January 2020 DigiTrials board meeting minutes

3 key actions were discussed.

Action relating to the DigiTrials logo – There are 2 options available relating to logos which will be made available to the Board members to collectively agree and select. Board members were asked to take into consideration the NHS Lozenge which has previously been highlighted and discussed.

Action: Comms Lead to send an email to Board members containing the logos available to choose from.

Action relating to the website – Board members were advised that the website has been updated except for the DigiTrials logo which will be updated in due course.

Action relating to Milestone 3 – to be discussed and picked up later in the meeting under agenda item 3e.

The NHS DigiTrials Terms of Reference (ToR) version 1.4 to be updated to include new member names.

Additional wording covering conflicts of interest was shared with Board members and the requirement for members to register any interests with the Board Secretariat within 2 weeks was highlighted. This was agreed by the Board. The Board Secretariat to maintain a list of member interests.

Action: The Deputy Hub Director to provide suggested process for managing conflict of interest list to the Board Secretariat prior to sending the request.

Action: Board Secretariat to update the ToR document and send email with a suitable form/questionnaire requesting members to register their interests.

The Board agreed that the ToR was deemed to have been signed off once the amendments above have been made.

The HDR Q1 Report is due on 11th February 2020. Board members were advised that HDR were providing further guidance on how to complete the report.

Action: The Clinical Trials Service Delivery Lead to send the Programme Executive Members the HDR Q1 Draft report for sign off once the HDR clarification has been received.

The Board members were advised that a programme plan is in place which can be discussed in more detail outside the meeting as required. Executive Members are updated on a weekly basis of progress and a risks log is maintained.

It was highlighted that an outstanding programme management task is one relating to the KPIs and metrics for the programme.

A draft delivery hypothesis was discussed. This received positive comments from the members emphasising that it was helpful with delivery discussions taking place outside the Board. It was stressed that the programme will deliver the Minimum Viable Product (MVP) by end of March 2020 in parallel with additional user research in order to deliver an initial outcome that can be built upon after March 2020.

The Consortium Agreement has not yet been signed off. Once signed, the workstreams leaders will be asked to confirm alignment of workstream outcomes to the resources mentioned in the Consortium Agreement.

Work is being carried out to ensure the correct resources and skills are available for the data management elements of the programme.

A brief outline was given to members about the ongoing User Research. Suggestions from this were highlighted to the members and it was agreed that these should be addressed once the MVP had been delivered.

Action: The Hub Director/Clinical Trials Service Delivery Lead/ NIHR Representatives to work together to discuss the need to link with patient groups.

Action: The Deputy Hub Director to work with the Clinical Trials Service Delivery Lead to work out what capabilities are needed within the organisation.

Discussions took place about the need for the Hub to support trials across England. For example, the upcoming Orion 17 trial intends to involve patients from across England including areas which would have historically not have been included in trials.

The point was reinforced that that the current remit of NHS DigiTrials is restricted to the provision of a feasibility service and that this must be the focus of this Board and programme.

The programme roadmap was outlined, and the proposed timelines highlighted. Members were asked to send any comments about the timelines back to the Clinical Trials Service Delivery Lead due to the time constraints in the meeting.

Members were advised that the PPIE plan focuses on the feasibility service that the hub is developing. The first objective of the PPIE plan was to develop a plan; this was delivered to HDR UK at the end of Dec 2019.

The main purpose of the PPIE workstream is to explore issues relating to the use of the feasibility service to support trials conducted by a wide range of organisations (e.g. commercial, academic) and supported by diverse funders (e.g. government, charity, commercial) and the charging model required to ensure that the hub’s activities are sustainable. The PPIE workstream will work with Comms and HDR UK. This will be tested further when additional patient representatives are involved.

A question was raised about how we make this real for patients and manage expectations? We need to ensure that we are transparent about the trials and share a message about the purpose of trials – to support the development of new or better drugs and thereby improve patient care and population health.

We need to ensure the public and patients understand that whilst we can support Trials, NHS DigiTrials will not be conducting trials itself, and can not control their results.

Communications plan – it was agreed that this agenda item did not need to be covered in the meeting due to time constraints. Members had read the paper and confirmed that they did not have any further comments or questions in relation to the plan.

The Board made a commitment to “Plain English” principles. For example, glossaries should be made available for technical terms and acronyms should be spelled out at first use. The Comms team will help with this effort.

Stakeholder Engagement plan - The stakeholder plan was briefly discussed.

It was emphasised how important it is for members, particularly Executive members, to fully engage with the Stakeholder Engagement plan, in order to understand what all types of potential clients want from the DigiTrials feasibility service A call has been scheduled with the Executive members to ensure this.

The Board reviewed information on the level of current UK clinical trial activity.

A requirement of HDR UK is that the Hub be sustainable by 3 years. The Board recognised that further grant funding from HDR UK was very unlikely. Consequently, charges will have to be made that ensure the continued functioning of the Hub and enhancements to meet evolving needs.

In addition, Board members continue to research opportunities to secure additional investment (always in line with best practice guidelines issues by NHSX, HDR UK, and relevant policy bodies). One such example is the ‘Strengths and Places fund’ administered by Research England.

Further work will be undertaken to refine what might be a sustainable position and consider what charging approach might deliver this. The patient perspective is key and patient will be involved both through membership of this Board and the PPIE workstream activities.

A discussion should take place with the NIHR Clinical Research Network, which supports queries from a range of clinical trial organisations, to understand more about how their financial model works.

Consortium Agreement update:

The intention was to issue the draft today (31st January 2020) to HDR UK for approval.

A call is scheduled to discuss the award letter and any outstanding issues. It was emphasised that a side letter will be requested, as the award letter still refers to the requirements of Milestone 3. The side letter is being requested to provide assurance that we are not going to be held to the delivery of Milestone 3 (which is scheduled beyond the end of the 18 month funding provided by HDR UK).