scholarly journals Transparent reporting of recruitment and informed consent approaches in clinical trials recruiting children with minor parents in sub-Saharan Africa: a secondary analysis based on a systematic review

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Angela De Pretto-Lazarova ◽  
Domnita Oana Brancati-Badarau ◽  
Christian Burri
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Decision Maker ◽  
Secondary Analysis ◽  
Decision Makers ◽  
Sub Saharan Africa ◽  
Study Protocols ◽  
Sub Saharan

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.

scholarly journals INFORMED CONSENT IN CLINICAL TRIALS FOR PERSONS WITH DEMENTIA

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S28-S28 ◽  
Author(s):  
Joan G Carpenter
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Nursing Homes ◽  
Decision Maker ◽  
Surrogate Decision Maker ◽  
Decision Making Capacity ◽  
Consent Document ◽  
Surrogate Decision

Abstract Informed consent is one of the most important processes during the implementation of a clinical trial; special attention must be given to meeting the needs of persons with dementia in nursing homes who have impaired decision making capacity. We overcame several challenges during enrollment and consent of potential participants in a pilot clinical trial including: (1) the consent document was designed for legally authorized representatives however some potential participants were capable of making their own decisions; (2) the written document was lengthy yet all seven pages were required by the IRB; (3) the required legal wording was difficult to understand and deterred potential participants; and (4) the primary mode of communication was via phone. We tailored assent and informed consent procedures to persons with dementia and their legally authorized representative/surrogate decision maker to avoid risking an incomplete trial and to improve generalizability of trial results to all persons with dementia.

scholarly journals Cancer Clinical Trials in Africa—An Untapped Opportunity: Recommendations From AORTIC 2019 Conference Special Interest Group in Clinical Trials

2021 ◽  
pp. 1358-1363
Author(s):  
Abiola Ibraheem ◽  
Colin Pillai ◽  
Ifeoma Okoye ◽  
J. Joshua Smith ◽  
Diane Reidy-Lagunes ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sub Saharan Africa ◽  
Cancer Clinical Trials ◽  
Future Directions ◽  
Secondary Purpose ◽  
Health Care Burden ◽  
Sub Saharan ◽  
Cancer Disparity ◽  
And Training

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.

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 ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Health Research ◽  
Research Capacity ◽  
Communicable Diseases ◽  
National Institutes Of Health ◽  
Sub Saharan Africa ◽  
Sub Saharan ◽  
Fogarty International Center ◽  
Program Grant

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.

scholarly journals Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bassey Edem ◽  
Chukwuemeka Onwuchekwa ◽  
Oghenebrume Wariri ◽  
Esin Nkereuwem ◽  
Oluwatosin O. Nkereuwem ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Controlled Trial ◽  
Descriptive Analysis ◽  
Sub Saharan Africa ◽  
Trial Registration ◽  
Reporting Bias ◽  
Clinical Trial Registration ◽  
Cross Sectional ◽  
Sub Saharan

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.

scholarly journals Quality of clinical trials for selected priority mental and neurological disorders in sub-Saharan Africa: a systematic review

2016 ◽  
Vol Volume 8 ◽  
pp. 43-52
Author(s):  
Anwar Mulugeta ◽  
Girmay Medhin ◽  
Getnet Yimer ◽  
Rahimush Jemal ◽  
Abebaw Fekadu
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Neurological Disorders ◽  
Sub Saharan Africa ◽  
Sub Saharan

Khat chewing and risky sexual behavior in Sub-Saharan Africa: a systematic review protocol

2013 ◽  
Vol 11 (12) ◽  
pp. 59-67 ◽  
Author(s):  
Amanuel Tesfay Gebremedhin ◽  
Hailay Abrha Gesesew ◽  
Tariku Dejene Demissie ◽  
Mirkuzie Woldie Kerie ◽  
Morankar Sudhakar
Keyword(s):  
Systematic Review ◽  
Sexual Behavior ◽  
Risky Sexual Behavior ◽  
Sub Saharan Africa ◽  
Systematic Review Protocol ◽  
Khat Chewing ◽  
Review Protocol ◽  
Sub Saharan

scholarly journals Interventions to Ameliorate the Psychosocial Effects of the COVID-19 Pandemic on Children—A Systematic Review

2021 ◽  
Vol 18 (5) ◽  
pp. 2361
Author(s):  
Katharina Boldt ◽  
Michaela Coenen ◽  
Ani Movsisyan ◽  
Stephan Voss ◽  
Eva Rehfuess ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Health Management ◽  
Psychosocial Interventions ◽  
Well Being ◽  
World Health ◽  
Research Database ◽  
Psychosocial Effects ◽  
Global Database ◽  
Study Protocols

The aim of this study was to identify interventions targeting children and their caregivers to reduce psychosocial problems in the course of the COVID-19 pandemic and comparable outbreaks. The review was performed using systematic literature searches in MEDLINE, Embase, PsycINFO and COVID-19-specific databases, including the CDC COVID-19 Research Database, the World Health Organisation (WHO) Global Database on COVID-19 Research and the Cochrane COVID-19 Study Register, ClinicalTrials.gov, the EU Clinical Trials Register and the German Clinical Trials Register (DRKS) up to 25th September 2020. The search yielded 6657 unique citations. After title/abstract and full text screening, 11 study protocols reporting on trials planned in China, the US, Canada, the UK, and Hungary during the COVID-19 pandemic were included. Four interventions targeted children ≥10 years directly, seven system-based interventions targeted the parents and caregivers of younger children and adolescents. Outcome measures encompassed mainly anxiety and depressive symptoms, different dimensions of stress or psychosocial well-being, and quality of supportive relationships. In conclusion, this systematic review revealed a paucity of studies on psychosocial interventions for children during the COVID-19 pandemic. Further research should be encouraged in light of the expected demand for child mental health management.

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