ID #874 Collaborative approaches to improve clinical research operations in pediatric neuro-oncology in upper to lower-middle income countries
Heather Roemerman, Sally Jones, Catie Knoerle, Mohamed AbdelbakiAbstract
Background
Creating a successful clinical research office (CRO) requires significant resources. Knowledgeable staff, dedicated research time, reliable funding, and technology are some of the main elements to build capacity for a successful CRO. Our goal is to understand how our affiliates in upper and lower middle-income countries (UMIC, LMIC) operate.
Methods
A survey was sent to 9 academic institutions in Brazil, 1 in Egypt and 1 in Jordan to understand infrastructure, clinical trial portfolio, training in regulations, and staffing. We also conducted a journal search to identify challenges in UMIC and LMIC. Follow-up interviews will be conducted to gain more context and ideas for collaboration, and these results will be presented during the ISPNO meeting.
Results
We received 11 survey responses, which showed commonalities of the organization of the CRO such as the presence of an institutional IRB and use of electronic programs to store data. All sites participate in a range of phase 1 to phase 4 trials. Differences were reported in terms of funding, language of records, and types of clinical trial participation. Institutions in Egypt and Jordan are charity or NGO funded,while centers in Brazil are academic or public/government funded. Only Jordan and 2 centers in Brazil kept records in English. Sites in Brazil participate in more therapeutic trials than sites in Egypt and Jordan. Overall, sites in each country indicate having a research team; although, primarily consisting of the PI and clinical level staff rather than clinical research coordinators.
Conclusions
We learned the two main challenges of CRO management in UMICs and LMICs are staffing for dedicated research time and funding. Our CRO has extensive experience, standard procedures, and templates we can share with our international partners. We plan to follow-up with these sites to uncover opportunities for collaboration to improve clinical research operations with our global partners.