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. 2021 Feb 16;55(4):646–655. doi: 10.1007/s43441-021-00263-2

Table 3.

Top three priorities per strategic areas of development.

Patient-centred drug development n (%), N = 135
Ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation 104 (77%)
Enhance understanding and appropriate use of methods to capture information on patient preferences and the potential acceptability of trade-offs between treatment benefit and risk outcomes 84 (62%)
Reinforce patient relevance in evidence generation, increased patient involvement in regulatory activities, including patient representatives as additional experts in Scientific Advisory Groups, as well as patient contribution to scientific advice and protocol assistance 81 (60%)
Enhancing innovation n (%), N = 131
Explore innovative ways of using real-world data to assess clinical effectiveness in routine clinical settings 86 (66%)
Explore developing standards for new areas, e.g. digital health, artificial intelligence, including machine learning 84 (64%)
Explore developing more agile regulatory approvals processes for novel and generic products 79 (60%)
Proactive and robust surveillance n (%), N = 125
Optimise signal and risk assessment functions to respond to risks in real time 75 (60%)
Enhance information sharing 70 (56%)
Develop systems and processes for integrated medicines and devices surveillance 68 (54%)
Organisational excellence/efficiency n (%), N = 124
Explore opportunities to develop collaborations and information sharing with key global regulators, international partnerships with WHO (World Health Organisation) and other key players 92 (74%)
Invest in scientific capabilities to meet emerging needs. Invest in staff’s specialist skill sets, and in facilities to deliver state of the art regulation and services 87 (70%)
Identify future capability needs and ensure the right skill mix is available to support innovation and deliver priority programmes and core functions 83 (67%)