Background:

Access to information and transparency regarding ongoing, completed and published clinical research is essential for appropriate decision making. The World Health Organization (WHO) Clinical Trials Search Portal (CTSP) enables users to search a central database that contains the trial registration data set provided by primary registers. Despite access to trial registries, there are limited resources to guide users to information regarding paediatric clinical trials. Children are an exceptional population with specific ethical and clinical concerns. In concordance with the UN millennium development goal of reducing child mortality, an increased need for transparency and information regarding ethics, regulations and experimental trials in children is required. A comprehensive vehicle to enable the identification of proposed and ongoing clinical trials in children will facilitate this priority.

Objectives:

1) To identify the specific requirements of a search portal to information about clinical trials in children; 2) to create a sensitive yet specific filter for use in the existing WHO International Clinical Trials Registry Platform search portal to identify clinical trials in children; 3) to create a resourceful website tailored to individual user profiles including clinicians, researchers, industry, regulators and the general public/parents.

Methods:

International experts involved with clinical trials registries and paediatric specialties were invited to collaborate. A filter to facilitate the identification of clinical trials in children was built using suitable paediatric lexicon and
associated synonyms in the Unified Medical Language System (UMLS) metathesaurus, and then applied to the CTSP. Website content was developed using input from all collaborators and test profile users.

Results:

It was determined that the website should facilitate access to specific information in a user-based format, including information regarding regulations, ethics and clinical trials. The filter appears to successfully identify clinical trials in children on the CTSP. The accuracy of the filter will be evaluated and the results reported at the meeting.

Conclusions:

Developing an informative website and a comprehensive filter to enable easy identification of ongoing clinical trials in children on a centralized search portal is an important development in improving transparency and promoting the conduct of ethical and relevant clinical trials in children.