about clinical trial agreements and budgets. She had always performed well on her studies and maintained strong relationships with her monitors, so the critical relationships required for study leads were established.

She then began to reconnect with previous investigators with whom she had worked for the possibility of partnerships. She knew she could not afford to lease the appropriate working space, so she decided the best option would be to lease space in an investigator’s already-established practice. Through networking she was ultimately connected to an experienced sub-investigator with extra clinic space, and who was looking to move into the PI role. He provided infrastructure and she provided knowledge, personnel, and trial contracts.

When all the required financial, clinical, and logistical components were in place—and especially once the partners had secured their first potential study—Linda gave notice at the site she had come to feel out of place at and never looked back.

It had been a daunting process of balancing the books to ensure their seed money lasted long enough for them to begin qualifying for studies that would keep the bills paid after the early funding ran out. Though the struggle was sometimes nearly overwhelming, she persevered until they were profitable, and they were able to hire a second coordinator, her friend Mary. Linda never dreamed that her commitment to research integrity would lead her to site ownership and the discretion to make the kinds of decisions that would truly serve the best interests of her patients.

Finance Guy Becomes Research Director

Approximately two years ago I was involved with site selection for a cardiology study and was asked to conduct an evaluation visit in Southern Florida. The site was added at the last minute due to its extreme persistence and the sponsor’s need for investigators with access to the unique population of patients available in that area. The potential cardiologist PI was new to clinical research, but had a large patient database and was working with a dedicated research site.

The research site director had doggedly pursued the study lead until the sponsor yielded (it was typically hesitant about any new investigator) and allowed the evaluation visit. An inexperienced investigator required a more complex assessment process, so I made sure I was adequately prepared.

When I arrived at the site, the research director met me in the lobby and introduced himself as David. The research site was adjacent to a clinic that David explained was the medical practice of his business partner, Michael, who was a primary care physician and experienced PI.

Michael and David co-owned the research site, and had been acquainted with one another long before striking up the business partnership—since high school, in fact. David was refreshingly transparent as he explained the story of their collaboration, noting how Michael was a primary care physician and an experienced investigator, having served as a sub-investigator on other cardiology studies (which lent credibility to their idea that Michael would support the new cardiologist investigator they had enlisted to serve as a potential PI on the cardiology study for which they were being evaluated). In earlier days, they had often discussed starting a business, but as they grew older so did the gap in their career interests, leaving the idea of a shared business adrift for the time being.

While David pursued a business degree and worked in finance, Michael attended medical school and started a thriving medical practice. They corresponded by e-mail, but had not spoken in several years until Michael contacted David about starting a clinical research site—he had the clinical experience, but needed David’s business and legal acumen for the research site administration. David had never let go of the idea of starting his own business, but had not found a business model that piqued his interest until Michael contacted him, so their childhood dream finally moved forward to fruition.

They secured financing from personal and family investments. They leased additional space next to Michael’s practice and organized their site. David learned all aspects of clinical research administration while hiring two experienced study coordinators and a research assistant. It took almost six months to obtain and start their first study, and my evaluation visit was for what would only be their second study.

David was extremely enthusiastic and determined to succeed, which was evident in his presentation to me. Before I opened my laptop, he provided me a notebook filled with staff training certificates and site standard operating procedures. They had given their chosen PI for the new study additional regulatory guidances to review in preparation for the investigator role. David explained that Michael was going to be a sub-investigator and work with the PI on the first several screening visits to assure his familiarity and compliance.

Their study coordinators were adequately experienced, and their site was organized and well equipped. Their PI was professional and came prepared to discuss the protocol design as well as his access to the study population. They had completed due diligence in preparing for the evaluation visit and the various support methods to accommodate their new investigator. They had worked tirelessly to open their site and the diligence continued in the preparatory efforts to obtain studies.

Conclusion

These stories serve as just two examples of how research sites might spring to life and how, sometimes, it takes promoting yourself into a new position to get the job done. They also go to show how successful research partnerships start where science and business intersect for ethical study conduct.

Elizabeth Weeks-Rowe, LVN, CCRA, (elizabethwrowe@gmail.com) is a former clinical research coordinator who now works in site selection and education in the contract research organization industry. She last wrote for Clinical Researcher in December 2021 (“A Chance Encounter: When CRAs and Study Patients Meet”).