What have the HRA said?

All trials must gain approval from Research Ethics Committees before they can go ahead. The HRA have agreed that they will make registration of clinical trials within an agreed time frame a condition of REC approval from September 2013. This will affect all trials of drugs, devices, therapies and diagnostics taking place in the NHS. They will work with research funders and sponsors to set standards for the publication and dissemination of research outcomes, dependent on the type of research.

The detailed data from clinical trials are also valuable for conducting further analyses. This must be handled very carefully to ensure no identifiable information is accessed by researchers. However there is a concern that the data collected by some research studies cannot be re-used by researchers in this way because the original consent form signed by the patient explicitly excluded data sharing. The HRA are planning to include advice and recommended text in consent forms in future to ensure that consent is in place at the outset, avoiding any barriers to future data sharing and access to tissue.

HRA have also agreed to work with others on overcoming other barriers to transparency including:

• Tackling unhelpful perceptions that negative findings are not valuable
• Encouraging greater awareness of online journals where these findings can be published
• Clarifying how early release of data sits with later peer reviewed publication, and agreeing sensible frameworks with publishers to dispel fears that early release will prevent publication

Why is this important?

Patients choose to take part in research because they hope that the treatment will benefit them, and because they want to improve treatment for others in the future. To ensure this can happen, we believe trials must be registered and the findings of research made available for others to learn from.

It is in the interest of everyone that research is published once it is complete. Funders demand it as part of their terms and conditions of awards, and regulators expect it as part of granting the approval to carry out the work. But many fear that some research is not published, and that this lack of transparency will lead to a hole in our knowledge with potential impact on safety or causing unnecessary duplication.

What will happen next?

HRA have identified some areas of transparency where more work is needed. They will be looking at how to ensure that researchers adhere to their plans for tissues and data that arise from research to be made available for research. They will also be working with the patients to determine the best ways for the results of research  to be presented back to participants.

At the end of the breakfast, speakers and guests agreed to write to the Times to highlight the key messages of the meeting:

Long-term funding is needed from the Government to ensure the continuation of the UK as a place blessed with a vibrant research eco-system

Sir, Yesterday MPs, peers and leaders of the medical research community met to discuss the benefits of science to society and our country’s health, and to our economy. Science has been put centre-stage in the Government’s plan to build a sustainable economic recovery. We must now build on this conviction and not lose the momentum in the forthcoming spending round.
The UK is blessed with a vibrant research eco-system, made possible by public, private and charitable funders that make a unique contribution to the science base. Long-term commitment from the Government is needed to maintain confidence and to leverage further investment from charities and industry. The Francis Crick Institute, a biomedical research centre funded by the public and charities in partnership, is a prime example of this in practice, and will act as a beacon to attract private investment to the UK.

Our world-class education system provides the skilled people essential to our high-tech economy, and the NHS sets us apart as a global destination for medical research. We should not risk these valuable assets now.

With only 4 per cent of the world’s scientists, the UK is responsible for 14 of the top 100 medicines in use today (second only to the US). As Venki Ramakrishnan eloquently argued last week (Opinion, May 8) we must maintain this position by keeping pace with our competitors. Continued government investment in R&D now will lead to life-changing advances that will benefit people’s health and wellbeing and create new industries to drive economic growth.

Lord Turnberg, Chair All-Party Parliamentary Group on Medical Research; Sir Paul Nurse, Chief Executive, The Francis Crick Institute and President of the Royal Society; Dr Harpal Kumar, Chief Executive, Cancer Research UK; Professor Patrick Vallance, President, Pharmaceuticals Research and Development, GlaxoSmithKline; Lord Darzi of Denham; Professor Sir John Tooke, President of the Academy of Medical Sciences; Dr Julian Huppert, MP; Andrew Miller, MP, Chair, House of Commons Science & Technology Select Committee; Lord Willis of Knaresborough, Chair, Association of Medical Research Charities; Dr David Lynn, Director, Strategic Planning and Policy, Wellcome Trust; Sharmila Nebhrajani, Chief Executive, Association of Medical Research Charities; Dr Liam O’Toole, Chief Executive, Arthritis Research UK; Jeremy Lefroy, MP; Baroness Jolly; Sir Peter Bottomley, MP; Professor John Wass, Academic Vice President, Royal College of Physicians; Dr Kieran Breen, Director of Research and Development, Parkinson’s UK; Professor Peter Weissberg, Medical Director, British Heart Foundation; Professor Sir Robert Lechler, Executive Director, King’s Health Partners, and Vice-Principal (Health) King’s College London; Stephen Whitehead, Chief Executive, the Association of British Pharmaceutical Industry

Why is this happening now?

