This consultation describes our plans for realising our research transparency mission. We are keen to hear your views about them, so that our final strategy is bold but feasible.
Our plans and proposals fall into three categories:
Changes we will make
These are changes that we have already decided to make. We have either started the work or will start soon. In the survey, we ask you to help us to prioritise these changes and make any suggestions for additional activities.
Changes we plan to make
These are areas where we plan to make changes but are seeking views about how to do that. We present a number of different approaches and ask for your views. This will help us to get the strategy right.
Changes we could make
These are further changes we could make if individual research sponsors do not fulfil their transparency responsibilities. We’d like to hear your views about them.
Changes we will make
Supporting good practice and making compliance easier
We have already decided to make a number of changes to support good practice and make compliance easier. We plan to:
- be clearer about what we expect of sponsors and researchers at the different stages of the process
- develop new learning packages to support them
- share best practice and celebrate improvement
- make it clear what information from applicants we will make public and what we will share with others
- introduce automated reminders for researchers and sponsors to submit transparency data and to view the status of their studies
- give sponsors and researchers feedback on their transparency performance.
In the survey, we ask you to help us prioritise these changes and make any suggestions for additional activities.
Making transparency performance clear
We want to make it clear when researchers and sponsors are not making their research public. To do that, we plan to:
- flag up individual studies where transparency information is overdue
- share transparency performance data with funders, other regulators and registries.
In the survey, we ask you for feedback about these changes and any suggestions for additional activities.
Sharing the results of research studies with the people who took part
We want to make sure that the people who take part in a study can access the research findings in a format they can understand. This respects participants and acknowledges their contribution.
To ensure better feedback to participants, we have already decided to:
- change the question we ask applicants from whether they will share study results with participants to how and when they will share them (where appropriate)
- ask sponsors to submit a lay summary of the study results to the HRA (no longer than 12 months after the end of the study), which we will then publish.
In the survey, we ask you to make any suggestions for
Changes we plan to make
Making sure all clinical trials are registered
Information about each clinical trial should be made public before the first patient is recruited, unless the sponsor has permission to delay this to a later stage. This is called registration. Clinical trials of medicines are automatically registered on the EU Clinical Trials Register.
However, despite it being a condition of approval, around 30 per cent of clinical trials of medical devices, surgery, public health and behavioural interventions are not registered (BMJ Open). We want to fix this.
We expect sponsors to register their study before recruitment begins (unless they request a deferral), which can happen a few months after they seek approval. We do not ask them to give us the details when they do register. For the majority (around 90 per cent) of sponsors we know that reminding them to register is effective.
In our survey, we seek views about the most reasonable and appropriate ways that we could ensure registration of all clinical trials:
- Researchers must register their study before seeking approval. The advantage of this would be that 100% of studies are registered (except those with a deferral). However, the disadvantage would be that those studies which are not approved would have been registered.
- The HRA supplies data about clinical trials directly to a registry. The advantage of this would be that 100% of studies are registered (except those with a deferral) and the sponsor has less to do. The disadvantage is the cost of building the systems to send the data to a registry.
- The HRA becomes a registry itself. The advantage of this would be that there is no need to build the systems to send the data to a registry. The disadvantage would be that it may duplicate the work of existing registries.
Monitoring sponsors’ and researchers’ transparency performance in clinical trials
It is important that the results of individual clinical trials are shared publicly. Publishing results in a peer-reviewed journal isn’t always achievable or accessible to the public. As a minimum, the record in the registry should be kept updated as the study progresses, including adding a summary of the results.
While it is a legal requirement for clinical trials of medicines, around 25 per cent of UK sponsors do not report results on time (data from EU Trials Tracker). For other types of clinical trials, where there is no legal requirement, the reporting rate is likely to be lower. We plan to change our processes for all clinical trials to address this challenge.
Currently, applicants seeking approval from the HRA for their research are asked how they will disseminate the results of the study, including to the people who took part in it. On approval, they are told that they must submit a final report within 12 months of the end of the study. However, there is no defined data-set for this and current resources don’t allow us to chase overdue reports.
We plan to make it clearer to applicants at the time of study approval that they should send us a final report 12 months after the study has ended. We will also take a more proactive approach to prompt sponsors to keep their study information up to date and to submit final reports. We will publish information we receive on the public platform or provide a link to information held in a registry or publication. Some of this activity will require additional funding.
The process would look like this:
In the survey, we ask to what extent these steps will improve the reporting of results from clinical trials. We also ask for suggestions about what else we could do.
Changes we could make
We believe that the plans and proposals in this strategy will bring about significant improvements in research transparency. However, we have developed some possible further steps we could take for dealing with individual sponsors who do not fulfil their research transparency responsibilities.
We are not seeking views about detailed measures at this stage, as we are keen to hear your views about the approaches we could take. If we decide to pursue specific measures based on the feedback we receive, we will formally consult on them.
Taking actions under existing legislation
If a sponsor fails to fulfil their transparency responsibilities, we could:
- publish an annual ‘transparency league table’ highlighting individual studies which have information that is overdue
- take into consideration the extent to which they have fulfilled their transparency responsibilities in relation to their previous studies, when reviewing new studies for approval.
Action that would need a change in legislation
- fining sponsors with very poor transparency compliance rates.
In deciding whether to take these actions, we need to consider not only what could be effective, but also what is reasonable. We would also only take action once sponsors had had a reasonable opportunity to comply or to make a case for why they were unable to comply.
In the survey, we ask to what extent these actions would be appropriate.
Things that might make it difficult to be transparent
Researchers and sponsors have told us about things that make it difficult to comply with transparency requirements. Some of them are wider cultural or institutional factors and others are practical hurdles. Here are some examples:
- limitations in the EU register make it hard to report results about certain types of clinical trials of new medicines
- delays in the system for updating records on the EU register mean that results still appear to be outstanding when they are not
- difficulties in reporting the results of trials because trial staff have left the sponsor organisation
- lack of resources and clarity about responsibilities in sponsor organisations to adequately monitor and fulfil transparency requirements
- lack of clarity about the transparency requirements for different types of studies
- institutional pressures to publish in a peer-reviewed journal and apply for further research funding, rather than fulfilling transparency responsibilities on existing studies.
We are not saying that these reported difficulties are acceptable reasons for failing to fulfil transparency responsibilities.
However, we want to understand the difficulties so that we can help to address them where possible – and we are already working on that in some areas. We also want to make sure the changes we make are feasible for sponsors and researchers.
In the survey, we ask for
views about these difficulties and for suggestions about what else makes it
difficult to be transparent. We also ask for feedback about what could make it