1. Introduction to Diagnostics Assessment Programme
1.5 Participants in the Diagnostics Assessment Programme process
Table 1 Participants in the Diagnostics Assessment Programme process Diagnostics
Advisory Committee
The Diagnostics Advisory Committee (DAC or ‘the
Committee’) is an independent Committee consisting of 22 standing members and additional specialist members.
The role of the Committee is:
to consider evidence
to make draft recommendations
to consider public consultation comments
to make final recommendations for publication in NICE guidance.
Standing Committee members have a range of expertise, and include clinicians who develop and use diagnostic technologies, people who can provide a lay perspective on the issues affecting patients and the NHS, experts in regulation and evaluation of healthcare technologies, people with commissioning experience in the NHS, and people with experience of the diagnostic technologies industry. Standing Committee members are recruited through an open advertisement posted on the NICE
website. They are appointed for a period of up to 3 years by a panel including an Executive or Centre Director, a Non-Executive Director and the Chair of the Committee.
Specialist Committee members are recruited for their expertise in the diagnostic technology under consideration and/or the care of patients in the pathway in which the results of the test are used. They are recruited for each topic; their term of office is for the duration of the topic (approximately 10 months) and their involvement is for that topic only. Numbers may vary from topic to topic. They typically include clinicians or researchers using the
diagnostic technology or involved in the care pathway, as well as lay persons with a perspective on the condition being diagnosed. Specialist Committee members have the same decision-making status as standing members of the
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Committee. See section 4.2.2 for details on how specialist Committee members are appointed.
NICE is committed to the values of equality and diversity and welcomes applications for membership of the
Committee from all sectors of the community.
Registered stakeholders
Registered stakeholders:
are invited to attend the scoping workshop
receive the diagnostics assessment report (DAR – see section 6.3) for comment (these comments are considered by the Committee when it formulates its draft recommendations on a topic)
have the same input to the development of diagnostics guidance as members of the public (see below).
Identifying potential registered stakeholders is an important part of the process. Registration is open to anyone with an interest in the topic who is (or belongs to) one of the
following:
a manufacturer, developer, distributor or agent of a relevant technology (see below)
a trade association representing manufacturers, developers, distributors or agents of diagnostic technologies
a national organisation representing healthcare professionals
a national group representing patients and/or carers a provider of NHS services in England
a commissioner of NHS services in England a statutory organisation such as the Department of
Health
a research organisation.
Stakeholders register via NICE’s website. Potential stakeholders may register at any point in the evaluation process. More information about registering is available from: Diagnostic technologies stakeholder registration Product
sponsors
Manufacturers, developers, distributors or agents of:
a technology selected for assessment via DAP by the Medical Technologies Advisory Committee (MTAC) (see section 3) or
a technology identified during the scoping period as a
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possible related alternative technology (see section 5.2.1) to the technology selected by MTAC
are referred to in this process as product sponsors, and are invited to join the evaluation.
Product sponsors:
are invited to register as stakeholders
are asked to provide data to support the evaluation of the technology or technologies, as outlined in section 4.2 are invited to attend the Committee meetings to
comment on matters of factual accuracy, and to respond to questions from the Committee about information submitted to inform the evaluation, including confidential information (see section 7 about Committee meetings).
When a topic is selected for the Diagnostics Assessment Programme, NICE informs the product sponsor of its intention to evaluate that technology.
Manufacturers,
Manufacturers, developers, distributors or agents of any technology identified during the scoping period as a comparator (see section 5.2.1) are able to register as a stakeholder (see above). Comparator technologies are those that are most commonly used or are recommended in current NICE guidance for the indications and uses that feature in the evaluation.
External Assessment Group (EAG)
The External Assessment Group (EAG) is an
independent academic group that prepares a review of the clinical effectiveness and cost effectiveness of the technology or technologies under consideration. The DAR prepared by the EAG is based on a systematic review of the clinical and health economic literature (including data supplied by the product sponsor or sponsors when
appropriate) and appropriate models. The EAG is commissioned to carry out this assessment on NICE’s behalf by the National Institute for Health Research (NIHR) - Evaluation, Trials and Studies Coordinating Centre
(NETSCC).
The EAG is invited to the scoping workshop (see section 5.4), the assessment subgroup meeting(s) (see section 5.5) and Committee meetings. The EAG may also work with the NICE Diagnostics Assessment Programme team during the
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early stages of scope development.
Members of the public
Members of the public may:
comment on the diagnostics consultation document (DCD) (see section 7 for more information)
apply to attend Committee meetings (see section 7 for more information)
apply to become a lay specialist Committee member (see section 4.2 for more information).
NICE staff
Diagnostics Assessment Programme team
The Diagnostics Assessment Programme (DAP) is part of NICE’s Centre for Health Technology Evaluation (CHTE).
The DAP team consists of the Associate Director and technical, project and administrative staff who support the DAC in developing diagnostics guidance. Members of the DAP team:
develop a detailed draft scope, including carrying out research on the care pathway
liaise with EAGs about evidence assessments prepare evidence overviews for the Committee arrange public consultation on the Committee's draft
recommendations
prepare guidance for publication
ensure agreed timelines and quality assurance standards are followed
promote awareness of the Programme.
Patient and Public Involvement Programme (PPIP)
The Patient and Public Involvement Programme (PPIP) recruits and supports lay members of the Committee (both standing members and specialist members), identifies
appropriate patient and carer organisations to be invited to register as stakeholders, encourages members of the public and patient organisations to respond to consultations, and establishes links with patient organisations with an interest in diagnostics guidance. NICE uses the terms ‘patient
organisation’ and ‘patient group’ when referring to patients, carers, and community and other lay organisations and charities, including those representing people from groups protected by equalities legislation.
Information Services
The Information Services team searches for information and evidence from conventional sources and ‘grey’ literature.
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This information is primarily used by the DAP team to prepare the scopes.
Editorial The editors review the DCD and the diagnostics guidance document (DGD). NICE editors prepare the final guidance for publication on the NICE website and also develop a lay explanation of the recommendations when appropriate.
Implementation NICE provides advice and tools to support the local implementation of its guidance. In general NICE’s implementation team:
ensures intelligent dissemination to the appropriate target audiences
actively engages with the NHS, local government and the wider community
works nationally to encourage a supportive environment provides tools to support putting NICE guidance into
practice
demonstrates significant cost impacts – either costs or savings at local and national levels
evaluates uptake of NICE guidance shares learning
develops educational material to raise awareness of NICE guidance and encourages people to input into its
development.
There is an implementation support plan for each piece of guidance. The implementation team produces
implementation support tools (such as costing tools and audit tools) to help the NHS implement NICE guidance.
These tools are developed with advice from Committee members and reference groups as appropriate.