Government departments are in the midst of putting together their bids for government funds as the Treasury takes forward its latest spending round, reviewing the current spending allocations and agreeing budgets for 2015-16. The Treasury plans to announce their decisions on 26 June when we will find out  how much each government department will be getting. Each Department will then need to decide how to share their allocation out across their spending responsibilities.

Some areas including health and education are protected and won’t be subject to direct cuts. But the Department for Business, Innovation and Skills which funds the research councils and universities among other responsibilities does not have its funding protected. As a result medical research charities, alongside everyone funding research in the UK, are particularly concerned about the Department’s allocation.

What next?

We have been gathering evidence which we have been sharing with government departments, holding a series of workshops with BIS to better understand the interplay between public, charity and industry funders of research in the UK.

This spending round is for a relatively short term – we’re expecting a full-scale comprehensive spending review in the next Parliament after the next general election, which is due in May 2015.

We found that while healthcare professionals appear to be universally agreed that the NHS should support research into treatments for patients, they are less sure of their own role. Many have experienced barriers to taking part in research, and some lack confidence in talking about research with their patients, and are not familiar with resources and organisations that can help them get involved. We also found that many healthcare professionals are rarely asked about research opportunities by their patients.

To address these challenges, we have developed a vision for research in the NHS which lays out practical steps NHS bodies and those working with the NHS can take to create an NHS where:

• Every patient is offered opportunities to be involved in research
• All NHS staff see the importance of research
• The NHS conducts high-quality research and adopts new treatments.

We hope this will begin an ongoing conversation between all partners supporting medical research, helping us to work in partnership to promote research and the rapid adoption of new treatments throughout the NHS to benefit patients.

What did our survey find?

Jointly with Arthritis Research UK, Breast Cancer Campaign and the British Heart Foundation, we commissioned ComRes to survey NHS healthcare professionals – GPs, Nurses and Hospital Doctors – to better understand their experiences of, and attitudes towards, research.

We found that while there was near universal agreement that the it is important for the NHS to support research, 91% had experienced barriers to taking part in research – including lack of time (62%), funding (30%), practical support (27%) and difficulties navigating regulation (24%).

And while the majority believed that it is very important for the NHS to support research into treatments for patients, they were less sure of their own role with less than a quarter of GPs (22%) feeling that it was important for them to be involved personally. For these GPs, lack of time was a key issue, with nearly three quarters (73%) naming it as a barrier preventing them from getting involved in research. This is particularly concerning as GPs represent the main NHS contact with patients, so they can play a vital role by giving patients opportunities to take part in research, conducting innovative research themselves and facilitating research through commissioning.

On the other hand patients tell us they are keen to take part in research, especially in clinical trials. 72% of the people we asked in a MORI poll in 2011 told us that they would like to be offered opportunities to be involved in trials of new medicines or treatments if they suffered from a health condition that affects their day-to-day life.

But over half (53%) of healthcare professionals we asked told us they are asked by their patients about research opportunities less than once a year, if at all.

In fact, NIHR has just launched a campaign to address this and encourage people to ask about research. It’s OK to ask has been launched to mark clinical trials day which is next Monday, 20th May. The campaign is aimed at patients, medical professionals and the public to promote the fact that it’s OK to ask about clinical research.

