Abstract

BackgroundThere is both higher mortality and morbidity from cancer in low and medium income countries (LMICs) compared with high income countries (HICs). Clinical trial activities and development of more effective and less toxic therapies have led to significant improvements in morbidity and mortality from cancer in HICs. Unfortunately, clinical trials remain low in LMICs due to poor infrastructure and paucity of experienced personnel to execute clinical trials. There is an urgent need to build local capacity for evidence-based treatment for cancer patients in LMICs.MethodsWe conducted a survey at facilities in four Teaching Hospitals in South West Nigeria using a checklist of information on various aspects of clinical trial activities. The gaps identified were addressed using resources sourced in partnership with investigators at HIC institutions.ResultsDeficits in infrastructure were in areas of patient care such as availability of oncology pharmacists, standard laboratories and diagnostic facilities, clinical equipment maintenance and regular calibrations, trained personnel for clinical trial activities, investigational products handling and disposals and lack of standard operating procedures for clinical activities. There were two GCP trained personnel, two study coordinators and one research pharmacist across the four sites. Interventions were instituted to address the observed deficits in all four sites which are now well positioned to undertake clinical trials in oncology. Training on all aspects of clinical trial was also provided.ConclusionsPartnerships with institutions in HICs can successfully identify, address, and improve deficits in infrastructure for clinical trial in LMICs. The HICs should lead in providing funds, mentorship, and training for LMIC institutions to improve and expand clinical trials in LMIC countries.

Highlights

  • There is both higher mortality and morbidity from cancer in low and medium income countries (LMICs) compared with high income countries (HICs)

  • Engagement of stake holders We first engaged with stakeholders, key opinion leaders, policy makers such as departmental heads, Chief Medical Directors (CMDs) of four hospitals, Provosts of two Colleges of Medicine, Commissioners for health, Governors of two states who were associated with selected hospitals and the Federal Ministry of Health

  • Hoffmann-La Roche & Co Switzerland. These organizations supported the concept in order to assist in improving clinical trial infrastructure that will enable clinical trials led by indigenous researchers to be conducted in sub-Saharan Africa (SSA). This is based on the premise that the best way to increase the conduct of clinical trials in SSA is to train local investigators and improve facilities whereby they will be involve in designing and conducting studies that will be relevant to the population

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Summary

Introduction

There is both higher mortality and morbidity from cancer in low and medium income countries (LMICs) compared with high income countries (HICs). Clinical trial activities and development of more effective and less toxic therapies have led to significant improvements in morbidity and mortality from cancer in HICs. clinical trials remain low in LMICs due to poor infrastructure and paucity of experienced personnel to execute clinical trials. There is an urgent need to build local capacity for evidence-based treatment for cancer patients in LMICs. Cancer, once considered the disease of high income countries (HIC), has slowly become endemic in low income countries (LMIC). Despite the significant link to African Americans in the US, there are few clinical trials conducted in Sub-Saharan Africa [12,13,14] (Fig. 1)

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