Does South Africa need a national clinical trials support unit?

Siegfried, Nandi; Volmink, Jimmy; Dhansay, Ali

doi:10.7196/samj.3958

Cited by 17 publications

(19 citation statements)

References 9 publications

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“…This is similar to our previous study which also observed few funders from the continent [4]. Although White argues that international collaborations may be a vehicle for infrastructural development [33], when research is funded externally, researchers may become dependent on external sources, thereby potentially deflecting the priorities from the local needs [36], [37].…”

Section: Discussionsupporting

confidence: 89%

Randomized Controlled Trials of HIV/AIDS Prevention and Treatment in Africa: Results from the Cochrane HIV/AIDS Specialized Register

et al. 2011

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IntroductionTo effectively address HIV/AIDS in Africa, evidence on preventing new infections and providing effective treatment is needed. Ideally, decisions on which interventions are effective should be based on evidence from randomized controlled trials (RCTs). Our previous research described African RCTs of HIV/AIDS reported between 1987 and 2003. This study updates that analysis with RCTs published between 2004 and 2008.ObjectivesTo describe RCTs of HIV/AIDS conducted in Africa and reported between 2004 and 2008.MethodsWe searched the Cochrane HIV/AIDS Specialized Register in September 2009. Two researchers independently evaluated studies for inclusion and extracted data using standardized forms. Details included location of trials, interventions, methodological quality, location of principal investigators and funders.ResultsOur search identified 834 RCTs, with 68 conducted in Africa. Forty-three assessed prevention-interventions and 25 treatment-interventions. Fifteen of the 43 prevention RCTs focused on preventing mother-to-child HIV transmission. Thirteen of the 25 treatment trials focused on opportunistic infections. Trials were conducted in 16 countries with most in South Africa (20), Zambia (12) and Zimbabwe (9). The median sample size was 628 (range 33-9645). Methods used for the generation of the allocation sequence and allocation concealment were adequate in 38 and 32 trials, respectively, and 58 reports included a CONSORT recommended flow diagram. Twenty-nine principal investigators resided in the United States of America (USA) and 18 were from African countries. Trials were co-funded by different agencies with most of the funding obtained from USA governmental and non-governmental agencies. Nineteen pharmaceutical companies provided partial funding to 15 RCTs and African agencies co-funded 17 RCTs. Ethical approval was reported in 65 trials and informed consent in 61 trials.ConclusionPrevention trials dominate the trial landscape in Africa. Of note, few principal investigators and funders are from Africa. These findings mirror our previous work and continue to indicate a need for strengthening trial research capacity in Africa.

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Section: Discussionsupporting

confidence: 89%

Randomized Controlled Trials of HIV/AIDS Prevention and Treatment in Africa: Results from the Cochrane HIV/AIDS Specialized Register

et al. 2011

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“…There is considerable need to further develop national and regional clinical trials support units throughout the developing world. 5 …”

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confidence: 99%

Randomised trials in developing countries

Berkley

2014

Archives of Disease in Childhood

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“…15 The picture is no different globally. In a 2011 report published under the auspices of the Organization of Economic Co-operation and Development (OECD) Global Science Forum, stakeholders and experts from all over the world interviewed in a survey reported limited availability of accredited trial methodological training for members of the trial team, regardless of resource setting.…”

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confidence: 99%

Herbal medicine, randomised controlled trials and global core competencies

Siegfried

Hughes

2012

S Afr Med J

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Despite widespread use, few empirical data on the efficacy of traditional medicine are available. We conducted systematic reviews of eight widely used African medicines and identified only one plant, Pelargonium sidoides, which has been extensively studied (including in a Cochrane systematic review). To address the need for rigorous science to underpin traditional medicine claims, the South African Herbal Science and Medicine Institute at the University of Western Cape launched the Multi-disciplinary University Traditional Health Initiative (MUTHI) in 2011. The European Union-funded initiative aims to build sustainable research capacity on plants for better public health in Africa. A 2011 needs analysis of clinicians and scientists from 14 African countries confirmed a lack of clinical trial methodology, knowledge and experience. In response, MUTHI deliverables include annual clinical trial methodology workshops in host countries and development of e-learning modules. The initiative provides a unique opportunity for developing African capacity to discover new medicinal products.

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Does South Africa need a national clinical trials support unit?

Cited by 17 publications

References 9 publications

Randomized Controlled Trials of HIV/AIDS Prevention and Treatment in Africa: Results from the Cochrane HIV/AIDS Specialized Register

Randomized Controlled Trials of HIV/AIDS Prevention and Treatment in Africa: Results from the Cochrane HIV/AIDS Specialized Register

Randomised trials in developing countries

Herbal medicine, randomised controlled trials and global core competencies

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