But it is important that when they are asked by their patients about research, healthcare professionals are confident to talk about it. Many of those we polled told us they lack this confidence, with a third of nurses (31%) and GPs (34%) telling us that they are not very or not at all confident. Luckily lots of resources do exist for clinicians about medical research and how they and their patients can get involved. Many healthcare professionals reported using them but a fifth (20%) told us they don’t use any of the tailored information resources available and only around half of those asked knew something about the NIHR or NIHR Clinical Research Network.

So what are we doing about this?

The Health and Social Care Act 2012 for the first time placed duties on the Secretary of State, the new NHS England and Clinical Commissioning Groups to promote and support research in the NHS.

Everyone at the top is convinced of the case for making research a core role of the NHS and the NHS Constitution promises NHS patients that they will be “informed of research studies in which you may be eligible to participate”. But the question now is whether the NHS is ready and capable of implementing these grand ideas.

Our survey shows that we still have quite a way to go if we are going to ensure that every patients is offered the opportunity to take part in research, that all NHS staff see the importance of research and that the NHS conducts high-quality research and adopts new treatments rapidly to improve patient care. We are concerned that these duties to promote research must deliver in practice.

That is why, over the past six months we have worked in collaboration with our members and the wider medical and research communities to develop our vision for research in the NHS. This provides a clear set of guidelines that should help overcome some of the barriers patients, NHS staff and funders currently experience, enabling hiqh-quality research to become an integral part of what the NHS does.

We describe how every patient should be offered opportunities to take part in research wherever they live – from finding out about opportunities, helping identify questions that need to be answered to improve their care and shaping the design of research projects, to self-referring their interest to take part.

How all NHS staff should have the time, training and resources to be able to take part in research, and use research evidence to inform the care they give to their patients. That their research experience should be valued and rewarded and they should be given information and opportunities to become more involved in research should they want to.

And how all NHS bodies should share knowledge, accelerating the translation of research findings into improvements for patients and quickly adopting findings. And how the NHS can be open for research – fostering the development of research leaders and infrastructure, and ensuring the process of funding research in the NHS is clear and easy to navigate.

Our full report is packed with case studies of great work already underway to embed research throughout the NHS, involving patients and NHS staff. We’ve also produced a neat little summary of the calls.

What next?

Our vision and the findings of our survey are being launched in parliament this morning at a meeting of health-focused APPG Chairs, demonstrating that research is integral to improving treatments for people with all health conditions.

We recognise that we will all play a role in shaping the NHS of the future and this vision sets out practical steps that we can all take to promote this. We will be sharing the vision with those working in and with the NHS.

We hope this will begin an ongoing conversation between all partners supporting medical research, helping us to work in partnership to promote research and the rapid adoption of new treatments throughout the NHS to benefit patients.

The exam question set by the Committee was a pretty complex one, going something like this “What are the barriers to conducting trials in the UK and will the proposed new regulations make things any easier? And how can we create a more open and agile research environment that is both more productive and where public involvement is greater and public confidence is higher?”

How to do more clinical trials

This is a really importance topic to many AMRC members. Over a third of our member charities are currently funding clinical research – that might be drug trials, new surgical techniques, diagnostics or other interventions – and AMRC members fund 32% of 2600 studies in the NIHR portfolio. Of these, 14% (361 studies) are CTIMPS (clinical trials of investigational medicinal products), which are regulated by EU clinical trials legislation and so getting the regulation right is important – but even more important are the other practical things we can do within the UK to ease the progress of clinical research and trials.

We know for example that in some areas of research there is simply insufficient research capacity in the UK for charities to fund – 44% of Action on Hearing Loss research budget was  spent overseas in 2011 because of a lack of researchers in the UK working on hearing loss. And we know that research is an international business and that charities want to fund the best science for the benefit of patients and sometimes that is overseas. So we need to make sure that the environment in the UK really does help research to happen in our institutions and that we can attract the best talent to come to British universities.

Finding good researchers is perhaps half the battle but a clinical trial is nothing without participants.  Almost three quarters of the public have told us they want to take part in the research but they often have no idea how to become involved. And this is borne out by a recent NIHR “mystery shopper” survey, which found that found that 91% of hospitals did not have any public information about trials occurring there and of the 40 Patient Advice and Liaison Services (PALS) only 3 had any information on research.

