EJP – Internal Call for proposal – Demonstration project on existing statistical methodologies to improve RD clinical trials

EJP – Internal Call for proposal – Demonstration project on existing statistical methodologies to improve RD clinical trials

In the framework of the European Joint Programme on Rare Diseases (EJP RD) the following call for proposal has been launched: “Demonstration projects on existing statistical methodologies to improve RD clinical trials”.

The call aims to show the usability and capability of the innovative statistical methodologies for clinical trials in rare diseases, which have not been demonstrated on existing data for specific rare disease clinical trials yet.

The demonstration projects should use one of the following nine innovative statistical methodologies

  • Uncertainty evaluation (bias assessment)
  • Primary outcome variable (surrogate)
  • Primary outcome variable (co-primary)
  • Use of external information (historical control)
  • Use of external information (extrapolation)
  • Use of external information (dose response profiles)
  • Use of external information (single arm trials – threshold crossing)
  • n-of-1 trials
  • Rigorous use of longitudinal information, linked to an existing clinical trials dataset for a specific rare disease.

Submission of demonstration projects is limited to partners from institutions beneficiaries of the EJP RD. This includes Linked Third Parties or, parties bound by the Network Agreement with the beneficiary institution (and thus being able to integrate EJP RD project as Linked Third Party at later stage).

Further details on the call are available at this link.

Submission deadline for the proposals is 15th of may 2020.

In January 2019, the European Joint Programme on Rare Disease (EJP RD) started its activities aimed to create a comprehensive, sustainable system allowing virtuous circle between research, care and medical innovation. TEDDY Network is among the beneficiaries of this new Co-fund action and provides its contribution in this programme intended to create a research and innovation pipeline “from bench to bedside”, ensuring a rapid translation of research results into clinical applications and uptake in healthcare for the benefit of the patients. All the TEDDY members are considered as third parties in the European Joint Programme on Rare Disease and are therefore eligible for funding under this Internal Call for proposal.

For more information about the project, please visit the EJP official website.

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