Table 3.
Top three priorities per strategic areas of development.
Patient-centred drug development | n (%), N = 135 |
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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 |
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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 |
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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 |
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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%) |