PERMIT
PERsonalised Medicine TrialsFunding programme: Horizon 2020 (N874825)
Coordinator: ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (ECRIN),
Budget: €2M
Duration: 2 years (Jan 2020 - Dec 2021) - extended Jun 2022
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 addressed 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).
Training material
To better understand the PERMIT recommendations and facilitate their understanding and implementation, an interactive online training has been developed. This training is designed to address the needs of various stakeholders who contribute to personalised medicine research: researchers from public and private sectors, clinicians, policy makers, regulatory authorities at a national or regional level, students, ethics committee representatives, patient groups, patients and citizens.
The training is available at three different levels of specialization in the domain.
The “PERMIT Overview” series provides a brief overview of the personalised medicine research pipeline. It gives a quick explanation of the methodology that was followed to develop the recommendations, and presents each of the stages of the personalised medicine pipeline, their challenges and how the recommendations can help to strengthen the quality of the research.
The “In-depth” series dives into each of the stages of the personalised medicine research pipeline. For each of the stages the methodology that was followed to develop the recommendations is explained, followed by the gaps and challenges that were identified. The recommendations are then presented in detail and their potential impact is illustrated with examples and use cases. You can choose to delve in depth into one or all of the stages.
The “PERMIT in lay terms” series allows patients and citizens to get familiar with personalised medicine research, its different stages and with the PERMIT project’s recommendations. It presents the “why” behind the PERMIT project, the different stages of the research pipeline, and explains why the recommendations are important and how they can make a difference for patients and citizens.
Register here to follow any or all of the series at your own pace.
Information for patients
LEAFLET
What is the PERMIT project? Which PERMIT recommendations are most relevant for patients? Why are these important? All of these questions are addressed in this short leaflet, developed in collaboration with the European Patients' Forum (EPF).
LAY SUMMARY - TRANSLATIONAL METHODS
The translational stage is essential in the personalised medicine research pipeline. A review of the existing literature was conducted to map the methods that are currently used during this stage and to identify the main gaps and challenges that could be addressed with targeted recommendations.
Read more about the findings here.
LAY SUMMARY - CLINICAL TRIALS IN PERSONALISED MEDICINE
Evaluating therapeutic solutions through clinical trials is essential, before integrating them into routine care. A review of the literature on the methods and clinical trial designs used in personalised medicine was conducted to better understand the most commonly used designs and to identify gaps and challenges that could be addressed with targeted recommendations.