There is a fantastic resource in the UK Clinical Trials Gateway – when I Googled clinical trials as a bit of my own research last night this great site came up in 0.14secs. But another NIHR Patient Survey showed that that 80% had not heard of UKCTG. So clearly the website needs more promotion and patients need to know that UKCTG is open for business.

Regulations are important but the world is changing

We hope that both the proposed EU Clinical Trials Regulation going through EU Parliament and the HRA and its NHS regulatory pilot currently underway make trials easier to conduct without compromising safety. But it is clear that the regulatory framework needs to be more agile and flexible to cope with emerging novel therapies, for example the combination of drugs and devices or biomarkers and the smaller sample sizes and more personalised medicines associated with stratified medicine and pharmacogenetics.

The outcomes of research should be public

The committee were very interested in the issues of what happens to research once it is completed. My fellow panellists and I all agreed that trials should be registered. In fact it has been long standing AMRC advice that charity funders should require in their T&Cs the publication of the findings of research within a suitable time frame (such as 1 year after completion – see our guidance Charities and medical research). In our recent survey we found that 80% of our members who conduct clinical research told us that they include a requirement in their T&Cs that research results should be published and 62% follow this up to check. We are looking at further ways to help charities monitor and enforce this.

And we know that negative findings can also really illuminate research questions – but we don’t yet have an obvious way to do that. But just publishing findings won’t be enough; making the outcomes of research public means also making those outcomes easily understandable to a lay reader. There are some fantastic examples of this, such as CancerHelpUK.

Are CSRs the answer?

The committee asked if wider use of Clinical Study Reports (CSRs) to the regulator would be helpful. CSRs are formal reports by the drug trial sponsor, usually a pharmaceutical company, university or hospital, which are a requirement when the study leads to drug licensing . These confidential reports contain detailed information right down to individual patient health records. Glenis Willmott, the MEP leading the new Clinical Trials Regulation through the EU Parliament, has recommended that CSRs should be a requirement for all studies covered by the legislation. We have some concerns about this:

• It places a huge burden and cost on academic researchers, especially those conducting small-scale or early trials (which do not currently require a CSR), as they do not have the resources or expertise to produce them
• These are vast documents running to many many volumes. They really are unlikely to be a helpful tool in practice for making research findings more easily or widely understood
• And there is a big question about how to protect the identifiable personal data these reports hold.

I believe that it is important that the outcomes of research are shared more openly. The public has often funded these projects and they should be able to see the results. More open dissemination of outcomes including negative findings might also reduce study duplication and encourage collaboration. And  providing researchers with access to underlying data for further research can also speed medical advance. But we have to make sure that public information is in a clear and readable form, and that data is shared without compromising patient confidentiality.

Background

Through research funding programmes and other initiatives, the EU aims to encourage innovation to support economic growth. Horizon 2020 is the main research funding stream and is part of the EU’s new strategy for growth, Europe 2020. It will begin in 2014 and run until 2020, MEPs are currently debating the size of the pot but it will probably be somewhere between 50 and 80 billion euros.

The Lords inquiry was interested to know whether EU research and innovation proposals were fit for purpose, whether they are being implemented effectively and what else could be done to support innovation and economic growth.

What did AMRC tell the inquiry?

We responded to the inquiry’s call for evidence, saying:

• Science is international. Coordination and collaboration across Europe is important to foster research and innovation. The EU plays an important role in facilitating these collaborations.
• Medical research charities are keen to engage with the EU and have valuable insights into policy development. However there are challenges that both charities and the EU must overcome. Increased transparency of EU processes and well-publicised consultations would increase participation, leading to more effective research and innovation proposals.
• The UK is a European leader in many research and technology areas, notably the life sciences, attracting international investment. It is important that the UK engages effectively in EU policy-making to ensure the UK and Europe can continue to attract global investors.
• Research and innovation proposals must work for everyone, including charities and patients.

What has the Committee said?

You can read the full report here.

