EDCTP portfolio: Clinical Research & Development Fellowships

Dr Alice Matimba broadened her skills in epidemiology and clinical research at Merck KGaA, with a focus on comorbidities of infectious and non-communicable diseases in Zimbawe.

Surveilling and managing disease comorbidities

The main goal of the placement at Merck KGaA was to acquire proficiency in clinical trial design and operations.

The challenge

First, Dr Matimba was mentored by the Director Early Stage Clinical Operations, and the Head of Financial Performance, Planning & Analysis who provided her with many opportunities to learn about clinical trial management, clinical trials operations and study implementation, finance and forecasting, KPIs and benchmarking, and project management systems.

Then, under the guidance of a Senior Clinical Research Manager, she was given specific tasks on the study ENCORE, an observational trial for recurrent metastatic head and neck cancer and the use of Erbitux®(cetuximab) which is being conducted in five countries. Dr Matimba had the opportunity to oversee some activities including protocol amendments, drug safety and SAE reporting, data management, risk assessment, SAP, interim snapshot analysis and conference abstract preparation. This involved regular interactions with the Medical Affairs, Drug Safety and Data Management departments as well as the CROs. After the introduction to the trial and the team, she was given team leadership for an interim analysis of this trial.

Discussions at Merck also showed agreement that there is a need to increase awareness of diabetes and conduct observational and clinical trials on this disease. In future, partnerships could be developed with local health authorities and NGOs to support screening programmes and to include African populations in future observational trials which could expand the market for current drugs.

The project

In collaboration with another EDCTP Fellow, Dr Isidore Traore (Burkina Faso), Dr Matimba proposed to assess capacity in Zimbabwe for conducting clinical trials on immunology, oncology and endocrinology, which are focus areas for Merck. A questionnaire-based survey was developed and will be piloted at the home institutions in Burkina Faso and Zimbabwe. They anticipate publication and potentially the development of an electronic database.

The Merck Capacity Advancement Programme (CAP) aims to build clinical research capacity in Africa. During her time at Merck, Dr Matimba had the opportunity to explore the possibilities of the CAP programme and indicate interest on behalf of her institution, especially to address noncommunicable diseases such as diabetes and cancer against a background of infectious diseases. Such health challenges need to be tackled in a combined manner. Non-communicable diseases are currently neglected as regards surveillance, management and availability of medicines. Areas of common interest with the Merck programme were clearly identified.

Impact


test the safety and efficacy of this new formulation in young children

Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

EDCTP portfolio: HIV & HIV-associated infections

The challenge

The main goal of the placement at Merck KGaA was to acquire proficiency in clinical trial design and operations.

First, Dr Matimba was mentored by the Director Early Stage Clinical Operations, and the Head of Financial Performance, Planning & Analysis who provided her with many opportunities to learn about clinical trial management, clinical trials operations and study implementation, finance and forecasting, KPIs and benchmarking, and project management systems.

Then, under the guidance of a Senior Clinical Research Manager, she was given specific tasks on the study ENCORE, an observational trial for recurrent metastatic head and neck cancer and the use of Erbitux®(cetuximab) which is being conducted in five countries. Dr Matimba had the opportunity to oversee some activities including protocol amendments, drug safety and SAE reporting, data management, risk assessment, SAP, interim snapshot analysis and conference abstract preparation. This involved regular interactions with the Medical Affairs, Drug Safety and Data Management departments as well as the CROs. After the introduction to the trial and the team, she was given team leadership for an interim analysis of this trial.

Discussions at Merck also showed agreement that there is a need to increase awareness of diabetes and conduct observational and clinical trials on this disease. In future, partnerships could be developed with local health authorities and NGOs to support screening programmes and to include African populations in future observational trials which could expand the market for current drugs.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

In collaboration with another EDCTP Fellow, Dr Isidore Traore (Burkina Faso), Dr Matimba proposed to assess capacity in Zimbabwe for conducting clinical trials on immunology, oncology and endocrinology, which are focus areas for Merck. A questionnaire-based survey was developed and will be piloted at the home institutions in Burkina Faso and Zimbabwe. They anticipate publication and potentially the development of an electronic database.

The Merck Capacity Advancement Programme (CAP) aims to build clinical research capacity in Africa. During her time at Merck, Dr Matimba had the opportunity to explore the possibilities of the CAP programme and indicate interest on behalf of her institution, especially to address noncommunicable diseases such as diabetes and cancer against a background of infectious diseases. Such health challenges need to be tackled in a combined manner. Non-communicable diseases are currently neglected as regards surveillance, management and availability of medicines. Areas of common interest with the Merck programme were clearly identified.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact

L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.

Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.

WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.

WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing

HIV infection: Recommendations for a public health approach
(second edition). 2016

Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3

Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)

Target population(s): Children with HIV

Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)

Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)

Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)

EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)

Total project funding: €1.2M (CHAPAS-1); €5.0M

About us

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public–public partnership between 14 European and 16 African countries, supported by the European Union. EDCTP’s vision is to reduce the individual, social and economic burden of poverty-related infectious diseases by affecting sub-Saharan Africa. EDCTP’s mission is to accelerate the development of new or improved medicinal products for the identification, treatment and prevention of infectious diseases, including emerging and re-emerging diseases, through pre- and postregistration clinical studies, with emphasis on phase II and III clinical trials. Our approach integrates conduct of research with development of African clinical research capacity and networking. The second EDCTP programme is implemented by the EDCTP Association supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

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