scholarly journals Advancing collaborations in health research and clinical trials in Sub-Saharan Africa: development and implementation of a biostatistical collaboration module in the Masters in Biostatistics Program at Stellenbosch University

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Tonya M. Esterhuizen ◽  
Guowei Li ◽  
Taryn Young ◽  
Jie Zeng ◽  
Rhoderick Machekano ◽  
...  

Abstract Background Sub-Saharan Africa continues to carry a high burden of communicable diseases such as TB and HIV and non-communicable diseases such as hypertension and other cardiovascular conditions. Although investment in research has led to advances in improvements in outcomes, a lot still remains to be done to build research capacity in health. Like many other regions in the world, Sub-Saharan Africa suffers from a critical shortage of biostatisticians and clinical trial methodologists. Methods Funded through a Fogarty Global Health Training Program grant, the Faculty of Medicine and Health Sciences at Stellenbosch University in South Africa established a new Masters Program in Biostatistics which was launched in January 2017. In this paper, we describe the development of a biostatistical and clinical trials collaboration Module, adapted from a similar course offered in the Health Research Methodology program at McMaster University. Discussion Guided by three core principles (experiential learning; multi-/inter-disciplinary approach; and formal mentorship), the Module aims to advance biostatistical collaboration skills of the trainees by facilitating learning in how to systematically apply fundamental statistical and trial methodological knowledge in practice while strengthening some soft skills which are necessary for effective collaborations with other healthcare researchers to solve health problems. We also share some preliminary findings from the first four cohorts that took the Module in January–November 2018 to 2021. We expect that this Module can provide an example of how to improve biostatistical and clinical trial collaborations and accelerate research capacity building in low-resource settings. Funding source Fogarty International Center of the National Institutes of Health.

2021 ◽  
pp. 1358-1363
Author(s):  
Abiola Ibraheem ◽  
Colin Pillai ◽  
Ifeoma Okoye ◽  
J. Joshua Smith ◽  
Diane Reidy-Lagunes ◽  
...  

Cancer is now a formidable health care burden in sub-Saharan Africa (SSA) due to lifestyle westernization and longer life expectancy. The exponential increase in cancer incidence coupled with high mortality rate is not comparable with that seen in westernized countries. To address global cancer disparity, globalization of cancer clinical trials to involve sub-Saharan Africa can serve as a platform where innovative targeted therapies can be made available to patients in the environ. In the 2019 African Organization for Research and Training in Cancer (AORTIC) conference held at Maputo, Mozambique, a group of clinical trialists spanning across multiple continents highlighted the opportunities in Africa for the conduct of cancer clinical trials. The secondary purpose of the meeting was to address the belief that Africa was incapable of conducting interventional cancer trials but showed the in-continent strengths, such as available capacities, trained local clinical trialists with clinical trial experiences, clinical trial consortia, local capabilities, mapping out logistics, ethical consideration, political will, real-time benefits of clinical trials to clinical practice, and future directions for trials.


2020 ◽  
Vol 7 ◽  
Author(s):  
Dixon Chibanda ◽  
Melanie Abas ◽  
Rosemary Musesengwa ◽  
Chris Merritt ◽  
Katherine Sorsdahl ◽  
...  

Abstract Mental, neurological and substance use (MNS) disorders are a leading, but neglected, cause of morbidity and mortality in sub-Saharan Africa. The treatment gap for MNS is vast with only 10% of people with MNS disorders in low-income countries accessing evidence-based treatments. Reasons for this include low awareness of the burden of MNS disorders and limited evidence to support development, adaptation and implementation of effective and feasible treatments. The overall goal of the African Mental Health Research Initiative (AMARI) is to build an African-led network of MNS researchers in Ethiopia, Malawi, South Africa and Zimbabwe, who are equipped to lead high quality mental health research programs that meet the needs of their countries, and to establish a sustainable career pipeline for these researchers with an emphasis on integrating MNS research into existing programs such as HIV/AIDS. This paper describes the process leading to the development of AMARI's objectives through a theory of change workshop, successes and challenges that have been faced by the consortium in the last 4 years, and the future role that AMARI could play in further building MNS research capacity by brining on board more institutions from low- and middle-income countries with an emphasis on developing an evidence-based training curriculum and a research-driven care service.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Angela De Pretto-Lazarova ◽  
Domnita Oana Brancati-Badarau ◽  
Christian Burri

