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Using Research Capacity Enhancement to Develop and Implement National Standard-of-Care Treatment Protocols in
Mohiba A Khowaja1, Alia Ahmad2, Sadaf Altaf3
1Pakistan Society of Pediatric Oncology (PSPO), Karachi, Pakistan.
Insights
The Pakistan Society of Pediatric Oncology (PSPO) successfully implemented national standard-of-care (SOC) protocols for childhood cancer, improving research infrastructure in Pakistan. This initiative demonstrates feasibility for low-resource settings.
Area of Science:
- Oncology
- Clinical Research
- Public Health
Background:
- Clinical research methodology is vital for improving pediatric cancer outcomes.
- The World Health Organization's Global Initiative for Childhood Cancer (GICC) aims to improve childhood cancer care globally.
- Pakistan faces challenges in pediatric cancer treatment due to resource limitations.
Purpose of the Study:
- To describe the strategy for developing and implementing national standard-of-care (SOC) protocols for pediatric cancer in Pakistan.
- To establish a centralized research and data management support system.
- To lay the foundation for future advancements in pediatric cancer care within Pakistan.
Main Methods:
- A central Pakistan Society of Pediatric Oncology (PSPO) office provided support for protocol development and data management.
- Multi-institutional teams developed SOC protocols based on international evidence and local data for six GICC-targeted diagnoses.
- RedCap software was used for case report forms and databases, with comprehensive training and ongoing data quality maintenance through audits and analyses.
Main Results:
- Protocol development and implementation were completed within 26 months.
- Each protocol is active in at least seven centers, with nearly 2,000 patients enrolled.
- Interim analysis of Acute Lymphoblastic Leukemia (ALL) data indicated 85% data accuracy.
Conclusions:
- Implementing multi-institutional treatment protocols is feasible in low- and middle-income countries with limited resources.
- Building research infrastructure and capacity is achievable through collaborative efforts.
- The PSPO's approach provides a scalable model for improving pediatric cancer care in resource-constrained settings.
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.
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