Article type
Year
Abstract
Background:
A clinical trials registry is a database in which key administrative and scientific information about planned, ongoing and completed trials is stored. The Pan African Clinical Trials Register (PACTR) aims to assist regional efforts towards transparency and harmonization of clinical trial research, by promoting prospective clinical trial registration and providing a venue to register and search the database of African clinical trials.
Objectives:
To describe and report on the first 1000 African controlled clinical trials registered in PACTR.
Methods:
This is a cross-sectional study. We extracted data for the first 1000 trials registered in PACTR to Excel. Data fields included intervention, condition, participant age, country, sample size, ethics, country of principal investigator, funders, number of sites. We conducted descriptive analysis using Stata software and generated frequency tables.
Results:
We found 757 (76%) single-center studies, for which the most common countries of registration were Egypt 430 (56.8%), followed by South Africa 75 (9.9%), and Kenya 45 (5.94%). Most of the trials (80%) were conducted in adults. Median sample size was 98 with an interquartile range of 52 to 240. Funding was most often from a University (37%), 14.4% were self funded, 13.9% government funded and 6.7% were funded by the European & Developing Countries Clinical Trials Partnership (EDCTP). A quarter of registered trials were in infectious and parasitic diseases, followed by pregnancy and childbirth (6%). Drug therapies were the intervention in 258 (26%) trials, 176 (18%) were prevention interventions, and 41 (4%) were diagnostic trials. Half of the trials (50%) were prospectively registered. Ethics approval was available for 893 trials (89%).
Conclusions:
Registration on PACTR continues to grow since 2009. The conditions investigated reflect the local burden of disease in infectious diseases and maternal-child health. University funding is commonly reported, indicating that PACTR is a platform for trial registration by local researchers. Given the high percentage of retrospectively registered trials, there is still an urgent need to raise awareness of prospective registration. PACTR provides useful data to map clinical trial conduct on the African continent.
Patient or healthcare consumer involvement:
None.
A clinical trials registry is a database in which key administrative and scientific information about planned, ongoing and completed trials is stored. The Pan African Clinical Trials Register (PACTR) aims to assist regional efforts towards transparency and harmonization of clinical trial research, by promoting prospective clinical trial registration and providing a venue to register and search the database of African clinical trials.
Objectives:
To describe and report on the first 1000 African controlled clinical trials registered in PACTR.
Methods:
This is a cross-sectional study. We extracted data for the first 1000 trials registered in PACTR to Excel. Data fields included intervention, condition, participant age, country, sample size, ethics, country of principal investigator, funders, number of sites. We conducted descriptive analysis using Stata software and generated frequency tables.
Results:
We found 757 (76%) single-center studies, for which the most common countries of registration were Egypt 430 (56.8%), followed by South Africa 75 (9.9%), and Kenya 45 (5.94%). Most of the trials (80%) were conducted in adults. Median sample size was 98 with an interquartile range of 52 to 240. Funding was most often from a University (37%), 14.4% were self funded, 13.9% government funded and 6.7% were funded by the European & Developing Countries Clinical Trials Partnership (EDCTP). A quarter of registered trials were in infectious and parasitic diseases, followed by pregnancy and childbirth (6%). Drug therapies were the intervention in 258 (26%) trials, 176 (18%) were prevention interventions, and 41 (4%) were diagnostic trials. Half of the trials (50%) were prospectively registered. Ethics approval was available for 893 trials (89%).
Conclusions:
Registration on PACTR continues to grow since 2009. The conditions investigated reflect the local burden of disease in infectious diseases and maternal-child health. University funding is commonly reported, indicating that PACTR is a platform for trial registration by local researchers. Given the high percentage of retrospectively registered trials, there is still an urgent need to raise awareness of prospective registration. PACTR provides useful data to map clinical trial conduct on the African continent.
Patient or healthcare consumer involvement:
None.