Clinical trial registries

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. Here you can find the list of WHO clinical trial registries, with profiles and links for the respective registry.

Karolinska Institutet (KI) has approximately 100 clinical trials and over 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. From 31 January 2022, clinical trials involving investigational medical products will be registered in CTIS instead of EudraCT. Information about these three clinical trial registries is provided 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 CTIS

Clinical Trials Information System (CTIS) is a new common EU web portal and database for clinical trials conducted in the EU and countries that are part of the European Economic Area (EEA). CTIS is based on the new EU-common regulation, Regulation EU 536/2014, also called Clinical Trials Regulation (CTR), which entered into application on 31 January 2022. CTR coordinates the processes for assessment and supervision of clinical trials throughout the EU and has thus simplified the application process for the applicant and streamlined the review process for the national regulatory authorities. Only a single application for clinical trial is submitted to CTIS, after which the Medical Products Agency and the Ethical Review Authority get access to the application and can review and report decision to the applicant directly via CTIS. CTR also ensures that there are high standards of safety for all patients participating in the clinical trials.

The portal manages everything related to the clinical trial, from application to results reporting. The CTIS portal enables transparency and provides the public with access to information on clinical trials conducted in the EU/EEA through a searchable public database. The information the database provides includes information about trial design, participants, adverse events and trial results. CTIS 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.

Information about EudraCT

On 31 January 2022, the new EU-common regulation entered into application, Regulation EU 536/2014, also called Clinical Trials Regulation (CTR). This means that from 31 January 2022, new clinical trials should be registered in CTIS (Clinical Trials Information System), instead of 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.