Using Research Capacity Enhancement to Develop and Implement National Standard-of-Care Treatment Protocols in Pakistan.

Purpose: Utilization of clinical research methodology as a means for improvement in pediatric cancer outcomes is well established. Toward achievement of its WHO-Global Initiative for Childhood Cancer (GICC) goals in Pakistan, the Pakistan Society of Pediatric Oncology (PSPO) has used this methodology to develop and implement standard-of-care (SOC) protocols nationally, with centralized research and data management support. This article describes the strategy for its implementation and provides a foundation for future advancements in cancer care in Pakistan.

Methods: The following steps were used to achieve the objectives: Central Support: A central PSPO office was established with minimal required staffing for provision of support to clinicians for protocol development and implementation and housing data and documents. Clinical protocols: multi-institutional teams, supported by central staff, developed SOC protocols on the basis of international evidence and local experience for six GICC target diagnoses. These went through an iterative consultation and revision process and were finally approved by the PSPO Board. Protocol implementation: case report forms and databases were developed using RedCap software and tested for functionality. Education and training were provided to institutional principal investigators and data entry personnel on the disease, protocol, use of RedCap, and data entry. Data quality maintenance: a system was established for ongoing data quality maintenance through central support and augmented by virtual and on-site audits. Where required, targeted training was provided. Interim analyses are being performed to assess data quality and early outcomes.

Results: Development and implementation of protocols occurred over 26 months. Each protocol is currently active in at least seven centers. Almost 2,000 patients have been enrolled. Interim analysis of ALL data shows 85% data accuracy.

Conclusion: Research infrastructure and capacity building for implementation of multi-institutional treatment protocols in low- and middle-income countries with modest resources is feasible.