A successful business collaboration is rooted in respect, transparency, and a big picture perspective. When these characteristics accompany the creation of a partnership, they ensure the sustainability of the relationship. This philosophy is integral to investigator selection activities.
As a new CRA, I was ruffled when a site I evaluated, and recommended, declined a study. I felt that my arduous preparation for evaluation had been a wasted effort. My inexperience prevented full understanding of the holistic perspective of study start up that emphasized both current and prospective site identification. My emotional tunnel vision only saw what was before me –hard work and courtesy with no result. Thankfully, as I gained experience, I developed a strong awareness of potential opportunity and the long game require for fruition. I saw possibility in every encounter, and modified my behavior as such.
Site selection is not an exact science
When a study is not the right fit for a strong investigational site, the proverbial door does not close. When a site declines a study (for the right reasons), it is a sound business decision with reciprocal benefits. The sponsor does not waste money and resources activating an inappropriate site, and the site does not fail a study that they were not able to conduct.
Investigational site evaluation is not an exact science. An overplayed site presentation and Clinical Research Associate (CRA) inexperience can contribute to faulty site selection. That is why a truly discerning pre-study evaluation visit involves equal consideration by all parties. It is serendipitous if the site and CRA have aligned selection and participation goals, but it’s not an overall loss when a site the CRA recommends decides not to participate.
The site that declines a study will eventually accept another study that fits their capabilities and business model. Their judicious consideration will ensure their overall success, with impactful results for the sponsor (enrollment goals/deadlines met), investigational site staff (therapeutic expertise/reputation), and study patients (safety and credible data). The key to this desired result is the bigger picture of investigational site management by the CRA/CRO.
All is not lost when a site declines
I once evaluated a site for a complicated cardiology study. The study coordinator was efficient, cordial and generous with her time. She set aside four hours of her morning to complete all assessment activities and ensure I obtained all of the required site information. The regulatory and administrative support staff were professional and available to answer all supplemental questions. The facility, though small, was located on a large hospital campus within walking distance of the necessary imaging and inpatient facilities. Everything was going smoothly. Until the protocol discussion with the Principal Investigator.
The study had sophisticated diagnostic imaging requirements, which the Investigator had been informed would be available in the hospital before study start. Unfortunately, on the morning of the pre-study visit, the hospital administrator regretfully informed the investigator that the date for the equipment and software installation had been pushed back indefinitely due to institutional budget cuts. There were no alternate facilities within a reasonable distance from the site to fulfill the study testing requirements. The PI was extremely apologetic for my having traveled and prepared for the site assessment as they, regrettably, could not conduct the study.
Though disappointed, I smiled inwardly, for the day had surely not been a loss. This honest investigator and experienced cardiology site had been most gracious and accommodating throughout the entire site evaluation process. I had confirmed staff and facility appropriateness, enthusiasm and professionalism. A strong site alliance had been born from our mutual efforts, and would be fostered carefully by all parties involved.
I thanked the investigator for his transparency and informed him that several potential trials were in the pipeline that could be a strong fit for this organization. I asked if I could check in with him periodically to ensure their consideration for future trials. As predicted, he was grateful and interested in continuing the dialogue.
Develop a long-term relationship with the site
Our honest professionalism was the impetus for a strong partnership, and a holistic perspective would foster the site relationship for many successful trials to come. Subsequent evaluation visits would be far less costly and more efficient, as site capability and interest had been confirmed on this important day — a successful outcome brought about by holistic thinking.