Clinical trial registries

The World Health Organization (WHO) International Clinical Trial Registry Platform (ICTRP) includes clinical registries that are approved for clinical trial registration. At Karolinska Institutet (KI), clinical trials are registered in EudraCT and clinical studies are registered in ClinicalTrials.gov.

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Introduction

The International Committee of Medical Journal Editors (ICMJE) requires clinical trials and clinical studies to be registered in a public clinical trial registry as a condition of publication. Regulatory authorities around the world have also begun requiring registration and submission of summary results to a publicly accessible clinical trial registry.  Research funding agencies have followed a similar course of action, as most funding agencies are now requiring clinical trials and clinical studies to be registered and results reported in an approved clinical trial registry. The ICMJE accepts publicly accessible registration in any registry that is a primary register of the "World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP)" that includes the minimum acceptable 24-item trial registration dataset or in ClinicalTrials.gov, which is a data provider to the WHO ICTRP. The list of WHO clinical trial registries, with profiles and links for the respective registry, can be accessed by downloading the "International Clinical Trials Registry Platform" document using the link below.

Karolinska Institutet (KI) has approximately 100 clinical trials and nearly 800 clinical studies that are currently registered. More than 95 percent of both clinical trials and clinical studies are registered in either EudraCT or ClinicalTrials.gov. Information about these two clinical trial registries is illustrated below.

Information about ClinicalTrials.gov

ClinicalTrials.gov is a web-based database and resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical trials and clinical studies on a wide range of diseases and conditions. The ClinicalTrials.gov database contains summary information on the study protocol, participants, study outcomes, and adverse events to facilitate transparency in the efficacy and effectiveness of research results. Clinical trials (Phases II-IV) and clinical studies are permitted to be registered in ClinicalTrials.gov, which are categorized as either interventional or observational. Information regarding the distinction between interventional and observational studies can be found on the “Clinical trials and clinical studies that require registration” webpage.

Information about EudraCT

The European Union Drug Regulating Authorities Clinical Trials (EudraCT) is a web-based database developed by European regulatory authorities for the European Union to provide each of them with an overview of clinical trials being conducted throughout the region. EudraCT helps facilitate information and communication of clinical trials between European authorities. EudraCT also provides European authorities with a better oversight of clinical trials and investigational medicinal product development, as well as enhancing protection of clinical trial subjects and patients receiving investigational medicinal products. The EudraCT database comprises vital information on the trial protocol, participants, study outcomes, and adverse events allowing for transparency of the efficacy and effectiveness of investigational medicinal products. It provides researchers and the public with information on clinical trials and PIP (Pediatric Investigation Plan) trials, which have been authorized in the EEA. It gives users the ability to search for information on Phase II-IV adult clinical trials and pediatric clinical trials recorded in the database. EudraCT permits registration of only clinical trials involving investigational medical products (IMP). Information regarding regulations and requirements for clinical trials can be found on both “Regulation and Requirements” and “Clinical trials and clinical studies that require registration” webpages.

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