‘Project restart’: putting patients and the public at the heart of research resumption By Dr Natasha Ratcliffe, Research Involvement Manager, Parkinson's UK Published: 26 May 2020 The coronavirus pandemic has had a major impact on research activities across the UK, and beyond. Perhaps most obviously, research priorities immediately shifted to focus on COVID-19 studies, as research was declared a key part of the government’s response to the pandemic. But alongside this, the pandemic meant that many ongoing research studies had to be paused. Staff involved in research delivery returned to frontline services, and lockdown restrictions meant that it was simply not possible for clinical studies to continue. Many research studies were therefore put on hold, with a cloud of uncertainty over when and how they might resume again. Now, at the end of May 2020, the lockdown restrictions are beginning to lift and we are all having to reimagine what our daily lives will look like over the coming months. And importantly, research is starting to do the same. Thoughts are turning towards how we restart non-COVID-19 research in the UK in a way that is safe for all involved. Working together to adapt Resuming research is vital. Parkinson’s hasn’t stopped during this pandemic, and the same goes for all other health conditions. And so the search for better treatments and cures must continue. In addition, for some people the pause of research studies has had a significant detrimental effect on their health and care. It’s therefore crucial that these studies begin again as soon as possible. On 21 May, the NIHR set out a Restart Framework outlining plans for restarting NIHR research activities which have been paused due to COVID-19, and many other funders, institutions and organisations will be doing the same. Researchers and companies are starting to think about what adaptations they will need to make in order to ensure their studies can resume as soon as possible. Trial protocols will need to be reviewed and adapted to take account of government guidelines and new safety measures. COVID-19 has seen a massive shift in the way people access clinical and research services, with remote consultations becoming a necessary part of the process. Some researchers and companies were already considering how they could make use of remote consultations in trials and exploring the idea of virtual trials, but the pandemic has meant these plans have been fast-tracked from ideas to reality in a very short space of time. Reducing study visits and making use of remote assessments in trials are things that all researchers are now having to consider — although these of course will not suit every trial. However these discussions go, it is absolutely vital that adaptations and changes to trial protocols happen in consultation with patients and the public. Too often, in the haste of getting research (re)started, patients and the public are overlooked as a key voice in decision-making processes — we saw this at the beginning of the pandemic, when many COVID-19 research studies began without any patient and public involvement plans and there was a substantial drop in involvement rates. A stark reminder that we are still some way off patient and public involvement being embedded as a standard part of the research process. Patients and the public have a vital role to play in helping researchers figure out what clinical trials should look like moving forward, in light of COVID-19 — as pointed out in the guiding principles of the NIHR Restart Framework (number 5). It’s easy to make assumptions about what research participants might want from trials in this new era of research. But the only way you can get a good idea of what is going to work for participants is by speaking to them, or other patients and members of the public in a similar position. Protocol amendments should not be made without the consultation of patients and the public, in order to ensure that the changes suggested are appropriate and consider a diverse range of circumstances. Patient and public involvement must play a key role in ‘project restart’, for all researchers and companies. Now is a key time for clinical trial investigators and researchers to be reaching out to patients and the public to discuss what their research should look like when it resumes. Some researchers are already working closely with patients and the public to address the key questions that are arising in relation to the restart, which is great. But in the haste to get things resumed, the reality is that many researchers — even those with strong links to public contributors already — will simply forget that they should be discussing these topics with patients and the public. Help is at hand The good news for researchers is that there are lots of organisations across the UK who can help connect you with patients and the public to discuss how your research restarts. At Parkinson’s UK, our Research Involvement team provides hands on support for research teams and companies to connect with people affected by Parkinson’s through our patient and public involvement programme. We can also provide hands-on support to carry out activities such as online focus groups and remote consultations. We’ve been supporting researchers to carry out remote patient and public involvement activities for a number of years now, and remain committed to supporting this during the pandemic — find out more about our support during lockdown and beyond. Many other charities have similar programmes of support — the Charities Research Involvement Group all support the active involvement of patients and carers in research. You can find a list of the charities involved here. The NIHR Research Design Service also offers patient and public involvement support for researchers. Find out more about how the RDS is supporting researchers here. So researchers — as you begin planning what your studies will look like when they resume, make sure you reach out and work with patients and the public to help you. Working together is key to successful research.