Article type
Year
Abstract
Background: Thirty-four per cent of tuberculosis (TB)-related deaths occur in Africa. Among people living with HIV, at least one in four deaths can be attributed to TB, often in resource-limited settings. The Pan African Clinical Trials Registry (PACTR), the only African member of the World Health Organization’s (WHO) Primary Registry Network, contributes to WHO’s International Clinical Trial Registry Platform’s (ICTRP) central database of clinical trials as well as initiatives to strengthen regulatory and research frameworks by providing a venue and support for trial registration. This study describes the status of TB trials registered on PACTR and the WHO-ICTRP.
Objectives: To analyse TB interventions trials conducted in Africa and registered on PACTR and WHO-ICTRP.
Methods: We searched PACTR and WHO-ICTRP for trials of TB interventions. Data extraction included the number of trials, their location, intervention studied, principal investigator's (PI) location, participant age range and funder. Descriptive analysis was run in MS Excel.
Results:There are 430 studies registered on PACTR, with 44 trials reporting planned or ongoing TB research. On ICTRP 173 intervention trials were found as well as 25 TB-related observational studies. Twenty-four PACTR trials explored treatment, seven diagnosis, five prevention trials included two vaccines, four education and counselling, and two supportive care interventions. Sample sizes range from 12 to 27 000. Twenty-one trials were single-centred in 10 countries; 23 multi-centre trials in 10 African countries; 38 PIs are African, one trial had multiple PIs - nine from Europe and USA. Nine trials received funding from the European and Developing Countries Clinical Trials Partnership (EDCTP); none were industry funded. Further analysis to include and compare with trials registered on WHO-ICTRP is ongoing.
Conclusions: As PACTR registrations increase, the registry will become a tool for regulatory and funding bodies to monitor the changing TB trial landscape in Africa. Both PACTR and WHO-ICTRP are valuable resources for systematic review authors to identify ongoing TB trials, and also potential new review titles.
Objectives: To analyse TB interventions trials conducted in Africa and registered on PACTR and WHO-ICTRP.
Methods: We searched PACTR and WHO-ICTRP for trials of TB interventions. Data extraction included the number of trials, their location, intervention studied, principal investigator's (PI) location, participant age range and funder. Descriptive analysis was run in MS Excel.
Results:There are 430 studies registered on PACTR, with 44 trials reporting planned or ongoing TB research. On ICTRP 173 intervention trials were found as well as 25 TB-related observational studies. Twenty-four PACTR trials explored treatment, seven diagnosis, five prevention trials included two vaccines, four education and counselling, and two supportive care interventions. Sample sizes range from 12 to 27 000. Twenty-one trials were single-centred in 10 countries; 23 multi-centre trials in 10 African countries; 38 PIs are African, one trial had multiple PIs - nine from Europe and USA. Nine trials received funding from the European and Developing Countries Clinical Trials Partnership (EDCTP); none were industry funded. Further analysis to include and compare with trials registered on WHO-ICTRP is ongoing.
Conclusions: As PACTR registrations increase, the registry will become a tool for regulatory and funding bodies to monitor the changing TB trial landscape in Africa. Both PACTR and WHO-ICTRP are valuable resources for systematic review authors to identify ongoing TB trials, and also potential new review titles.