Publicly funded research aims to benefit patients and the best way to make sure it does is for researchers and funders to partner with patients. This will ensure research prioritises what matters to patients. It will lead to more effective research. And it will help ensure that research delivers benefits for patients rather than simply “success” for researchers. Two studies underway showcase this approach, which should become the “new normal”.

Why do charities and (via the Government) taxpayers fund medical research? Simple: to deliver real benefits for sick people. Since it’s all about benefitting patients, the current practice of shutting them out of the research process makes no sense.

We still don’t know what causes ME/CFS and have no effective treatments for it. We need a better approach to research and we need patients to be at the heart of things.

Researchers, funders and patients should now come together and work in partnership. There are three reasons why this approach should lead to faster research progress.

1. It will focus research on the priorities that matter most to patients.
2. It will make research more efficient and effective.
3. It will help ensure that research is delivering progress for patients and not simply “success” for researchers.

Here is how patient involvement in research will deliver each of these improvements.

1. Focusing on the patients’ priorities

People living with Long Covid (who are experts by experience) should be equal partners in setting the research agenda.

The National Institute of Health Research

Research is supposed to deliver benefits for patients, so why not ask them what benefits they want? What research questions do patients want answered?

In the UK, the James Lind Alliance is already doing just this through priority-setting partnerships. It brings together healthcare professionals and people living with an illness to agree on the most important research questions.

For many illnesses, not just for ME/CFS, these are not always the priorities that funders and researchers have chosen to pursue.

Once the new priorities have been agreed, the next step is for patients and health professionals to sit down with researchers and discuss a programme that delivers on these.

This new approach is now being applied to ME/CFS through the Prioritise ME initiative, led by Sonya Chowdhury, CEO of the charity Action for ME. It is supported by the UK’s two main public funders of medical research – the Medical Research Council and the National Institute for Health Research (NIHR).

Chowdhury said, “Priority Setting Partnerships for other illnesses have led to more funding, more research and better treatments. We desperately need the same level of transformation for ME/CFS and will work in partnership with funders, people living with ME/CFS and clinicians to deliver real benefits for patients.”

It will be critical that researchers and funders do partner with patients and clinicians to agree new research priorities.

(You can submit your own research priorities for ME/CFS using this survey.)

2. Involvement making research studies better

The Medical Research Council and, particularly, the NIHR are asking researchers to engage with patients and the public in their studies.

Researchers can do this by informally consulting patients or even by having an advisory panel of patients.

For a treatment study, for example, this approach could involve patients advising on how to measure treatment success.

For ME/CFS, this might mean rejecting questionnaire scores as a measure of success, and instead using objective measures of whether patients can do more physically or have managed to increase their hours of work or education. These are outcomes that make a real difference to patients’ lives.

Patients as partners

But the most radical way for researchers to engage with patients is to invite them onto the research team.

That’s exactly the pioneering approach taken by the DecodeME study. It is a very large DNA study that is looking for biological causes of ME/CFS.

Most of its research investigators are professional scientists. But joining them are Andy Devereux-Cooke, a patient and founder of the forum Science for ME, and Sonya Chowdhury. She is both a carer for her son who has ME, as well as the CEO of Action for ME.

The study’s management group consists of Professor Chris Ponting, the lead scientist, together with Devereux-Cooke and Chowdhury. People who live with ME are literally leading the study.

Patients, carers and charities are also helping deliver every aspect of the study, as well as forming an overall steering group.

People with the illness are the true ME experts. As a scientist, it is hugely valuable to be able to consult regularly with them as colleagues.

Professor Chris Ponting

Our views are taken as absolutely equal to the scientists involved.

Sian Leary, DecodeME team member with ME/CFS

How partnering with patients helps research

DecodeME needs to recruit 20,000 participants, which is a huge challenge, particularly for a relatively rare disease.

Patients have been consulted about DecodeME from the start so it is not surprising that they have enthusiastically spread the word about joining. Patients are also helping to produce recruitment material, making sure it’s relevant to patients like themselves.

This approach is directly benefiting the study. So far, well over 20,000 people have registered an interest in taking part and the study doesn’t even launch until September.

Truly informed consent

Researchers must make sure that everyone who wants to take part in a study understands what it involves, so that patients can give properly informed consent.

However, scientists don’t always find it easy to explain the science to lay people, or to guess what issues patients might want to consider.

DecodeME has taken a novel approach, led by patients on its team who said the explanation and consent form drafted by the scientists wasn’t right for patients.

Scientists and patients worked together to produce material that clearly explained the science and the issues. They also agreed that some things the scientists wanted, such as consent for access to information from medical records, should be optional for patients, not compulsory.

The new material was tested on a sample of potential participants, and all said they understood what was being asked of them.

Almost everyone also said they would be happy to give consent. Typically, around a quarter of people decide not to give consent in studies comparable with DecodeME. High consent rates for DecodeME will make it easier for to reach its extremely challenging target of 20,000 participants.

3. Focusing on true success

For patients, research success is simply getting a better understanding of the disease, and progress towards effective treatments.

That’s not how success is defined for researchers.

Much as researchers want to make breakthroughs and help patients, their profession rewards them for publishing studies that are quoted by other researchers and winning funding for their research. They are not specifically rewarded for benefitting patients.

Researchers’ career progression – and often their very jobs – depend on these academic measures of success, and so that is what researchers will inevitably focus on.

Many people with ME/CFS would argue that not focusing on delivering for patients has been a major problem in the UK.

A great deal of money and effort has gone into researching biopsychosocial explanations and treatments for ME/CFS. These approaches have been popular among funders and many researchers, delivering “success” in the form of publications and grants.

Yet they have consistently failed to deliver for patients. NICE recently graded all the research for psychosocial treatments of ME/CFS as being of low or very low quality. And it is poised to issue guidelines warning against using any of these treatments.

For years, patients – endorsed by many scientists – have warned researchers and funders about the deep flaws in the science of these treatment trials, the lack of treatment benefits, and the evidence of harm.

Sadly, researchers and funders refused to listen, criticising patients for raising their concerns. As a result, millions of pounds and many years have ben wasted, with patients as the losers.

We need a new approach.

Partnership is the way forward

We deserve better than this, and DecodeME is an example of how patients, researchers and funders can start creating a way forward, together as equals.

Andy Devereux-Cooke, DecodeME co-investigator

We need the approach pioneered by DecodeME and Prioritse ME to be the future, not an exception.

It is time for researchers and funders to partner with patients and agree a research agenda. It is time for researchers to partner with patients as the new normal to carry out better research.

And it is time to ensure that public funds spent on research deliver for people with ME/CFS.

Let’s all work together to make this happen.