• They recognised that it is important for the EU to consult relevant bodies when developing its policies and projects, specifically those in ‘niche’ R&I sectors such as health. They welcomed the extension of consultation periods from 8 to 12 weeks but called for more to be done to encourage engagement.
• It is important for the EU to monitor and evaluate projects in a consistent way to ensure money is being spent effectively and that lessons are learnt for future work.
• They were concerned that the private sector is not getting enough access to funds, noting that universities were much more successful at this. Calling on the EU to improve the accessibility of its programmes, the Committee said that the bureaucracy and complexity acts as a barrier to private sector participation, especially for SMEs without the resources to navigate complicated and inflexible funding processes. The long period between having a proposal accepted and actually getting the money was also seen as a problem.
• We are also pleased that they took on board our comments about a joined up approach across EU and UK government departments being necessary to make sure legislation in one area does not inadvertently impact on another area:

The AMRC …. said that it is not just R&I-specific legislation that has an impact on the EU’s competitiveness in this area. Instead, they suggested that all legislation needs to be considered, such as the impact of data protection regulations on the UK’s ability to access NHS patient data for medical research.

What next?

We are working with partners across Europe to engage with the EU directly, and also liaise with UK government departments to inform their input on the EU Council of Ministers to make sure EU legislation and initiatives benefit medical research in the UK and abroad.

In July we are holding a free workshop in Brussels with the Welcome Trust and European Foundations Centre to explore the proposed EU personal data Regulation and how it could impact of medical and social research. Email me if you want to register an interest in joining us. And in the Autumn, once details on the Horizon2020 programme are more clear, we will be running a workshop to help charities access European research funding.

NHS organisations use new health technologies as part of research programmes, but these technologies only become available to all patients as part of routine care if they pass a technology appraisal. NICE (National Institute for Health and Care Excellence) technology appraisals are the way that new technologies are assessed to see if they are both clinically and cost effective.

Funders need to:

• Ensure that the research they support will provide evidence that can be used in such an appraisal
• Ensure they can feed in the patient perspective of perceived benefits at the scoping phase of appraisals
• Look to the research recommendations and evidence gaps outlined in technology appraisals to inform their own strategic research funding decisions.

What is technology appraisal?

A new health technology is assessed over three stages to see whether it is clinically and cost effective for use in the NHS.

1. Scoping: defines why an appraisal in needed, which patient group, what comparator technology. Patient groups should be involved in this process, ensuring that the views of patients on the perceived benefits of a technology are taken into account.
2. Assessment: a systematic review of all research literature and a health economic assessment of the technology, carried out by an independent academic group. The assessment report on the strengths, weaknesses and gaps in the evidence. Charities can submit evidence to the appraisal, and will have funded the research that provides research evidence.
3. Appraisal: the appraisal committee considers the evidence and makes a decision, applying judgements on a range of factors. This is guidance issued by NICE to the NHS. Clinical commissioning groups, NHS England and local authorities (for public health) have to comply with NICE technology appraisal recommendations within three months unless there are significant barriers (ref: The National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013)

How does NICE judge that a technology is effective?

• It is clinically effective if, in normal clinical practice, it confers a health benefit, taking account of any harmful effects and opportunity costs.
• It is cost effective if its health benefits are greater than the opportunity costs of programmes displaced to fund the new technology, in the context of a fixed NHS budget.

What’s new in this guidance?

1. NICE has defined a reference case of methods to assess cost effectiveness. This will ensure consistency between appraisals and allow.
2. NICE has confirmed that it will include information from patients on the patient experience of living with the condition, having particular treatments, the outcomes that are important to patients, the acceptability of different treatments and patient perception of risk.
3. NICE has defined how these patient narrative summaries need to be provided, to ensure they can be incorporated into the systematic review.
4. NICE also wants patient groups to indicate if there are limitations to the current literature, or if inappropriate outcome measures have been used.

Patient groups can also comment on the relevance of outcome measures and economic evaluation tools outlined in the scoping document.

The report recommends the use of “safe havens” where data that could potentially identify patients should be handled, and that more should be done to make patients aware of how and why their data might be used for research.

