On December 1 and 2, 2020 the PERMIT project held its Gap Analysis Workshop. This important milestone of the project corresponds to the final phase of the scoping review process that was carried out in the first year of the project, under the lead of the Mario Negri Institute for Pharmacological Research. Representatives from all consortium members participated in the workshop, as well as representatives of the EMA, EUnetHTA and the CTFG, who are associated partners of the PERMIT project.
During the workshop, the protocol that was applied for the scoping review was presented. This was followed by individual presentations by the work package (WP) leaders, who performed the individual reviews focusing on: stratification and validation cohorts (WP3), machine learning and stratification (WP4), preclinical methods for translational development (WP5) and clinical trial designs (WP6). Each presentation covered the individual scoping review process, the main findings in the literature on the current methodologies that are applied, and the major gaps identified at each stage of the personalised medicine review pipeline.
Through the presentations and discussions, the key questions that will be explored by each WP when drafting recommendations were identified. Among them, the following can be highlighted:
- Sample size calculation for stratification and validation cohorts
- Validation workflows for stratification
- Models for stratification and treatment selection
- Data quality and data management
- Regulatory requirements for algorithms and for generating omics data
The project will hold its third general assembly meeting in January 2021, where the work plans of each WP will be presented, for the second and final year of the project. Throughout the second year, a series of workshops will be organized within WPs 3 to 6, to discuss the identified questions in detail and to draft the specific recommendations. Consortium members, associated partners and external experts and stakeholders will be invited to participate in these workshops, to foster insight from all relevant stakeholders and generate recommendations that will correspond to their expectations.