Article type
Year
Abstract
Background: As the number of paediatric clinical trials increases it is essential that their existence is publicly documented and that eventually their results will be made publicly available. Registering clinical trials can bring us one step closer to an unbiased and efficient clinical world.
Objectives: To determine a) the accessibility of ongoing paediatric trial data, b) how many retrospective clinical trial registers include paediatric drug trials, and c) the ease of searching for ongoing paediatric trials.
Methods: We asked paediatricians and Medical-Ethical Review Boards of all eight paediatric University Medical Centres in the Netherlands to provide a list of all known paediatric drug trials, which were planned or ongoing between September 2005 and December 2008. Simultaneously, we identified Dutch paediatric drug trials through the (inter)national prospective trial registers using the WHO Search Portal of the International Clinical Trial Registry Platform (ICTRP).
Results: The field identified 172 paediatric drug trials, of which 97 (56%) had been registered prospectively. A total of 299 Dutch paediatric drug trials were found searching the WHO Search Portal. Most of these (70%) were registered in ClinicalTrials.gov, 25% in the Netherlands Trial Register (NTR), and 5% in ISRCTN.org. The WHO Search Portal facilitated searching for paediatric trials, resulting in a very low number needed to screen (1.2). However, not all trials (17%) registered in the NTR were found by using the WHO Search Portal.
Conclusions: There are disparities between the number of ongoing trials, the completeness of registration and the sensitivity of the current search tools. It seems that ongoing paediatric drug trials are still not in the public domain because investigators and industry declare that they don’t want the information to be publicly available. Searching the WHO Portal for paediatric trials is easy, although there is reason to believe that not all registered trials can be found.
Objectives: To determine a) the accessibility of ongoing paediatric trial data, b) how many retrospective clinical trial registers include paediatric drug trials, and c) the ease of searching for ongoing paediatric trials.
Methods: We asked paediatricians and Medical-Ethical Review Boards of all eight paediatric University Medical Centres in the Netherlands to provide a list of all known paediatric drug trials, which were planned or ongoing between September 2005 and December 2008. Simultaneously, we identified Dutch paediatric drug trials through the (inter)national prospective trial registers using the WHO Search Portal of the International Clinical Trial Registry Platform (ICTRP).
Results: The field identified 172 paediatric drug trials, of which 97 (56%) had been registered prospectively. A total of 299 Dutch paediatric drug trials were found searching the WHO Search Portal. Most of these (70%) were registered in ClinicalTrials.gov, 25% in the Netherlands Trial Register (NTR), and 5% in ISRCTN.org. The WHO Search Portal facilitated searching for paediatric trials, resulting in a very low number needed to screen (1.2). However, not all trials (17%) registered in the NTR were found by using the WHO Search Portal.
Conclusions: There are disparities between the number of ongoing trials, the completeness of registration and the sensitivity of the current search tools. It seems that ongoing paediatric drug trials are still not in the public domain because investigators and industry declare that they don’t want the information to be publicly available. Searching the WHO Portal for paediatric trials is easy, although there is reason to believe that not all registered trials can be found.