Article type
Year
Abstract
Background: Publicly accessible clinical trials registries are crucial for providing information about planned, ongoing, completed or even discontinued clinical trials for patients and their doctors, scientists, health professionals, funding organizations and the general public. National registries such as the German Clinical Trials Register (DRKS) are an indispensable tool to inform the public in the national language. Practitioners, patients and laymen clamour urgently for data available in national languages. These registries help to:
- conduct reviews, meta-analyses, and medical guidelines using a basis of comprehensive and complete trial information;
- avoid misinformation and to reduce bias in health care and health research;
- utilize resources reasonably so that clinical trials don’t have to be reiterated, exposing patients to an unnecessary risk.
To meet these needs requires comprehensive, complete, and consistent data in clinical trial registries. Publications regarding data quality in clinicaltrials.gov (1) and the World Health Organization (WHO) Meta-Portal (2) showed the data quality is insufficient.
Objectives: The trial data in DRKS will be examined analogously for completeness, accurateness and consistency. A lot of automatic and manual queries in DRKS should lead to a high data quality, that stands out from other databases.
Methods: Data on the following four topics will be extracted, coded and analyzed: intervention of the trial, endpoints, contact details, study design. For all publically accessible fields the filling degree will be calculated.
Results: Preliminary evaluations showed consistent and nearly complete information in all analyzed fields. Further analyses will be presented.
Conclusions: High data quality in trial registries is essential for clinical research and health care, DRKS endeavours to contribute to this scientific task.
Literature:
1. Zarin DA, Tse T, Williams R et al. The ClinicalTrials.gov results database-update and key issues. N Engl J Med 2011;364(9):S852–60.
2. Viergever RF, Ghersi D, Scherer RW. The quality of registration of clinical trials. PLOS ONE 2011;6(2):Se14701.
- conduct reviews, meta-analyses, and medical guidelines using a basis of comprehensive and complete trial information;
- avoid misinformation and to reduce bias in health care and health research;
- utilize resources reasonably so that clinical trials don’t have to be reiterated, exposing patients to an unnecessary risk.
To meet these needs requires comprehensive, complete, and consistent data in clinical trial registries. Publications regarding data quality in clinicaltrials.gov (1) and the World Health Organization (WHO) Meta-Portal (2) showed the data quality is insufficient.
Objectives: The trial data in DRKS will be examined analogously for completeness, accurateness and consistency. A lot of automatic and manual queries in DRKS should lead to a high data quality, that stands out from other databases.
Methods: Data on the following four topics will be extracted, coded and analyzed: intervention of the trial, endpoints, contact details, study design. For all publically accessible fields the filling degree will be calculated.
Results: Preliminary evaluations showed consistent and nearly complete information in all analyzed fields. Further analyses will be presented.
Conclusions: High data quality in trial registries is essential for clinical research and health care, DRKS endeavours to contribute to this scientific task.
Literature:
1. Zarin DA, Tse T, Williams R et al. The ClinicalTrials.gov results database-update and key issues. N Engl J Med 2011;364(9):S852–60.
2. Viergever RF, Ghersi D, Scherer RW. The quality of registration of clinical trials. PLOS ONE 2011;6(2):Se14701.