Process and methods

3 Who is involved?

3.1 NICE teams

The development team is made up of pharmacists and technical, project and administrative staff who are responsible for:

  • developing and reviewing processes and methods for evidence summaries

  • scoping and developing evidence summaries in line with the agreed process and standards (this includes selecting, critically appraising and summarising the evidence)

  • identifying and liaising with external topic experts, key stakeholders and companies, when applicable

  • quality assuring the content of evidence summaries

  • ensuring timelines and processes for quality assurance are followed.

This team liaises with other NICE teams to:

  • carry out literature searches

  • check for overlaps with other NICE work

  • estimate the resource impact of the medicine(s), including producing resource impact tools, when applicable

  • provide additional clinical input when applicable

  • identify potential implementation issues.

3.2 External topic experts

External topic experts are identified early in the development process from existing NICE networks, national professional organisations, NICE medicines and prescribing associates or the organisation commissioning the topic. They have significant expertise in the therapeutic area in which the medicine is to be used. Their role includes:

  • advising on the scope of the topic, including the population, intervention, comparator and outcomes (PICO)

  • clarifying any issues about the evidence base

  • advising on the clinical and practical implications of the information in the evidence summary, including likely place in therapy

  • reviewing the draft evidence summary documents independently and providing comments.

3.3 Stakeholder organisations

Stakeholders such as NHS England, Public Health England and the Medicines and Healthcare products Regulatory Agency (MHRA) may be asked to review the draft evidence summary documents within an agreed time frame before publication. The MHRA will be asked to comment if specific regulatory or safety issues arise.

Stakeholders are identified from existing NICE networks, national professional organisations, NICE medicines and prescribing associates or the organisation commissioning the topic.

3.4 Companies

If a topic includes a single proprietary medicine (including an off-label use), NICE tells the company that manufactures it about the evidence summary development, including the expected time frame. NICE invites the company to provide information to support the development of the evidence summary and respond to any questions NICE may have on this information. The company is also invited to comment on the factual accuracy of the draft evidence summary documents within an agreed time frame.

If a topic includes a non-proprietary medicine with multiple manufacturers, or the topic underpins an NHS England commissioning policy, companies are not contacted.