Planned, ongoing and completed tuberculosis treatment trials in Brazil, Russia, India, China and South Africa: a 2019 cross-sectional descriptive analysis
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 o...
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| Format: | Article |
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e057941.full |
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| author | Tamara Kredo Duduzile Edith Ndwandwe Lindi Mathebula Lovemore Mapahla Dilyara Nurkhametova Liliya Eugenevna Ziganshina Mikateko Mazinu Esme Jordan |
| author_facet | Tamara Kredo Duduzile Edith Ndwandwe Lindi Mathebula Lovemore Mapahla Dilyara Nurkhametova Liliya Eugenevna Ziganshina Mikateko Mazinu Esme Jordan |
| author_sort | Tamara Kredo |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-81006f99afb74934b467ee0d05cd98d8 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-81006f99afb74934b467ee0d05cd98d82025-01-24T13:35:12ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-057941Planned, ongoing and completed tuberculosis treatment trials in Brazil, Russia, India, China and South Africa: a 2019 cross-sectional descriptive analysisTamara Kredo0Duduzile Edith Ndwandwe1Lindi Mathebula2Lovemore Mapahla3Dilyara Nurkhametova4Liliya Eugenevna Ziganshina5Mikateko Mazinu6Esme Jordan72 Division of Epidemiology and Biostatistics, Department of Global Health and Division of Clinical Pharmacology, Department of Medicine, Stellenbosch University Faculty of Medicine and Health Sciences, Cape Town, Western Cape, South Africa3 South African Medical Research Council, Tygerberg, South AfricaDepartment of Global Health, Stellenbosch University, Tygerberg, South AfricaDepartment of Global Health, Stellenbosch University, Tygerberg, South AfricaCochrane Russia, Russian Medical Academy for Continuing Professional Education of the Ministry of Health, Moscow, Russian FederationCochrane Russia, Russian Medical Academy for Continuing Professional Education of the Ministry of Health, Moscow, Russian FederationBiostatistics Unit, South African Medical Research Council, Tygerberg, South AfricaBiostatistics Unit, South African Medical Research Council, Tygerberg, South AfricaMethods 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.https://bmjopen.bmj.com/content/12/6/e057941.full |
| spellingShingle | Tamara Kredo Duduzile Edith Ndwandwe Lindi Mathebula Lovemore Mapahla Dilyara Nurkhametova Liliya Eugenevna Ziganshina Mikateko Mazinu Esme Jordan Planned, ongoing and completed tuberculosis treatment trials in Brazil, Russia, India, China and South Africa: a 2019 cross-sectional descriptive analysis BMJ Open |
| title | Planned, ongoing and completed tuberculosis treatment trials in Brazil, Russia, India, China and South Africa: a 2019 cross-sectional descriptive analysis |
| title_full | Planned, ongoing and completed tuberculosis treatment trials in Brazil, Russia, India, China and South Africa: a 2019 cross-sectional descriptive analysis |
| title_fullStr | Planned, ongoing and completed tuberculosis treatment trials in Brazil, Russia, India, China and South Africa: a 2019 cross-sectional descriptive analysis |
| title_full_unstemmed | Planned, ongoing and completed tuberculosis treatment trials in Brazil, Russia, India, China and South Africa: a 2019 cross-sectional descriptive analysis |
| title_short | Planned, ongoing and completed tuberculosis treatment trials in Brazil, Russia, India, China and South Africa: a 2019 cross-sectional descriptive analysis |
| title_sort | planned ongoing and completed tuberculosis treatment trials in brazil russia india china and south africa a 2019 cross sectional descriptive analysis |
| url | https://bmjopen.bmj.com/content/12/6/e057941.full |
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