30 April 2020

Present

Professor Julietta Patnick (Chair) (JP)

Ms Krys Baker (KB)

Dr Isobel Barnes (IB)

Professor Dame Valerie Beral (VB)

Mrs Claire Borrelli (CB)

Dr Lucy Carpenter (LC)

Mrs Jacquie Jenkins (JJ)

Dr Hongchao Pan (HCP)

Professor Sir Richard Peto (RP)

Professor Malcolm Reed (MR)

Professor Gillian Reeves (GR)

Professor Sir Mike Richards (MAR)

Mr Keith Shaw (KS)

Dr Louise Wilkinson (LW)

Dr Suzanne Wright (SW)

Apologies 

Professor David Hunter (DH)

Mrs Annie Hogg (AH)

1. Welcome and Introductions

JP welcomed TMG members

2. Minutes of the last meeting (25/03/2019) and matters arising

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

COVID-19

JJ explained that all Breast Screening Units in England have closed according to local NHS Trust policies on social distancing. Every screening unit will re-open for breast screening activities independently when local social distancing measures are achieved. It is not clear whether mobile screening units will be able to offer screening due to the lack of space for distancing and handwashing facilities. JJ will keep the AgeX co-ordinating centre informed of the re-opening of each Breast Screening Unit.

The TMG members recognised that while it is important for TMG members to champion the trial, the trial would need to wait to start randomising again until the Breast Screening Centres had caught up with all of their outstanding NHS commitments, which would take longer than usual due to new social distancing measures that would need to be put in place. The trial investigators recognised that randomisations into AgeX may need to be halted for some time, but that it was important to continue follow up of existing trial participants. It was agreed that the Investigators would use this time to catch up on all data provisions from external sources.

Action: JJ inform AgeX Trial co-ordinating centre when a BSU re-opens for screening.

3. Numbers randomised

About 4.0 million women were randomised up to end March 2019, 2.5 million aged

<50 years and 1.5 million aged 71+ years. The numbers randomised up to end March 2020 were not yet available. SW explained that from April to June 2019 a mailing company contracted by some screening centres to send out screening invitations had failed to enclose the AgeX Participant Information Sheet with the invitations. PHE is working to identify these women and remove them from any information sent to the trial investigators. No more than 5000 women from 8 NHS Trusts appear to be involved.

Some women randomised to be invited for screening in early 2020 who had not been screened or invited before COVID-19 lockdown March 2020 may not have been screened because of the suspension of breast screening services by individual NHS Trusts. It was important that they be invited when the screening centres start working again.

4. Progress report

4.1   Following the 2018 breast screening incident the final report of the Parliamentary enquiry in December 2018 and recommended that AgeX should continue “until its planned end in 2026”. Formal Government statements in both Houses accepted this recommendation.

4.2   The Parliamentary enquiry delayed data collection and record linkage, but not randomisation. In late 2018 PHE changed its definition of the age when women were eligible for routine screening, the AgeX protocol was revised accordingly. There have been substantial improvements in data linkage since 2019.

4.3   In December 2018, Cancer Research UK funded fully the application for continued financial support during 2019-2024 for some members of the AgeX Trial Co-ordinating Committee, based in the Nuffield Department of Population Health in Oxford.

5. DMEC report to TMG March 2020

The DMEC report was presented to the TMG congratulating the breast screening units and trial team on randomisations and improved data linkages. There were no concerns raised from the DMEC.

6. Communications and Correspondence 

It was noted that, as reported in previous meetings that communication directly from participants comprised mainly small numbers of women wishing to opt-out of the trial and asking to be included in the trial after age 71 and in the 47-49 year age groups. Other queries included questions based on personal experiences and asking for advice.

7. Any Other Business

No other business was raised.

8. Date of next meeting 

Spring 2021.