PERMIT (PERsonalised MedicIne Trials)

The PERsonalised MedicIne Trials (‘PERMIT’) project on methodological standards for personalised medicine research will establish recommendations ensuring the robustness of personalised medicine trials. 

Activities

In a series of workshops, participants, partners and selected experts will address the various aspects of methodology, design, data management, analysis and interpretation in personalised medicine research programmes, with the objective of reaching consensus and publishing recommendations.

In particular, the project will undertake a mapping of the literature on methodological practices in the various steps of personalised medicine programmes, and identify needs in terms of standardised methodology. It will also address the design of stratification and validation cohorts, and examine the use of stratification algorithms and robustness of stratification methods. It will also provide recommendations on innovative trial designs for personalised medicine, and will assess personalised vs. non-personalised medicine approaches in clinical trials. 

Consortium and partners

The PERMIT consortium is composed of the following participants: pan-European research infrastructures (ECRIN, EATRIS, ELIXIR-LU/UNILU), funders (DLR), HTAs (KCE, ISCIII), patients (EPF), regulatory (ISS), data protection (TMF) and scientific experts.

Partners represent stakeholders interested in the quality of evidence generated by personalised medicine research (industry, medicine agencies, ethics committees, funders, journal editors, HTAs, BBMRI).

Funding

PERMIT has received funding from Horizon 2020 under grant agreement number 874825.