Abstract Background Standardised checklists of items to be addressed in clinical study protocols and publications are promoting transparency in research. However, particular specifications for exceptional cases, such as children with minor parents are missing. This study aimed to examine the level of transparency regarding recruitment and informed consent approaches in publications of clinical trials recruiting children with minor parents in sub-Saharan Africa. We thereby focused particularly on the transparency about consenting persons (i.e. proxy decision-makers) and assessed the need to expand reporting guidelines for such exceptional cases. Methods We conducted a secondary analysis of clinical trial publications previously identified through a systematic review. Multiple scientific databases were searched up to March 2019. Clinical trial publications addressing consent and potentially recruiting children with minor parents in sub-Saharan Africa were included. 44 of the in total 4382 screened articles met our inclusion criteria. A descriptive analysis was performed. Results None of the included articles provided full evidence on whether any recruited children had minor parents and how consent was obtained for them. Four proxy decision-maker types were identified (parents; parents or guardians; guardians; or caregivers), with further descriptions provided rarely and mostly in referenced clinical trial registrations or protocols. Also, terminology describing proxy decision-makers was often used inconsistently. Conclusions Reporting the minimum maternal age alongside maternal data provided in baseline demographics can increase transparency on the recruitment of children with minor mothers. The CONSORT checklist should require clinical trial publications to state or reference exceptional informed consent procedures applied for special population groups. A standardized definition of proxy decision-maker types in international clinical trial guidelines would facilitate correct and transparent informed consent for children and children with minor parents. Study registration CRD42018074220.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bassey Edem ◽  
Chukwuemeka Onwuchekwa ◽  
Oghenebrume Wariri ◽  
Esin Nkereuwem ◽  
Oluwatosin O. Nkereuwem ◽  
...  

Abstract Objective Prospective registration of clinical trials is an ethical, scientific, and legal requirement that serves several functions, including minimising research wastage and publication bias. Sub-Saharan Africa (SSA) is increasingly hosting clinical trials over the past few years, and there is limited literature on trends in clinical trial registration and reporting in SSA. Therefore, we set out to determine the trends in clinical trials registered in SSA countries between 2010 and July 2020. Methods A cross-sectional study design was used to describe the type of clinical trials that are conducted in SSA from 1 January 2010 to 31 July 2020. The registries searched were ClinicalTrials.gov (CTG), the Pan African Clinical Trials Register (PACTR), and the International Standard Randomized Controlled Trial Number (ISRCTN). Data were extracted into Excel and imported into STATA for descriptive analysis. Results CTG had the highest number of registered trials at 2622, followed by PACTR with 1501 and ISRCTN with 507 trials. Trials were observed to increase gradually from 2010 and peaked at 2018–2019. Randomised trials were the commonest type, accounting for at least 80% across the three registries. Phase three trials investigating drugs targeted at infections/infestations were the majority. Few completed trials had their results posted: 58% in ISRCTN and 16.5% in CTG, thus suggesting reporting bias. Conclusion Despite the gradual increase in clinical trials registered during the period, recent trends suggest a drop in the number of trials registered across the region. Strengthening national and regional regulatory capacity will improve clinical trial registration and minimise reporting bias in completed clinical trials.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Adamson S. Muula ◽  
Mina C. Hosseinipour ◽  
Martha Makwero ◽  
Johnstone Kumwenda ◽  
Prosper Lutala ◽  
...  

AbstractThe Malawi College of Medicine and its partners are building non-communicable diseases’ (NCDs’) research capacity through a grant from the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health. Several strategies are being implemented including research mentorship for junior researchers interested to build careers in NCDs’ research. In this article, we present the rationale for and our experiences with this mentorship program over its 2 years of implementation. Lessons learned and the challenges are also shared.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Neema Toto ◽  
Elaine Douglas ◽  
Markus Gmeiner ◽  
Lynn K. Barrett ◽  
Robert Lindblad ◽  
...  

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