Publications

Funding for clinical research |drugs, vaccines, microbicides, diagnostics | HIV/AIDS, tuberculosis, malaria, other infectious diseases |sub-Saharan Africa

EDCTP portfolio: Clinical Research & Development Fellowships

Dr Suzanne Staples pursued expertise in advanced phase clinical trials at Julius Clinical, the Netherlands, then conducting an intensive quality and training project at the THINK organisation in South Africa.

Getting to quality clinical trial services

The challenge for many early-career researchers is to hone their skills and experience in clinical product R&D. The EDCTP clinical R&D fellowships allow fellows to do just that through a placement in a clinical research organisation. Dr Staples aimed especially to familiarise herself with all the requirements for phase III/IV clinical trials and other study designs such as pragmatic trials and real-world observational studies.

The challenge

Dr Staples has a background in medicine and started to work as a research clinician in 2012; she completed a Master’s in Transdisciplinary Health and Development Studies from Stellenbosch University. Since 2012, she participated in several TB and HIV clinical trials. Working at THINK (TB and HIV Investigative Network, Durban, KwaZulu-Natal, South Africa) she was promoted to Principal investigator in 2013 and conducted multiple phase II and III trials, which were conducted in collaboration with sponsors such as TB Alliance, MRC UK, and pharmaceutical industry.

Her placement at Julius Clinical, the Netherlands immersed her in the operation of this scientific clinical research organisation. She was able to train on all aspects of phase III/IV clinical trials, from proposal writing to reporting and manuscript preparation, from design and protocol development, site selection and initiation, trial management (including GCP and data-management) to monitoring and pharmacovigilance. 

The project

Besides preparing her for the next step in her career as a researcher (developing her own research project and successfully apply for funding), the immediate impact at THINK, her home institution, will be an extensive training and role development programme for all staff in combination with revisiting and developing guidelines and standard operating procedures and reviewing the conditions and key requirements of quality service. She also envisages developing an African research network.

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 challenge for many early-career researchers is to hone their skills and experience in clinical product R&D. The EDCTP clinical R&D fellowships allow fellows to do just that through a placement in a clinical research organisation. Dr Staples aimed especially to familiarise herself with all the requirements for phase III/IV clinical trials and other study designs such as pragmatic trials and real-world observational studies.

Dr Staples has a background in medicine and started to work as a research clinician in 2012; she completed a Master’s in Transdisciplinary Health and Development Studies from Stellenbosch University. Since 2012, she participated in several TB and HIV clinical trials. Working at THINK (TB and HIV Investigative Network, Durban, KwaZulu-Natal, South Africa) she was promoted to Principal investigator in 2013 and conducted multiple phase II and III trials, which were conducted in collaboration with sponsors such as TB Alliance, MRC UK, and pharmaceutical industry.

Her placement at Julius Clinical, the Netherlands immersed her in the operation of this scientific clinical research organisation. She was able to train on all aspects of phase III/IV clinical trials, from proposal writing to reporting and manuscript preparation, from design and protocol development, site selection and initiation, trial management (including GCP and data-management) to monitoring and pharmacovigilance. 

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.

Besides preparing her for the next step in her career as a researcher (developing her own research project and successfully apply for funding), the immediate impact at THINK, her home institution, will be an extensive training and role development programme for all staff in combination with revisiting and developing guidelines and standard operating procedures and reviewing the conditions and key requirements of quality service. She also envisages developing an African research network.

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