Article type
Year
Abstract
Background: The German Association of Urology (DGU) initiated a project in 2010 to easily register clinical trials within the German Clinical Trials Register (DRKS), named DGU sub-register. The DRKS is a primary register of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Urology-related studies were retrospectively included in the DGU sub-register. However, the completeness of urologic trial registration in the DGU register remains unclear.
Objectives: To assess whether prostate cancer studies conducted in Germany were registered in the DGU sub-register.
Methods: The WHO ICTRP database was searched for all prostate cancer trials conducted in Germany (keyword: ‘prostate cancer’, limitation: ‘recruitment location’). The retrieved registration identifiers were used as search terms to identify the associated trials registered in the DGU sub-register. The increase in newly registered trials per year was analyzed using linear regression. Results are presented with 95% confidence intervals. A P value less than 0.05 was considered statistically significant.
Results: The search in WHO ICTRP identified 872 records for 194 trials. The annual number of registered trials identified in WHO ICTRP did not increase significantly (P value 0.063). Of all the identified trials, 108 (56%) also had a DGU-DRKS identifier and 25 (13%) were primarily registered in the DGU sub-register. While 67% of the trials were registered in 2010 to 2015, 33% were registered in 2009 or earlier. The annual increase was statistically significant (0.89 more registered trials/year; 95% CI 0.18 to 1.59: P value 0.018).
Conclusions: Only half of the prostate cancer studies are displayed in the DGU sub-register. Since the establishment of the DGU sub-register, trial registration increased annually. Whether this development is due to the availability of a user-friendly registration platform or to an increased awareness of trial registration cannot be determined. Furthermore, determining the true proportion of registered studies remains a challenge. Results may be biased by the completeness and quality of entries in the WHO ICTRP.
Objectives: To assess whether prostate cancer studies conducted in Germany were registered in the DGU sub-register.
Methods: The WHO ICTRP database was searched for all prostate cancer trials conducted in Germany (keyword: ‘prostate cancer’, limitation: ‘recruitment location’). The retrieved registration identifiers were used as search terms to identify the associated trials registered in the DGU sub-register. The increase in newly registered trials per year was analyzed using linear regression. Results are presented with 95% confidence intervals. A P value less than 0.05 was considered statistically significant.
Results: The search in WHO ICTRP identified 872 records for 194 trials. The annual number of registered trials identified in WHO ICTRP did not increase significantly (P value 0.063). Of all the identified trials, 108 (56%) also had a DGU-DRKS identifier and 25 (13%) were primarily registered in the DGU sub-register. While 67% of the trials were registered in 2010 to 2015, 33% were registered in 2009 or earlier. The annual increase was statistically significant (0.89 more registered trials/year; 95% CI 0.18 to 1.59: P value 0.018).
Conclusions: Only half of the prostate cancer studies are displayed in the DGU sub-register. Since the establishment of the DGU sub-register, trial registration increased annually. Whether this development is due to the availability of a user-friendly registration platform or to an increased awareness of trial registration cannot be determined. Furthermore, determining the true proportion of registered studies remains a challenge. Results may be biased by the completeness and quality of entries in the WHO ICTRP.