Medical technologies evaluation programme methods guide

6.2.1 Search for published evidence

The scope informs the literature search for evidence. The sponsor carries out a literature search as part of its submission, and the external assessment centre validates this search to support its critical appraisal of the evidence in the assessment report.

The search typically covers relevant efficacy, effectiveness, usability and safety outcomes (including intermediate clinical outcomes) and available clinical and health economics studies of any type, including non-UK studies. A range of medical literature databases is systematically searched, including: primary research databases; registers or databases of systematic reviews; meta-analyses and technology assessment evaluations; registers or databases of ongoing clinical trials (including experimental or observational studies); and conference proceedings. The external assessment centre reproduces the sponsor's search to validate that all relevant evidence has been identified.

6.3.1 Purpose and rationale

To ensure that all available relevant evidence is taken into account, the committee considers unpublished research if it is within the scope of the evaluation. As with publicly available evidence, such as that in peer-reviewed journals, unpublished evidence may relate to primary clinical or secondary research. Unpublished evidence may be included in the sponsor's submission or identified by the external assessment centre. Unpublished data may be used to support a narrative review of the evidence, as well as to inform the design and conduct of new secondary research studies (section 7).

6.3.2 Unpublished evidence sources

There are 2 main sources of unpublished evidence:

6.3.3 Unpublished evidence submitted in confidence

Unpublished evidence is not normally considered confidential and may therefore be disclosed in publicly available guidance documents. However, it may occasionally be necessary for the committee to review data provided to the programme in confidence. The committee considers such evidence in a private part of the meeting.

Unpublished evidence is accepted under agreement of confidentiality and is not made available to the public. Such evidence includes commercial-in-confidence information (confidential because its public disclosure may affect the commercial interests of a particular company) and academic-in-confidence data (confidential because the full data are yet to be published).

If the owner of any unpublished data included in the submission believes that the data should be treated as commercial- or academic-in-confidence, they should clearly state the rationale, taking into account the following principles:

NICE asks data owners to reconsider restrictions on release of data either when the reason for the restrictions is not clearly explained, or when such restrictions would make it difficult or impossible for NICE to show the evidential basis for its guidance.