In addition to our existing database of > 2,500 proven, high-enrolling investigators/sites, we have also built a database of more than two thousand treating physicians who are proactive in out-patient clinics, private and regional medical centers that are not accredited to conduct clinical trials. We have reached out to them and executed confidentiality agreements that allow them to review studies we are running in their specific therapeutic areas, and to refer patients to our clinical trial sites. Therefore, when we conduct formal feasibility and/or begin to enroll patients into a given clinical trial, if we suspect that enrollment could be complicated, we are able to check our database of potential referral sites. We then inform them of the study, its inclusion and exclusion criteria, and encourage them to refer their patients to trial site locations that are most proximal to them. This is practiced very effectively in study situations wherein, for example, a unique capability is required of the participating site(s), such as a complex surgery. We then create a ‘hub and spoke’ strategy of referral sites (spokes) to send patients to the uniquely capable ‘hub’ site(s).
See below a real-life example of improvement in enrollment of in an orphan disease trial with the addition of Cromos Pharma’s referral site network.
Case study: Cromos Pharma was approached to conduct a clinical trial in an orphan disease. The study was already ongoing in 11 countries and the recruitment was seriously lagging behind. We performed a feasibility study in our region and realized that even our highest-recruiting sites would have difficulties with recruitment. Upon receiving the approval from the sponsor, we engaged our referral site network in order to include patients referred by physicians who have large patient populations, but who have chosen not to be accredited to conduct clinical research. We subsequently opened 18 sites in 4 countries and engaged with 72 referral sites. In less than 9 months of study conduct we outperformed the recruitment in all other countries. In analyzing the recruitment data we found that 40% of recruited patients came from our referral network.