• Adam Manhi (chair)

• Emma Salib (programme manager)

• Jennifer McCaffery (lay)

• Kaeden Bunting (lay)

• Thomas Smith (patient)

• Trishna Bharadia (patient)

• Shira Peleg Hasson (clinical)

No conflicts declared by panel

Approved

• Broad agreement the proposal is well set out, with clear use cases and goals for accessing the real-world data.

• Good examples of target outputs (e.g. Lancet Journal of Oncology; ASCO conference).

• Activities following data access are clear and detailed, with explicit link between access and benefit, where specific unmet need and patient benefit is clear.

• The panel raised several comments on other aspects of the application including:
  
  

  • Expanding on detail of selected use cases i.e. Health Technology Assessment, Health Economics Outcomes Research and Market Access use case.

  • Capturing additional details in the lay summary (e.g. size of target population; mortality; current treatments available; impact of Gilead’s existing therapies).

  • Providing further detail on patient engagement, including Gilead’s current engagement activities and planned activity after data access granted.