Background

As part of the new information Strategy for the NHS, the government asked Dame Fiona Caldicott to review how we balance protecting personal health information with its sharing, including allowing researchers to access it to improve patient care. Dame Fiona recruited a panel to help her conduct this review including Sir Mark Walport, former-Director of the Wellcome Trust and Government Chief Scientist, and Jeremy Taylor, CEO of National Voices.

This previous blog gives more detail on why the review was set up and this lovely booklet gives lots of examples of why patient data is valuable to researchers.

What’s in the report?

You can read the full report here. Chapter 6 focuses on research, it makes two central recommendations:

• How to deal with data that has been stripped of personal identifiers but could potentially identify someone if linked to other key bits of information (data geeks know this as pseudonymised or key-coded). The review recommends that this type of data should be processed in well-governed, independently scrutinised and accredited environments called “accredited safe havens” and discusses the practicalities of how these would function.
• Consent for consent - where consent must be sought for a researcher to contact someone to ask for their consent to take part in research, creating a catch 22 situation. The Review Panel concludes that, wherever possible, privacy enhancing technologies should be used to minimise the need for access to identifiable information. For example, these would contact a GP if their patient was identified as being suitable to take part in a trial and ask the GP to approach the patient, meaning the researcher need not know the patient’s details. GPs already their patients consent to look at their health record. The CPRD takes this approach.

Chapter 5 (Information governance and the law) also makes a recommendation urging all organisations in the health and social care system to explain to patients and the public how the personal information they collect could be used in de-identified form for research and other purposes. The government has already made changes to the NHS Constitution to make this clearer for clinicians and the public – we are concerned that this is not enough by itself and our proposed new statement on patient data calls for the NHS to do more to talk to patients and the public about how they handle personal data.

The government has responded to the report

The Health Secretary, Jeremy Hunt responded to the report today, saying that  while effective sharing of patient information has enormous potential to improve patient care, services and treatments, this can only be done effectively if patients are given a say over how their personal information is used. He promised a  full government response in the summer, in the meantime he announced that:

• Any patient that does not want personal data held in their GP record to be shared with the Health and Social Care Information Centre will have their objection respected
• Where personal data has already been shared from a GP practice to the Information Centre, a patient will still be able to have the identifiable information removed

What next?

We are currently consulting on our new statement on the use of patient data for research, you can read our draft and have your say here.

The BMA, NHS England and the Royal College of GPs will be raising public awareness of how and why their data is used and how they can lodge an objection. GPs will also be contacted so that they understand the role they need to play.

Dame Fiona will now chair an independent panel to oversee and scrutinise implementation of the review’s recommendations and to provide advice on information governance issues.

This is very timely as government departments are in the midst of putting together their bids for government funds as the Treasury takes forward its latest spending round. The Treasury plans to announce their decisions on 26 June when we will find out  how much each government department will be getting and how this will be shared out across their spending responsibilities.

Some areas including health and education are protected and won’t be subject to cuts. But medical research charities alongside everyone funding research in the UK are particularly concerned about the decisions over the Department for Business, Innovation and Skills budgets which does not have its funding protected.

What does the report say?

Fuelling prosperity: Research and innovation as drivers of UK growth and competitiveness makes five recommendations to government to keep pace with our international competitors and ensure research in the UK can drive UK growth:

• Builds a stable ten year investment framework for research, innovation and  skills. This should sit at the heart of its emerging industrial strategy and plans for growth.
• Commits to increased investment in research and innovation to keep pace with other leading scientific nations.
• Secures the ringfencing of the science budget and continues to increase investment in research capital.
• Ensures that research continues to be at the heart of evidence based policy making across Whitehall.
• Creates a world class research and innovation environment that is attractive to talent, collaboration and investment from industry and from overseas.

The report itself puts together lots of great facts to demonstrate the value of research to the UK and our global standing. It compares how we are doing against our nearest competitors – pointing out that the UK’s public funding for R&D falls below that made by many of our global partners as a percentage of GDP (0.57% of GDP in the UK in 2011, in comparison to 0.85% in Germany, or 9.2% in the USA). This is the focus of the latest campaign by Science is Vital who are calling for the Government to increase research and development spending to at least 0.8 per cent of GDP – the G8 average – to enable us to compete more effectively with the leading economies of the world.

