Minutes of the meeting on 3 April 2019

The meeting was held between 11am–3pm at The Wesley Hotel, Euston House, 81-103 Euston Street, London NW1 2EZ

Expert group members

HRA staff

1.         Welcome and introductions

Professor Andrew George welcomed all to the Research Transparency Strategy Group, and apologies from Dr Matt Westmore and Professor Sir Steve O’Rahilly were noted.

2.         What problem are we trying to fix?

The meeting opened by highlighting the importance of research transparency in ensuring ethical research practices that protect and promotes the interest of participants are in place.

The Group considered a background paper and presentation exploring the current legal and policy framework supporting research transparency. The research community recognises the importance of research transparency and there is growing consensus that research should take place in public view. However, analysis in two particular aspects of transparency - around the registration of clinical trials and posting summary results of clinical trials of investigational medicinal products (CTIMPs) - shows that performance does not always meet the requirements.

The Group discussed the possible reasons for poor transparency performance, particularly in non-commercial research. These reasons include:

·              lack of resource in non-commercial research for complying with transparency requirements – this is increasingly built into grant applications, though not universally

·              practical reporting difficulties - trial trackers and databases have some limitations, particularly for some trial designs, and there are currently technical difficulties with the IT system for uploading summary results to the EU Clinical Trials Register.

None of this is to say that the status quo should be accepted. Rather, if the strategy is to be effective, we need to understand any barriers and help to address them to improve performance.

3.         What should the strategy do and be?

The House of Commons Science and Technology Committee made a number of recommendations to the HRA, with the aim of improving transparency around clinical trials. The key recommendations are to:

·              develop a research transparency strategy

·              submit a business case to the DHSC for any additional funding needed

·              consider what further legal powers might be necessary.

The HRA has accepted the recommendation to drive improvements in transparency and develop a research transparency strategy. The Group agreed that its role is to with the HRA to develop an ambitious yet feasible strategy for achieving research transparency that will be recommended to the HRA Board to take forward.

4.         Discussion

The Group discussed whether the strategy should include an ambition, so that is clear what we want to achieve and whether the strategy should include targets and implementation phases. The Group agreed that an ambition or vision is important and liked the principles suggested, with some amendments. It was agreed that the HRA would develop an outline for the strategy for consideration before the next meeting.

The Group agreed that it is important to agree what we want to achieve through this work and why. It is to promote open science, where other researchers can replicate studies and benefit from access to study data and tissue? Or it is to promote openness about research; to create a public record of ongoing and completed research, with well-described findings?

If the purpose of the strategy is to promote open science, then it might question the structure and contents of some reporting requirements, such as publishing summary results on the EU Clinical Trials Register and whether the public information does allow a study to be replicated?

If the purpose of the strategy is to create a public record of research, members agreed that the HRA is well-placed to do this. It has direct access to study information through the approvals process and has both national reach (through joint working with the devolved administrations) and oversight of all health and social care research. It was suggested that the primary outcome of a study, described in the initial application, could be used to follow up on publication, and monitor for reporting bias, whether this is done by the HRA or others.

The Group discussed the HRA’s research summaries database as a great starting point, that could be improved to include all necessary information (pulled through from the application portal) and provide a single, trusted, place for information about studies.

How to gather post study and publication information was discussed. The final study report could be used for this but would need to be standardised and mandated (and enforced) to provide consistent publication information. Alternatively, the HRA could pull this information from other sources already collecting it, such as Researchfish. The Group agreed that any increase in burden on the community should be minimised and justified.

The Group had an initial discussion about whether the HRA should strengthen requirements or take action in the case of non-compliance. This might include:

·              requiring proof of registration before issuing approval, rather than it being a condition of approval

·              considering past transparency performance when considering new applications for approval

It was agreed that HRA would draft policy options for discussion at the next meeting.

Actions:

HRA to develop an outline for the strategy for consideration before the next meeting.

HRA to draft policy options for discussion at the next meeting.

5.         Agree scope and high-level objectives

The Group agreed that the strategy should initially focus on clinical trials (including CTIMPs, device trials and other trials). There are existing legal and policy requirements in place for these studies and more infrastructure to support transparency. However, the strategy should articulate an ambition that is suitable for all study types and commit to increasing performance in this area in the future.

The Group recognised that there is a need to balance quality with speed. The HRA must continue to ensure that the UK remains an attractive place for research to take place, ensuring that there are no unnecessary delays, whilst helping to maintain the UK’s reputation for high quality, ethical research.

The Group agreed that the ambition should consist of the following themes:

·              Trust

·              Diversity

·              Accountability

·              Empowerment

·              Democracy

6. Engagement and consultation

The Group agreed that engagement and consultation are crucial to the success of the research transparency strategy. Giving patients and professionals the opportunity to shape the strategy will make it more likely to be a success. The Group agreed that we should explain to the research community what we are proposing to do and why, and provide opportunities for them to give feedback, particularly where there will be changes to requirements and expectations.

The Group agreed that it will be difficult to finalise an engagement plan in terms of the methods that will be used and the stakeholders that will be targeted until there is further detail on the contents of the strategy. They agreed that we should offer different ways of giving feedback, whilst being careful not to commit to more engagement activity than we have time and resources to deliver.

It was also agreed that the following stakeholders/partners should be considered in our engagement plan:

·              Sponsors

·              Researchers

·              Public and patients

·              Funders and charities

·              Research Ethics Committees

·              Industry

·              NIHR

·              NHS Trusts

·              Publishers

7.         Expert Group communications and transparency

The Group discussed how its work should be communicated and what information should be published on the HRA website.

The Group agreed that the approach to communications about the strategy and its development should be proactive and open. A list of the Group members, with short bios, has already been published on the website. The Group agreed that the Terms of reference and the agenda and minutes of each meeting should also be published.

All agreed that it would be useful to also publish more informal communications – such as blogs - about the Group’s work to keep interested stakeholders up to date.

The Group agreed that minutes will be circulated to the Group to check for accuracy before publication.

8.         Expert Group terms of reference

Group members agreed the terms of reference, with a few minor amendments.

9.         Timetable/contents of next two meetings

The Group members agreed to the proposed timelines and the contents of the next two meetings. The next meeting is to be held on 8 May in London.