Recruit 350 randomised patients across 35 sites in 50 weeks
CCA identified sites for the study and secured their participation through ensuring a high level of site support to help identify and contact patients from our GPs’ databases and then filtered this shortlist through rigorous note trawls. This required huge levels of resource on-site that would not have been available at a non-managed site.
Site Management Case Study
The customer was a large biotechnology company whose investors had a close eye on the success of the study. Recruitment was anticipated to be challenging, due to both the sensitive nature of the condition and the difficulty of recruiting from a new and unknown patient pool. CCA’s target was 350 randomised patients across 35 sites in 50 weeks.
The Challenge
The condition in question was new relatively new to the UK and Irish Health services in terms of clinical research and therefore previously been unrepresented in clinical trials and had recently come to the forefront due to the change in the Irish and UK government reporting in relation to Hospital virus’s and improved microbiology screening . Furthermore the exclusion criteria were experimental based on assumptions regarding the target patient population. Finding interested research sites would also be a difficult task as there was no guarantee of finding suitable patients. This was a real recruitment challenge.
The CCA approach
CCA identified sites for the study and secured their participation through ensuring a high level of site support to help identify and contact patients from our GPs’ databases and then filtered this shortlist through rigorous note trawls. This required huge levels of resource on-site that would not have been available at a non-managed site. Critically via Patient Approach List Management, CCA recorded the reasons for non-participation in screening. In this way CCA was able to rapidly identify a key barrier to recruitment and recommend an appropriate protocol amendment to the Customer.
The Outcome
The professional management and flexibility of resource at CCA Managed Sites enabled the Customer to achieve target recruitment results in a relatively risky, pioneering trial in an unknown patient pool. Non-managed sites would have lacked the resource and organization to respond so rapidly to new information and adapt recruitment strategy accordingly throughout to save the Customer time and money before screen failure costs built up. CCA’s site management allowed the Customer to set investor expectations with confidence in the ultimate delivery.
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