Patient Recruitment & Retention Services
Case study
Large global cardiovascular outcome program
The challenge
A large pharma organisation had plans to recruit a total of 28,000 patients for two global mega Cardiovascular Outcome studies. There were a number of challenges to this ambitious patient recruitment plan from the outset. Notably a patient recruitment road map and consolidated plan was not put in place initially as part of the overall study project timeline. Another major challenge was that multiple vendors were being managed by the sponsor with overlapping and competing strategies. In addition to this, various tactics were being deployed in different geographical locations which were not being coordinated correctly. There was also a lack of transparency on what had been implemented to support patient enrollment. ICON was engaged by the sponsor late in the study process to provide solutions to support the patient recruitment process for positive outcomes.
The solution
ICON developed an overall plan which included recruitment and retention planning, tactical implementation, vendor oversight processes and direct site support. ICON reviewed all of the vendor strategies and suggested a concise and consolidated vendor management plan. We also arranged oversight to allow tie in with clinical site management activities. Centralised individual site recruitment plans were developed and implemented. These included detailed tactics which enabled patient recruitment staff to proactively support sites in their recruitment activities. Lessons learnt were shared between the sites involved in the study to encourage collaboration and transparency and additional site training sessions were rolled out where required. Clinical Enrollment Assistants were deployed to a subset of sites based in the US that needed that extra support. ICON also successfully implemented a digital outreach campaign which was conducted in 8 different countries which included: Czech Republic, Denmark, Finland, U.K., Hungary, Netherlands, and South Africa.
These centralised individual site recruitment plans enabled ICON to identify recruitment barriers and to access and promote the use of available tools. ICON was also able to identify and share best recruitment practices and to carry out additional site training sessions to answer site questions and support materials included a study App which was customised for desktop use. Patient recruitment specialists held multiple training sessions with the ICON clinical team and CRAs ensuring they were well versed on the tools, tactics and potential solutions which were available to them. CRAs were provided with phone scripts for discussing recruitment strategies to enable them to become recruitment advocates. In addition, on-site enrollment assistants were deployed in a subset of US sites supporting all aspects of recruitment but particularly on-site clinical chart reviews.
ICON’s value add
ICON develops highly targeted recruitment and retention strategies at the outset that increase engagement throughout the patient journey.
Our patient insight services are designed to leverage the patient perspective for feasibility, recruitment and retention. This insight, based on information from patient surveys, forums and focus groups, also supports our patient recruitment and retention team and therapeutic specialists as they identify the key milestones in the patient journey.
By collectively leveraging this information we are able to develop and put in place protocol-specific support solutions and patient engagement strategies for a more holistic, patient-centric approach and to drive the results you expect.
The outcome
Sites observed on average an increase 0.15 pts per site per month uplift in recruitment. Targets were met through increased referrals and on-site recruitment support.
Results of the implemented digital outreach campaign were successful with 69% of sites that were approached agreeing to participate and 88% of participating sites receiving at least one referral. The three month digital campaign period contributed to 28% of randomised subjects in participating countries. Notably the Netherlands approached 55% of subjects randomised. Cost per referral was also below projected and the SFR demonstrated that patients were good quality referrals.