Planned, ongoing and completed tuberculosis treatment trials in Brazil, Russia, India, China and South Africa: a 2019 cross-sectional descriptive analysis

Lindi Mathebula; Lovemore Mapahla; Dilyara Nurkhametova; Liliya Eugenevna Ziganshina; Mikateko Mazinu; Esme Jordan; Duduzile Edith Ndwandwe; Tamara Kredo

doi:10.1136/bmjopen-2021-057941

Planned, ongoing and completed tuberculosis treatment trials in Brazil, Russia, India, China and South Africa: a 2019 cross-sectional descriptive analysis

BMJ Open. 2022 Jun 9;12(6):e057941. doi: 10.1136/bmjopen-2021-057941.

Authors

Lindi Mathebula^{1

2}, Lovemore Mapahla^{2

3}, Dilyara Nurkhametova⁴, Liliya Eugenevna Ziganshina^{4

5}, Mikateko Mazinu³, Esme Jordan^{3

6}, Duduzile Edith Ndwandwe⁷, Tamara Kredo^{7

8}

Affiliations

¹ Cochrane South Africa, South African Medical Research Council, Tygerberg, South Africa lindi.mathebula@mrc.ac.za.
² Department of Global Health, Stellenbosch University, Tygerberg, South Africa.
³ Biostatistics Unit, South African Medical Research Council, Tygerberg, South Africa.
⁴ Cochrane Russia, Russian Medical Academy for Continuing Professional Education of the Ministry of Health, Moscow, Russian Federation.
⁵ Kazan Medical University and RUDN University, Moscow, Russian Federation.
⁶ Statistics and Population Studies Department, University of the Western Cape, Bellville, South Africa.
⁷ Cochrane South Africa, South African Medical Research Council, Tygerberg, South Africa.
⁸ Faculty of Medicine and Health Sciences, Division of Clinical Pharmacology, Department of Medicine, Stellenbosch University, Cape Town, South Africa.

Abstract

Tuberculosis (TB) remains a deadly challenge globally and Brazil, Russia, India, China and South Africa (BRICS) are among the countries with the highest TB burden. The objective of this study is to identify and describe ongoing, planned and completed TB trials conducted in the BRICS countries registered in WHO-International Clinical Trial Registry Platform (WHO-ICTRP); to report selective outcome reporting by comparing primary outcomes in published trials with their prespecified outcomes in registry records and to evaluate the time to publication.

Methods and analysis: We searched the WHO-ICTRP portal (20 January 2019) and the Russian Federation Registry (30 March 2019) to identify TB trials conducted in BRICS countries. We included only registered clinical trials conducted wholly in BRICS countries or with at least one recruitment centre in one of the BRICS countries that were investigating TB treatment.

Results: The search of the WHO-ICTRP yielded 408 trials and additional 32 trials were identified from the Russian registry. Of those, 253 were included in the analysis. We found that 77 trials were multicountry trials, followed by trials in China (55), India (53), South Africa (34), Russia (23) and Brazil (11). 163 trials were registered prospectively, 69 retrospectively and 21 trials had no registration status. Most trials (207) evaluated TB treatment, followed by 29 behaviour change interventions, 13 nutritional supplementation, 4 surgical treatment and 2 assessing rehabilitation. Based on ICJME recommendation of publishing 12 months after completion of trial, we found that 156 trials were completed 12 or more months by date and 101 trials had publications. Thirty-one of the 101 trials with publication had evidence of selective outcome reporting. The median time to publication was 25 months (IQR 15-37) from the time of anticipated end date stated in the registry.

Conclusion: TB trials conducted in BRICS countries are collaborative, mostly drug treatment oriented, potentially affecting policies. Selective outcome reporting remains a problem both for prospectively and retrospectively registered trials, only small fraction of which gets to publication.

Keywords: clinical trials; respiratory infections; tuberculosis.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Brazil
China / epidemiology
Clinical Trials as Topic
Cross-Sectional Studies
Humans
India / epidemiology
Russia
South Africa / epidemiology
Tuberculosis* / drug therapy
Tuberculosis* / epidemiology