23 January 2014

Present

Professor Julietta Patnick (Chair)

Professor Dame Valerie Beral Kath Moser

Professor Sir Richard Peto

Professor Malcolm Reed Sarah Sellars

Margot Wheaton

Dr Robin Wilson Richard Winder

In attendance

Keith Shaw

Hayley Abbiss (notes)

Apologies

Dr Lucy Carpenter

Dr Kevin Fenton

Professor Amanda Ramirez Professor

Sir Mike Richards

Documents circulated in advance:

• Agenda
• Minutes of TMG meeting 9 January 2013
• Trial progress as at January 2014
• Data progress as at January 2014
• Report on study population data for the first 4 years of the trial
• Report on screening data for the first 3 years of the trial
• Report of the parliamentary inquiry into older age and breast cancer

1. Welcome and introductions

Keith Shaw (KS) was welcomed to the meeting. KS is Data Manager for the trial (Cancer Epidemiology Unit).

Kevin Fenton (KF), Director of Health and Wellbeing for Public Health England (PHE), has agreed to join the Trial Management Group. He sent apologies due to a prior commitment.

Apologies were received from Lucy Carpenter (LC) and Mike Richards.

Amanda Ramirez (AR) has resigned following a change in her job which means she is now focussing on clinical work.

2. Minutes of the last meeting (9 January 2013) and matters arising

The minutes of the last meeting were accepted as an accurate record.

Matters arising:

Julietta Patnick (JP) reported a positive meeting recently with Cancer Research-UK who were very supportive of the NHS Breast Screening Programme.

JP reported that she had received a complaint from Susan Bewley in November 2013 expressing concerns about the ethical and scientific underpinning of the trial.

3. Trial update (KM)

a)    Randomisation, numbers, data

There has been much progress in obtaining trial data over the last year and KS has been central in managing this process. Reports were circulated in advance of the meeting. KS confirmed there have been no issues with accessing the data from the Quality Assurance Reference Centres (QARCs) since their transfer from the NHS to PHE.

There are 9 breast screening units that have not yet started randomising. 6 of these plan to start by the end of March 2014. There is no start date for the remaining three. Sarah Sellars (SS) reported that from April 2015 all women are likely to be screened using digital machines.

Valerie Beral (VB) requested that all future reports be marked as confidential and that all such material should be treated confidentially and not discussed outside the TMG.

b)   Ethical approval, protocol

A substantial amendment (to cover linkage to HES and other NHS datasets; offer screening throughout their 70s to women randomised in aged 71-73; revise patient leaflet) was submitted to the Research Ethics Committee (REC) February 2013 but was not approved.

Julietta Patnick (JP), the principal investigator, has since had discussions with the Chair of the REC to clarify their concerns. The main issues are around the leaflet and informing the control group.

It had been decided that rather than put in an appeal, it was better to submit a new substantial amendment that only covered linkage to NHS datasets, and a revised patient leaflet.

JP and KM have been redrafting the leaflet, and Public Health England is now assisting in reformatting the leaflet. As soon as the leaflet is finalised we will go back to the REC with a new substantial amendment. References in the protocol to continuing to send invitations to women over 73 will be removed.

SS stressed the importance of the new leaflet not looking similar to the NHSBSP information leaflet that is sent to all women as this could cause confusion. MW was concerned that if the new leaflet was bigger than.at present it would impact on postage costs.

It was agreed that it was urgent to finalise the new leaflet and go back to the REC as soon as possible.

Malcolm Reed (MR) requested that the new leaflet is sent to the TMG before it is submitted to Ethics with the new substantial amendment.

Action: KM to send patient information leaflet to TMG before submitting it to the REC with the substantial amendment.

4. Discussion of future plans

Funding is needed to continue to offer screening to women (who were randomised in aged 71-73) throughout their 70s. JP estimated that offering screening to 74-76 year olds would cost an extra £4 million per annum. Due to cuts within the NHS and PHE they will not be able to provide additional funding. JP confirmed PHE are supportive of the TMG reorganising current funds in order to generate funding for offering screening to 74-76 year olds.

The Health Technology Assessment Programme will not fund the continuation of an existing trial. Richard Winder asked whether approaching public/private partnerships for funding was an option. The NIHR was suggested as a potential funder. RP warned it would be unwise to seek any commercial sponsorship and VB agreed funding would need to be at ‘arms-length’. It was agreed that the TMG should get approval from the Ethics Committee, calculate what funding is required, and then talk to Professor Dame Sally Davies.

JP highlighted the main problems would be obtaining funding and recruiting services. It was discussed whether offering one more screening round was deliverable. Margot Wheaton (MW) stressed that staffing levels across the service are currently at a critical level.

MR suggested a 3 prong strategy – (i) getting the protocol right (ii) obtaining ethics approval (iii) obtaining funding. The costs would need to be worked out in parallel with this.

JP is expecting to be called to give evidence to the Commons Select Committee on Science and Technology inquiry into National Health Screening. VB advised that she will be providing written evidence to the Committee. The deadline is 26 February 2014.

PHE supports the continuation of randomisation beyond the two screening rounds currently agreed. They will require good evidence before deciding to extend, or not, routine screening to women under age 50 and over age 70, and support randomising until such a point is reached. Evidence for the younger women should be available in the early 2020s, for the older women in the late 2020s. The primary endpoints are breast cancer mortality up to age 60 for the younger, and up to age 80 for the older, women. The Data Monitoring and Ethics Committee will advise the TMG when, in their opinion, there is proof beyond any reasonable doubt that an additional screening invitation at ages 47-49 years or at ages 71-73 years will reduce breast cancer mortality by age 60 or by age 80 respectively. It will then be up to the TMG to decide what to do.

5. Any other business

TMG membership.

SS, MW and Richard Winder are due to retire by Jan 2015. They were asked if they would be interested in staying on the TMG to contribute their expertise – all said they would be. Mike Richards has stepped back from the TMG but agreed to remain a semi-sleeping partner. Amanda Ramirez has resigned her membership of the TMG. Robin Wilson plans to retire in 2016 and so we will need to find a radiologist to replace him.

It was agreed to invite someone currently working in the screening programme. Suggestions included Kim Stoddard, Programme Manager for North London Breast Screening Service; Monica Dale, Breast Screening Superintendent Radiographer. RP proposed inviting Dr Hongchao Pan, from CTSU, who is involved in the Early Breast Cancer Trialists’ Collaborative Group.

Publications.

It was agreed that we cannot write substantive papers at this stage. We plan to publish the protocol once it has been finalised, possibly in Lancet Oncology or Health Informatics; some process data could be included.

Next years meeting.

MR requested a longer meeting next year in order to allow for academic discussions and to look at detailed numbers, costs and times. It was proposed to include some presentations including one from RP on screening women through their 70’s. JP requested that a time line be drawn up. The DMEC will be invited to observe the TMG meeting and attend the presentations. It was agreed that the DMEC meeting should follow on after the TMG meeting.

Action: KM to submit the new substantial amendment including the revised patient information leaflet to the Ethics Committee, as soon as possible.

Action: VB to submit written evidence to Commons Select Committee

Action: JP/KM to invite new members to the TMG

6.Date of next meeting

TBA