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. 2020 Sep 23;7:508. doi: 10.3389/fmed.2020.00508

Table 2.

Aggregate ranking of Core Recommendations (question 5, Human).

Number Core Recommendations Totala
9 Foster innovation in clinical trials 35
18 Promote use of high-quality real-world data (RWD) in decision making 30
17 Reinforce patient relevance in evidence generation 26
15 Contribute to HTAs' preparedness and downstream decision making for innovative medicines 25
1 Support developments in precision medicine, biomarkers, and “omics” 23
11 Expand benefit-risk assessment and communication 22
2 Support translation of Advanced Therapy Medicinal Products cell, genes, and tissue-based products into patient treatments 17
5 Create an integrated evaluation pathway for the assessment of medical devices, in vitro diagnostics, and borderline products 16
7 Diversify and integrate the provision of regulatory advice along the development continuum 16
29 Leverage collaborations between academia and network scientists to address rapidly emerging regulatory science research questions 16
13 Optimize capabilities in modeling and simulation and extrapolation 15
16 Bridge from evaluation to access through collaboration with Payers 13
10 Develop the regulatory framework for emerging digital clinical data generation 13
31 Disseminate and share knowledge, expertise, and innovation across the regulatory network and to its stakeholders 12
4 Facilitate the implementation of novel manufacturing technologies 12
28 Develop network-led partnerships with academia to undertake fundamental research in strategic areas of regulatory science 11
12 Invest in special population initiatives 10
25 Promote global cooperation to anticipate and address supply challenges 10
19 Develop network competence and specialist collaborations to engage with big data 10
14 Exploit digital technology and artificial intelligence in decision making 10
3 Promote and invest in the Priority Medicines scheme (PRIME) 9
6 Develop understanding of and regulatory response to nanotechnology and new materials' utilization in pharmaceuticals 6
24 Continue to support development of new antimicrobials and their alternatives 6
30 Identify and enable access to the best expertise across Europe and internationally 5
8 Leverage novel non-clinical models and 3Rs 5
22 Further develop external communications to promote trust and confidence in the EU regulatory system 4
26 Support innovative approaches to the development and post-authorization monitoring of vaccines 4
20 Deliver real-time electronic Product Information (ePI) 3
21 Promote the availability and uptake of biosimilars in health care systems 2
27 Support the development and implementation of a repurposing framework 0
23 Implement EMA's health threats plan, ring-fence resources and refine preparedness approaches 0
a

Total times chosen as first, second, or third most important.