Tools and resources

Appendix J: Call for evidence

A call for evidence specifies the type of evidence being sought and, if appropriate, the review question being addressed. A call for evidence can be made at any point during the development of a guideline, but usually happens in the earlier stages. The time allocated for submission of evidence depends on the type of evidence and level of detail needed. A typical call lasts for 2 to 4 weeks, but it may be longer.

If it is likely that regulatory authorities hold relevant data, the appropriate regulatory authority may be approached to release those data as part of the call for evidence.

To simplify copyright considerations, only references or links should be submitted, or details of contacts for unpublished research. The developer will then obtain full copies of all relevant papers or reports, paying a copyright fee if necessary. Copies of full papers, in electronic or hard copy form, should not be submitted in response to a call for evidence.

Submissions of evidence should contain sufficient detail of the methods used to conduct the study to enable NICE to conduct quality assessment.

NICE will not consider the following material as part of a call for evidence:

  • promotional material

  • unsubstantiated or non‑evidence‑based assertions of effectiveness

  • opinion pieces or editorial reviews

  • potentially unlawful or other inappropriate information.

Registered stakeholders, relevant organisations or individuals approached are only able to submit evidence during a call for evidence, or during consultation on the draft guideline. Evidence submitted at other stages of guideline development is not considered, and the sender is informed.

Confidential information

Information or data that may be considered confidential include data that may influence share price values ('commercial in confidence') and data that are deemed intellectual property ('academic in confidence', that is, awaiting publication).

Confidential information should be kept to an absolute minimum. For example, information submitted should be limited to the relevant part of a sentence, a particular result from a table or a section of code. NICE does not allow a whole study to be designated confidential. As a minimum, a structured abstract of the study or economic model must be made available for public disclosure during consultation on the guideline. Results derived from calculations using confidential data are not considered confidential unless back‑calculation to the original confidential data is possible.

When the developer sends out a call for evidence, respondents are asked to complete a checklist that identifies the location of all confidential information contained in their submission, and for how long the information is likely to remain confidential. In addition to completing the checklist, respondents should indicate the part of their submission that contains the confidential information. All confidential information should be underlined. Information that is submitted under 'commercial in confidence' should also be highlighted in turquoise; information submitted under 'academic in confidence' should be highlighted in yellow. The underlining and highlighting should be maintained so that the committee knows which parts are confidential.

When documents are prepared for consultation and publication, NICE and the developer work with the data owners to agree a compromise between confidentiality and transparency, and strive to release as much information as possible. Any information that is still confidential is removed by the developer, and a note added to explain what has been done. NICE needs to be able to justify the recommendations in its guidelines on the basis of the evidence considered by the committee.

Documenting evidence received in response to a call for evidence

Information received from registered stakeholders, relevant organisations or individuals in response to a call for evidence should be recorded systematically and the details cross‑checked against evidence identified through other searching (for example, to check if it has already been assessed). Information should be assessed in the same way as published studies identified through the searches (see chapter 6).

Disclosing links with the tobacco industry

When submitting evidence in response to a call for evidence, stakeholders are asked to disclose whether their organisation has any direct or indirect links to, or receives or has ever received funding from, the tobacco industry. Disclosures will be included with the evidence presented to the committee.

Box 5.1 Examples of relevant evidence not routinely identified by searches

Ongoing research when an intervention or service is relatively new

Interim study results (not yet published) for longer-term studies

Studies that have been published only as abstracts

Health needs assessments

Protocols

Local pilot studies

Business cases

Financial reports.

Analyses of primary data

Data from patient registries and healthcare databases

Studies of the experiences of people using services, their family members or carers, or practitioners

Data about the off‑label use of medicines

Data on harms

Audit data

Implementation case studies

Economic models


This page was last updated: 31 October 2018