Identifying viable study sites presents a challenge in many clinical trials. Biosimilar development is especially challenging as the number of sponsors preparing to broaden access to today’s blockbuster biologics, by providing lower-cost biosimilar alternative, continues to grow. While this flood of research activity will make a significant improvement for patient access to breakthrough treatments, it has also created an increasingly competitive environment for finding suitable, experienced sites.
Compounding the issue, physicians are often less interested in supporting biosimilar studies, preferring to engage in clinical trials involving novel targets and compounds or those being conducted by larger academic institutions. Additionally, the level of education and training regarding the established development process for biosimilars is generally low. To overcome these hurdles, we have expanded its strategy to help sponsors find qualified sites and investigators willing to provide reliable clinical evidence.
Looking beyond the usual suspects
Sponsors may be caught off guard when they rely on databases which have been compiled primarily based on the historical performance of sites and investigators engaged across a broad range of study types.
Stephen Jasperse, senior director for investigator and health system relationships, explains:
“In the United Kingdom, we find that companies approach the typical list of investigators, the customary targets and are then surprised by the lack of response received. And, beyond not being interested in biosimilar studies, many of these well-known sites simply don’t have the capacity to take on an additional study.”
Compiling a reliable network
For clinical development involving any type of molecule, but especially with biosimilars, a one-size-fits-all approach is rarely effective for a global clinical trial. Sponsors must recognize regional and country differences to adapt their process and yield the best results in terms of feasibility, site identification, study setup and performance monitoring.
A country-specific difference can also be recognized as an opportunity for improved outreach. The National Institutes of Health Research (NIHR) Clinical Research Network (CRN) has recognized sponsors’ struggles with biosimilar development in the U.K. In response, a scoping exercise was initiated in 2016 to develop a list of U.K.-based clinicians willing to conduct clinical trials of biosimilar drugs, and already over 600 potential investigators have been identified.
Building a trusted partnership
With a strong research and clinical presence in the United Kingdom, we are closely aligned with the processes and practices of the NIHR Clinical Research Network (CRN). The team was thrilled to learn about this proactive initiative which will provide new and alternative resource to help advance biosimilar trials by facilitating rapid site identification.
The NIHR CRN tool was recently put into practice to support one of its sponsors. The process yielded 19 willing and capable investigators who were immediately available to support a biosimilar study, a notable difference considering that the sponsor received zero interest after directly approaching 50 U.K. sites from their standard list.
Armed with another strategy for site selection and patient recruitment, the team continues to grow its relationship with this U.K.-based network. “We are genuine advocates for NIHR CRN because we see that it works so well,” says Jasperse. “They also function as our partner to provide experts that can help us develop protocols and connect us with therapeutic area specialty leads.”
With the ability to tap into national communities of clinical practice, the NIHR CRN hopes to encourage more sponsors to bring their research to the U.K. In turn, the teams can offer this extension of their expertise to sponsors running global trials, accelerating the research process and advancing biosimilar development.
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