In the world of clinical research, every new study brings with it the challenge for sponsors and CROs to navigate the complex process of site selection. This involves choosing from tens of thousands of research sites globally, a task that’s as daunting as it is critical.
The feasibility process, alongside the bidding and bid defense stages that CROs undergo to secure a study, are fraught with well-documented challenges and frustrations. A less discussed aspect, however, is the potential oversight in recognizing the aggregate capacity of clinical sites within a specific geographic area. While individually, sites may seem to lack access to sufficient numbers of the target study population, collectively, they often represent a significant pool of prospective participants.
This competitive landscape, where CROs vie for sponsor contracts and sites for CRO projects, mirrors the broader business world’s competitive nature. Despite this, there’s a notable culture of knowledge-sharing among sites, with forums and groups like the Site Solutions Summit (https://sitesolutionssummit.com), Save the Sites (https://www.linkedin.com/groups/2450033), and SOS Save Our Sites (https://www.linkedin.com/company/sos-save-our-sites) providing platforms for exchanging insights on contracts, budgets, recruitment strategies, and more. Yet, this spirit of cooperation tends to wane post-award, particularly among local competitors.
Imagine a scenario where multiple sites within a city compete for a single study slot. The combined potential enrollment capacity of these sites significantly exceeds what any one site can offer alone. However, the current model, which limits selection to just one or a few sites, fails to capitalize on this collective potential, resulting in a substantial loss of enrollment opportunities.
This is where a paradigm shift towards more collaborative models, inspired by the general and subcontractor framework common in other industries, could make a substantial impact. Such an approach would allow the primary site to lead the study while enabling others to contribute, possibly through patient identification, consenting, or even conducting certain study visits under a decentralized clinical trial (DCT) model. This not only maximizes enrollment potential but also fosters a more inclusive and efficient research environment.
Achieving this requires building a foundation of trust among sites, ensuring that collaboration does not lead to competitive disadvantages in future projects. It also calls for sponsors and CROs to facilitate and endorse these collaborative efforts, providing pathways for subcontracting that recognize and compensate the contributions of all involved sites.
While shifting from the established model to a more collaborative approach will take time, the potential benefits for recruitment, site success, and the overall appeal of clinical research as a field are immense. I encourage sponsors and CROs interested in exploring this hybrid model to connect with us. Together, we can pioneer a more inclusive, efficient, and successful framework for clinical research.
