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Abstract
Background: In an effort to improve the reporting of clinical trial results, several pharmaceutical companies and other entities have recently implemented clinical trials results databases.
Objectives: To identify existing web-based, publicly accessible clinical trial results databases and systematically evaluate their usefulness as a resource for conducting systematic reviews.
Methods: Databases were located through internet searches, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Clinical Trials Portal, and expert referrals. We extracted from each database the internet address, sponsor, sponsor's inclusion policies, methods of determining completeness, types of studies and products currently included. We also assessed whether trial summaries followed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline for the Structure and Content of Clinical Study Reports (ICH E3), and identified which elements were searchable.
Results: We identified 13 web-based results databases, eight of which are sponsored by the pharmaceutical industry. One of these (ClinicalStudyResults.org) contains records submitted by several different companies. All websites include information about policies for including trials, but policies for ensuring completeness are not explicit. At present, none had registered all eligible or required studies, and none includes a target date for completion. The search capability of industry-sponsored databases was limited. The number of records in these databases is growing; nevertheless, the drugs included represent only a small fraction of marketed drugs. Trial summaries in industry-sponsored databases follow ICH E3 guidelines; summaries in most other databases do not. Governmentsponsored databases have other advantages, however, such as user-friendly search engines and study design details of particular interest to systematic reviewers.
Conclusions: For existing clinical trials results databases to be a useful resource for systematic reviewers, further information needs to be made easily available. Strengths and weaknesses of different databases can be used as a guide for designing more useful clinical trials results databases.
Objectives: To identify existing web-based, publicly accessible clinical trial results databases and systematically evaluate their usefulness as a resource for conducting systematic reviews.
Methods: Databases were located through internet searches, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Clinical Trials Portal, and expert referrals. We extracted from each database the internet address, sponsor, sponsor's inclusion policies, methods of determining completeness, types of studies and products currently included. We also assessed whether trial summaries followed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline for the Structure and Content of Clinical Study Reports (ICH E3), and identified which elements were searchable.
Results: We identified 13 web-based results databases, eight of which are sponsored by the pharmaceutical industry. One of these (ClinicalStudyResults.org) contains records submitted by several different companies. All websites include information about policies for including trials, but policies for ensuring completeness are not explicit. At present, none had registered all eligible or required studies, and none includes a target date for completion. The search capability of industry-sponsored databases was limited. The number of records in these databases is growing; nevertheless, the drugs included represent only a small fraction of marketed drugs. Trial summaries in industry-sponsored databases follow ICH E3 guidelines; summaries in most other databases do not. Governmentsponsored databases have other advantages, however, such as user-friendly search engines and study design details of particular interest to systematic reviewers.
Conclusions: For existing clinical trials results databases to be a useful resource for systematic reviewers, further information needs to be made easily available. Strengths and weaknesses of different databases can be used as a guide for designing more useful clinical trials results databases.