Initiation of the evaluation

4. Initiation of the evaluation 4.1 Initiation date of an evaluation

The evaluation formally starts on the initiation date.

When a topic is selected by the Medical Technologies Advisory Committee (MTAC) (see section 3), it is normally scheduled into the next available slot for a diagnostics evaluation. The start of the timeline for that slot is the initiation date. If there is a gap of more than a few weeks between the MTAC referral and the initiation date, the sponsor of the notified technology is informed of the initiation date in advance in confidence and is sent introductory

information about the Programme. The topic lead at NICE is appointed before the initiation date and is available for informal discussions with the sponsor before the initiation date. The External Assessment Group (EAG) is usually identified before the initiation date.

In exceptional circumstances a topic may not be scheduled for the first

available slot but be allocated a different initiation date. For instance a topic of particular urgency to the NHS could be prioritised for evaluation before other technologies already identified. This decision is taken by the Centre Director taking into account the views of the product sponsor.

Should the initiation date need to be postponed for any reason, the sponsor and the EAG are informed.

4.2 Activities undertaken when an evaluation is initiated

On the initiation date four separate strands of activity are started:

scoping begins (see section 5)

contact is made with product sponsors and comparator manufacturers (see section 4.2.1)

recruitment of specialist Committee members commences (see section 4.2.2)

registered stakeholders are identified (see section 4.2.3).

4.2.1 Contact with sponsors and comparator manufacturers during the evaluation

When a topic is selected by MTAC, a Diagnostics Assessment Programme analyst is assigned to it as the topic lead. On initiation of the evaluation the topic lead contacts the sponsor of the notified technology with the following:

general information about the Programme an invitation to participate in the evaluation

4 – Initiation of the evaluation

details of how information (including confidential information) will be handled during the course of the evaluation

the expected timetable of the evaluation

details of the stakeholder registration process and an invitation to register and a request to:

formally agree to participate in the evaluation

complete a confidentiality form and provide contact details

provide all relevant data of which the sponsor is aware (including confidential and unpublished data) to enable scoping to start declare that all relevant data have been provided.

If alternative technologies are identified as described in section 5.2.1, the sponsors of these technologies are contacted by the topic lead to inform them that their product is being considered for inclusion in the evaluation and they are invited to register as stakeholders. If their technology is included in the final scope they receive the information and requests outlined in the previous paragraph.

Sponsors of all the technologies listed in the final scope may be contacted during the assessment period by the topic lead on behalf of the EAG with a request for additional information to assist with the assessment.

Manufacturers of non-generic comparator technologies (see section 5.2.1) identified during scoping are contacted and invited to register as stakeholders.

They are not asked to provide data.

4.2.2 Recruitment of specialist Committee members

Specialist Committee members (described in section 1) are recruited at the beginning of the evaluation process and are appointed for the duration of a single evaluation (normally about 10 months). Both professional and lay specialist Committee members are appointed. These posts are advertised on NICE’s website

(www.nice.org.uk/getinvolved/joinnwc/join_a_nice_committee_or_working_gro up.jsp) for at least 5 weeks. A panel consisting of the Chair of the Committee, the Programme Director and the Associate Director selects the specialist Committee members and their appointment is reviewed and ratified by the Centre Director.

It is possible that the full range of specialist knowledge and expertise required by the Committee will only become apparent when the final scope has been agreed. Additional specialist Committee members may therefore be appointed if necessary once the scope has been finalised.

4 – Initiation of the evaluation

Specialist Committee members are full decision-making members of the Committee, and are also members of the assessment subgroup (see section 5.5). In addition they may support the EAG on behalf of the Committee during the assessment phase. However they are expected to maintain sufficient independence from the assessment in order to be able to contribute to the Committee’s discussions on the quality of the assessment and the

development of guidance recommendations from that assessment.

Specialist Committee members must meet the requirements of NICE’s code of practice for declaring and dealing with conflicts of interest

(www.nice.org.uk/aboutnice/whoweare/policiesandprocedures/policiesandpro cedures.jsp). They complete a declaration of interests form with their

application and must declare any interests at the beginning of each meeting.

Any applicant with an interest that would not permit them to take part in the Committee’s decision-making is unlikely to be appointed as a specialist Committee member.

4.2.3 Identification of registered stakeholders

At the beginning of the evaluation the topic lead and the project manager search various sources to identify potential registered stakeholders (described in section 1). Sources may include former and current clinical guideline

development groups, patient and carer organisations known to the Patient and Public Involvement Programme (PPIP) at NICE, product sponsors and other manufacturers, Royal Colleges and other professional organisations, and suggestions from the Diagnostics Advisory Committee and the Medical Technologies Advisory Committee. The individuals and organisations identified are contacted and invited to register. Additional potential

stakeholders may be identified during the scoping period; if so they too are contacted and invited to register.

Stakeholders may register at any time during the development of guidance.

There is more information here: Diagnostic technologies stakeholder registration.