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What Sage minutes say about R&D, trials and data

Image: Number 10 [CC BY-NC-ND 2.0], via Flickr

A timeline of the released minutes details the group’s evolving thinking and actions

On 29 May, the government’s Scientific Advisory Group for Emergencies made the precedented move of releasing its meeting minutes while an emergency is ongoing and the group still convening.

The move follows months of criticisms over its secrecy, and provides a first-of-a-kind insight into the advisory group’s thinking while the emergency continues.

Here’s a timeline of key mentions of issues related to research, including trials, diagnostics, drugs, vaccines—and data challenges.

ON R&D AND SCIENCE

2nd Meeting: 28 January

A separate group has been convened outside Sage to consider how UK science can contribute to the international effort to tackle the outbreak.

8th Meeting: 18 February

Discussions are taking place across Government on how researchers can access clinical samples.

Sage secretariat to explore how to create a single, accessible repository for relevant papers on Covid-19.

11th Meeting: 27 February

Action: UK academic modelling groups (Imperial, Oxford, London School of Hygiene and Tropical Medicine) and NHS planners to organise a working group (in week starting 2 March 2020) to analyse key clinical variables for reasonable worst case planning for the NHS: for review by SPI-M and then discussion at Sage.

12th Meeting: 3 March

Action: PHE to…advise where there are evidence gaps requiring rapid research.

17th Meeting: 18 March

Future Sage meetings will consider broader aspects of Covid-19 including clinical science, genetics, virology, and treatments and vaccines.

19th Meeting: 26 March

Sage will focus on clinical trials, (including when we might have meaningful results), treatments and vaccine options.

21st Meeting: 31 March

Sage discussed priorities for research and discussion in the coming weeks and agreed some additional topics.

ON DATA

4th Meeting: 4 February

Lack of data sharing is seriously hampering understanding of WN-CoV.

Action: FCO to work with CMO and DHSC Comms to ensure there is a coordinated message coming from the UK on the need for greater sharing of data internationally.

5th meeting: 6 February

Action: FCO and DfID to work with SPI-M secretariat to finalise the detailed breakdown of data required from Chinese and other national authorities, and the routes through which this data should be shared. This request to be issued to all UK Heads of Mission in affected countries to pass to their host governments, with priority given to data from Japanese and Singaporean governments.

10th Meeting: 25 February

Sage agreed that information from FCO posts overseas would not provide suitable data for modelling purposes, although any clinical data will be useful. Google data is unlikely to be relevant at this stage of the outbreak because of diagnostic uncertainty.

Action: NHS England to work with NERVTAG to ensure data collection and clinical trial plans are implemented as soon as possible.

11th Meeting: 27 February

Action: NHS England to confirm finally with SPI-M the variables for which it needs numbers in order to model NHS demand.

16th Meeting: 16 March

Action: DHSC, NHSE and PHE to urgently work with NHSX and GO-Science on a data strategy, ensuring there is access to real-time data to track the UK epidemic and that is delivered in a form of use to operational leads, Sage and Cobra.

17th Meeting: 18 March

Sage discussed the importance of good quality and timely data…An NHSX hub should be in place from early next week ensuring a standardised, single source of data.

28th Meeting: 23 April

Sage asked that funders, including UKRI, actively engage in the Health Data Research (UK) process when making funding decisions on Sage priority questions relevant to health data.

Action: UKRI to publish ‘Research Questions for Covid-19’ on its Covid-19 web portal, subject to Sage secretariat confirmation; UKRI to liaise with John Aston and Andrew Morris on how to link questions in Health Data Research paper to its Covid-19 web portal.

 

ON TESTS, TRIALS, DRUGS AND VACCINES

4th Meeting: 4 February

Although the UK is building regional diagnostic capability within weeks, overall capacity is limited. Capacity cannot be substantially increased during this winter influenza season.

5th meeting: 6 February

It is not possible for the UK to accelerate diagnostic capability to include Covid-19 alongside regular flu testing in time for the onset of winter flu season 2020-21.

8th Meeting: 18 February

Sage agreed it is essential that the UK plans for how it will handle clinical trials and treatment should there be an outbreak of Covid-19 in the UK.

Discussions are taking place across Government on how researchers can access clinical samples. An access committee, coordinated by UKRI, is being set up to balance the needs of the scientific community and consider what will have a demonstrable impact on controlling the epidemic.

It is essential that the UK agrees principles for clinical trials and treatment should an outbreak occur on the UK, learning lessons from previous epidemics such as Ebola in West Africa and severe flu in the UK. This will support NHS planning.

Action: NERVTAG (with dCMO) to provide advice on principles for trialling Covid-19 treatments in the UK.

10th Meeting: 25 February

Action: NHS England to work with NERVTAG to ensure data collection and clinical trial plans are implemented as soon as possible.

11th Meeting: 27 February

NERVTAG is reviewing a range of therapies and related trial designs that NHS settings can realistically implement.

16th Meeting: 16 March

Action: PHE to develop a proposal for ramping up antibody serology and diagnostic testing capacity, seeking input from DSTL and the National Laboratories Alliance.

17th Meeting: 18 March

Future Sage meetings will consider broader aspects of Covid-19 including clinical science, genetics, virology, and treatments and vaccines.

18th meeting: 23 March

Action: dCMO and DHSC with NERVTAG chair consider how to set up a UK forum to coordinate clinical trials. This should include protocols for adding extra testing arms if needed.

Action: dCMO to consider what UK manufacturing capabilities are required to support clinical trial supply chain.

19th Meeting: 26 March

Sage will focus on clinical trials, (including when we might have meaningful results), treatments and vaccine options.

23rd Meeting: 7 April

Sage secretariat to provide summary of key science questions [for the tracking app] to NHSX. NHSX to return to Sage having considered these questions, for Sage to validate the approach and advise on its coordination with other measures.

28th Meeting: 23 April

Work is underway to engage with international biotech and vaccine companies; and to develop UK vaccine manufacturing capacity in the short and longer term.

On therapeutics, the UK has initiated clinical trials in primary care, and for patients in hospital and in ICU, focusing on repurposed medicines…there is a separate focus on alternative treatments including novel, pre-licensed compounds with urgent trials starting shortly.

30th Meeting: 30 April

Sage noted the challenges of manufacturing Remdesivir and the importance of funding trials for therapeutics as well as for vaccines.

Sage was updated on the status of the Oxford and Imperial vaccine trials—and noted the importance of innovative trial design.