Case Study: Global Breast Cancer
Six months ahead of schedule in global Breast Cancer study
This global Phase IIIb study for breast cancer leveraged local cultural knowledge, efficient monitoring andstrong site communications to exceed its challenging recruitment goals, enrolling over 4,000 patients across20 countries in the Asia/Pacific, North America, Europe and the Middle East.
PAREXEL was responsible for site selection, qualification and initiation; investigator meeting coordination; clinical monitoring (including central, remote and on-site monitoring); data management; and project management.
Key challenges and solutions
• Ensuring cultural sensitivity to support successful patient recruitment – Multi-national breast cancer studies require heightened sensitivity in the recruitment stage because of the cultural issues surrounding breast cancer treatment around the world. These sensitivities can be particularly acute in some Asian countries, such as Japan. To overcome these challenges, PAREXEL drew on its extensive global trial experience to assemble a study team with a deep understanding of the medical practices, cultural norms and regulatory differences of the countries involved in study. As a result, the overall patient recruitment goal was achieved within two years – six months ahead of schedule.
• Maximizing site monitoring efficiency – PAREXEL initiated a site monitoring plan to maximize the efficiency of study operations while controlling costs. Centralized monitoring was established for monthly site contacts in North America, supplemented by on-site monitoring. A remote monitoring model was implemented for sites in Europe and the rest of the world (except Japan), with local CRAs performing site contacts and visits. A system of telephone contacts using a prepared script was utilized to review key site performance indicators such as recruitment, confirmation of consent for new patients, and CRF issues. The CTMS provided a report of these contacts for central review. This system reduced the required on-site visits for most locations to three over the course of the five-year study. Sites in Japan received additional on-site monitoring visits to ensure that cultural issues were being addressed appropriately.
• Maintaining site performance and interest – A robust exchange of information between the sites, the sponsor and PAREXEL was essential to maintain site performance levels and handle issues on a timely basis. Local PAREXEL affiliates and CRAs worked together to develop on-going communications plans tailored to country-specific requirements and study periods. Flexibility in local contracting also allowed for additional site visits and investigator payments where specific needs were identified. A monthly newsletter was sent to each site to communicate helpful tips, information about new procedures, answers to frequent queries, and recruitment status. Quarterly meetings were held to identify common queries that could be managed centrally to reduce site workloads.
Despite the wide diversity of sites and the cultural challenges of recruiting patients for breast cancer, the study milestones for First Patient In, Site Initiation, and Patients Recruitment were all achieved on schedule. More important, the overall patient recruitment goal was achieved within two years – six months ahead of schedule.