Research

Publication trends of clinical trials performed in South Africa

Mncengeli Sibanda, R S Summers, J C Meyer

Abstract


Background. Investigators and sponsors of clinical trials have an ethical obligation to disseminate clinical trial results, whether positive or negative, in a timely manner.

Objectives. To determine the publication rate and average time to reporting for clinical trials carried out in South Africa (SA) and to explore factors indicating whether a study is published or not.

Methods. A registry-based quantitative retrospective analysis of 79 SA clinical trials for new medicines registered between January 2008 and December 2010 was performed. The relevant trial identification number in the register was used to track all peer-reviewed publications subsequent to registration. Tracking of clinical trials was done through a systematic literature search of the electronic journal databases of the South African Medical Journal (SAMJ), the Cochrane Library, Public Library of Science Medical Journal (PLoS Medicine) and BioMed Central, all of which are indexed on MEDLINE via PubMed. In addition, a manual search of the Open Access Journal of Clinical Trials databases and reference lists on articles related to the trial medicine was performed.

Results. Of the 79 clinical trials surveyed, 72 were concluded by December 2014. Only 35 (48.6%) of them had the results published in a peer-reviewed journal, the current benchmark for dissemination of trial results. The majority (82.9%) of those published had a positive outcome. Of the 35 trials that were published, 77.1% were published within 2 years. The average time from completion to initial reporting was 22 months. Fewer than half (40.5%) of the clinical trials surveyed were placebo controlled.

Conclusion. The absence of complete outcomes data from SA clinical trials warrants utmost attention. The study puts forward a case to the regulatory body and research ethics committees to compel all data from clinical trials to be made accessible to clinicians and the public in general by being published in an easily accessible form and in a timely manner. 



Authors' affiliations

Mncengeli Sibanda, Department of Pharmacy, Sefako Makgatho Health Sciences University, Ga-Rankuwa, Pretoria, South Africa; Inqaba Biotechnical Industries (Pty) Ltd, Pretoria, South Africa

R S Summers, Department of Pharmacy, Sefako Makgatho Health Sciences University, Ga-Rankuwa, Pretoria, South Africa

J C Meyer, Department of Pharmacy, Sefako Makgatho Health Sciences University, Ga-Rankuwa, Pretoria, South Africa

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Keywords

Clinical trials; Publication bias; Evidence-based medicine; Clinical trials registry; Register; Declaration of Helsinki; Good clinical practice; International Conference of Harmonisation; SANCTR; Medicines Control Council

Cite this article

South African Medical Journal 2016;106(5):519-523. DOI:10.7196/SAMJ.2016.v106i5.9952

Article History

Date submitted: 2015-09-12
Date published: 2016-04-19

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