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European Stroke Network Clinical Trial Platform

The ESN Clinical Trial Platform provides a clinical trial network of centers associated with preclinical sites to allow for swift transition into clinical phase I-II trials, and coordinate the ongoing clinical trial activities of the partners, such as data entry and management and data sharing. It is coordinated by the University of Heidelberg and the Karolinska Institute. The ESN Trials Platform also coordinates the design, fund raising, ethical and regulatory issues of a phase I-II studies emerging from the ESN research.

The ESN Trials Platform responds to several new opportunites for enhanced clinical stroke research in Europe. These include:

  • Increased opportunities of translating pre-clinical research to clinical practice/trials. There are several European driven pre-clinical research projects that soon could enter the clinical stage. The ESN Trials Platform offers opportunities for faster and more cost-effective translation of pre-clinical research to clinical experience regardless if initiated from academic institutions or from industry.
  • Increased opportunities to run investigator driven trials. The industry- independent European Trials Platform facilitates investigator driven trials. Examples include, but are not limited to: provision of cost effective monitoring procedures in line with GCP, procedures for submitting trial concepts, and clinical study protocols online, peer review systems, educational and certification modules adapted to GCP and individual trial settings, publication of study protocols on line and data ownership by investigators.
  • Increased demand to optimize conditions for collaboration with industry. The ESN Trials Platform is a strong partner to industry. By having such a Trials Platform, the scientific community takes a more active role for study protocol development and transparency, data management and publication. The industry does not have access to clinically well-characterized biobanks, and it is therefore the task of the academic community to investigate this material and provide novel targets for drug development.
  • Opportunity for enhanced knowledge sharing among stroke practitioners interested in participating in clinical trials. The ESN Trials platform plays an important role in promoting knowledge sharing on front-line stroke research and trial logistics, educational support and support in contacts with ethics committees.

The ESN Trials Platform is based on the SITS Network (Safe Implementation of Treatments for Stroke). The SITS Network is the world’s largest stroke treatment network with more than 500 participating stroke units in over 30 countries. Participating clinics are primarily located in Europe but also in Asia, the Middle East, Australia and South America. More than 2,000 researchers and MDs are currently active in this network. The objective of SITS is broad implementation and qualitSITSy development of evidence-based stroke treatments.

 

The specific objectives of the ESN Trials Platform are:

  • Adapt SITS (Safe Implementation of Treatment for Stroke) network and database to support EUROPEAN STROKE TRIAL PLATFORM.
  • Support pre-clinical trial design and pre-clinical data acquisition to facilitate the transition from pre-clinical results into clinical application.
  • Discuss the results of the preclinical testing of innovative therapies within the consortium and select the most promising candidate(s) for clinical trial.
  • Allow swift transition into clinical phase I-II trials.
  • Coordinate ongoing clinical trial activities of the partners.
  • Coordinate the design and fund raising of a phase I/II study emerging from the research.
  • Coordinate ethical and regulatory issues.

 

Trial Platform Leaders

Leaders of the trial platform are Prof. Nils Wahlgren from the Karolinksa Institute, Prof. Michael Hennerici and Prof. Werner Hacke from the University of Heidelberg. Prof. Wolfgang Eisert will also provide guidance with years of industrial experience in conducting large clinical trials.