The report welcomes the UK Life Sciences strategy, touches on some of the innovative collaborations that UK funders are adopting to exploit new areas, and touches on new ways to measure research outcomes and inform future research strategies such as Researchfish who many AMRC members are beginning to work with.

The report also emphasises the importance of the UK’s diverse research base and the need to keep funding to maintain this and then goes on to outline its five recommendations to keep the UK a world leader in research.

What is AMRC doing to engage with the spending round?

We have been gathering evidence which we have been sharing with government departments, holding a series of workshops with BIS to better understand the interplay between public, charity and industry funders of research in the UK.

The APPG Medical Research is holding a breakfast in Parliament in May bringing Sir Paul Nurse - President of the Royal Society and Chief Executive of the new Francis Crick Institute, Harpal Kumar – chief executive of Cancer Research UK and Patrick Vallance - Senior Vice President of Drug Discovery at GlaxoSmithKline together to talk about the value of medical research to the UK’s future.

This spending round is for a relatively short term – we’re expecting a full-scale comprehensive spending review in the next Parliament – the next general election is due in May 2015. The current spending round is slightly smaller, reviewing the current spending allocations and agreeing budgets for 2015-16.

We are working with our members and government departments to gather information to inform this current spending round and for the longer term, looking ahead at what information would be helpful ahead of the comprehensive spending review. This includes working closely with MRC to better understand the impact of our funding and how this builds on and leverages other funders – as many of our members are now using Researchfish to capture the outcomes of the research they fund, this will allow us to better track and understand the impact our funding of research has in scientific discovery. We can then share this with our donors whose donations enable this, and the government.

The COMET initiative brings together people with expertise in a particular research area to collect evidence on what the core outcomes should be for clinical research in their field, and wants charities to contribute to those discussions

What are Core Outcome Sets?

Clinical trials aim to show that drugs, devices or therapies are effective. To do this, they need to measure effects (outcomes) in patients.

These might be something physiological, like blood pressure or levels of a particular hormone or chemical in the blood, or participants could fill in a survey about their experience, like their pain levels.

A “Core Outcome Set” (COS) is an agreed set of what should be measured and reported in all trials in a specific disease or condition area. This allows researchers and regulators to compare the results of different trials.

Who should decide what is a common outcome measure?

Standardising these measurements across the research community is a huge task requiring input from a range of stakeholders. The COMET initiative  has built up a database of studies relating to defining what should be considered core outcomes, and from this, is developing the sets of agreed measurements for all trials in a particular area of research.

To ensure the right measures are chosen, the entire research community, including patients and clinicians has to feed into this development.

COMET is keen to hear from a range of stakeholders including charity research funders and patient groups.

AMRC member charities can bring detailed expert knowledge of their research area, and are uniquely placed to bring knowledge of what healthcare outcomes really matter to patients, and so ensure that this knowledge is built into guidelines for researchers.

How charities can get involved

• Research staff can promote the relevant COMET data set in information to applicants and if possible, include a requirement to consider them in terms and conditions. The COMET outcomes are recognised by NICE in their sources for setting clinical guidelines, and so aligning your charity’s research with these will help simplify process of getting new treatments approved for use in patients in the NHS.
•  Work with COMET to develop outcome sets. You can attend their conference in Manchester on 20-21 July  to learn more about Core Outcome Sets and meet other stakeholders and researchers working in this area.
•  Fund research to develop new Core Outcome Sets. The initiative is looking to list charities with an interest in this area, so that COS developers seeking partners and funders will be able to easily find charities that might be willing to help them. Contact COMET to get involved.

From this, we have now developed a draft statement and supporting briefing. We need you to tell us whether we have struck the right balance between protecting individual patients’ rights and enabling research to go ahead. Have we got the right calls, or are there other actions we should be calling for? We are making our draft statement public for you to take a look and feed back.

