A large multinational pharmaceutical company partnered with ICON on a Phase 2b study to assess the efficacy of early switching from one oral treatment to another oral treatment for chronic phase chronic myeloid leukemia (CP-CML) after less than optimal response to the first oral treatment. The study had a screening fail rate of over 75%, screening over 1100 patients age 18+ with CP-CML to randomise 260 patients to treatment, from 98 sites across 15 countries in North America, Latin America, Europe, and Asia. The study faced challenges of delayed site start-up, particularly in China and Brazil where initial regulatory and ethic approvals exceeded 12 months. The delayed recruitment from sites in these countries impacted global recruitment because the prescribing standard of care in these countries lent specifically to the inclusion criteria of the study. The study had multiple protocol iterations, operating under the seventh version at time of enrolment close.

ICON and the sponsor worked closely on multiple approaches to boost recruitment activity in a challenging indication with a high screen fail rate.

• In collaboration with the ICON Patient Enrolment and Retention group, the study team developed print recruitment materials for site staff and patients, including study posters, investigator brochures, inclusion/exclusion cards, mini protocols, doctor-to-doctor referral letters, patient brochures, and patient visit cards.
• Site monitors conducted booster visits with all active sites, combining pointed re-engagement and recruitment discussions with regular monitoring activities.
• ICON distributed quarterly newsletters to sites emphasising the criticality of continued recruitment and, as enrolment was nearing the end, challenged all sites to screen 1 additional patient within the next 1.5 months.
• Regional medical monitors conducted doctor-to-doctor communications with investigators to discuss potential recruitment challenges and eligibility concerns.
• ICON partnered with the sponsor to draft recruitment communication.
• The sponsor medical monitor sent a recruitment communication to all active sites to encourage continued screening activity as paramount to study success.
• Sponsor representatives in China visited 5 sites and called 13 sites to encourage continued recruitment, as China ultimately contributed approximately 65% of the study recruitment.
• Site monitors worked closely with sites to track pre-identified patients for screening and dates so that these patients could be followed; with recruitment updates provided in weekly status reporting.
• Project manager proactively managed patient accrual projections, incorporating country-specific enrolment rates to identify timeline risks and develop contingencies.
• As the study neared its enrolment goal, blast communications were sent to sites to count down open screening and enrolment positions and clearly state timeline expectations.

As a result of the multifaceted communication approach with sites and a strong partnership between ICON and sponsor, the study met its protocol-specified enrolment goal just 9 days beyond contracted Last Patient In date (LPI).