Please get back to me with your thoughts by 31 May 2013.

Download our draft AMRC statement on access to patient data for research for consultation.

What are we proposing to say in our statement?

Patient records are a valuable resource for health research. Access to the data in these records helps researchers better understand disease and develop treatments that can save lives.

Regulations governing use of these data in the past have been ambiguous and as a result it can be difficult for researchers to use them. We believe that it is possible to encourage the safe and secure sharing of these data to facilitate research whilst protecting patient confidentiality. This needs a simpler and more agile regulatory framework, a concerted effort to publicise the important role patient data plays in research and better systems and infrastructure that encourage data sharing whilst preserving their security.

Our Summary Statement

1. Patient data is valuable

Researchers have made life saving advances using patient data and patients want their data to be used.

• Researchers use patient data to better understand trends in conditions and the outcome of treatments, for example identifying the link between smoking and lung cancer. And access to data allows researchers to identify patients to invite to take part in trials of new drugs. Trials which we know people want opportunities to be involved in – 72 per cent of 1000 adults surveyed in 2011 would like to take part in research trials.

2. Protecting confidentiality

We can access patient data in a way that both respects people’s rights and allows us to conduct publicly valuable research.

• We believe that all anonymised patient data should be made freely available to researchers and that key coded data (so called pseudonymised) should also be similarly available to researchers provided that the key that breaks the code is held separately and securely.
• Identifiable data should only be accessed with consent from the individual involved. Where research is very important and it is not practical or possible to get consent from everyone, we believe the Health Research Authority (HRA) can regulate access to identifiable data effectively but is must explain clearly to the public how it will do this so that people have confidence in research processes.
• Data sharing technologies and the governing regulations need to keep pace with technological advance so people can continue to feel their confidentiality is protected.

3. Public understanding and choice

It is important that people can understand how their data is used and their confidentiality protected. We need:

• The NHS to publicise the NHS Constitution and develop supporting information to clearly explain how people’s data will be handled and each person’s rights.
• NHS staff to be given information and training to understand the guidelines around the use of patient data and their responsibilities.
• Tailored resources to help answer patient’s questions available on NHS websites including NHS Choices and the UK Clinical Trials Gateway; for example the UK Clinical Research Collaboration leaflet Health records save lives should be distributed more widely in GP’s surgeries and pharmacists.

A better system is needed that encourages patients to be involved in research and allows them to choose how they would like to be. We need:

• Patients to be approached to take part in research by trusted individuals, usually their GPs, who can provide further information and answer their questions. This information could be collated on the UK Clinical Trials Gateway.
• Opportunities for people to self-refer their interest in taking part in research without contacting their GP. Information on how to do this should be linked with the UK Clinical Trials Gateway.

4. Improving the system

We need better systems and infrastructure that encourage data sharing whilst preserving their security

We need a simpler regulatory framework:

• Focusing Caldicott Guardians on facilitating the delivery of research studies that have gained approval to use data, rather than being involved in the approval process.
• The UK government to engage with Europe as data protection legislation is updated to ensure this supports safe and secure access to patient data for research.

We need standardised models for gathering and sharing data. We need:

• Health Education England to equip NHS staff with the skills to handle and use data.
• NHS England to promote best practice in the handling, use and sharing of data by Clinical Commissioning Groups and the providers they commission services from.
• GPs to be required to share their data with the Clinical Practice Research Datalink (CPRD).
• The Clinical Practice Research Datalink (CPRD) to be extended UK-wide and to link with other datasets so researchers can safely access the data contained within them.
• The NHS to work closely with the many disease-specific registries that already exist to ensure researchers can access this data, including those developed for example by disease-focused charities.

You can download the full draft statement as a pdf here here.

What next?

We’d like to know your thoughts by 31 May 2013, please email them to me at b.purvis@amrc.org.uk. We will then use your comments to produce the final statement.

Fiona Caldicott has been conducting a review of the balance between protecting patient information and its sharing, to improve patient care. AMRC gave evidence to this review and it is expected to report shortly – including making some recommendations for how individual’s patient data should be handled for research.