Adapting clinical trials during the pandemic

When the COVID pandemic began in the UK in March 2020, many non-COVID clinical studies were put on hold. It quickly became clear that to restart research, adaptations would need to be made to ensure that studies could resume in a way that was safe for all involved.

Now almost a year on, it is clear that these adaptations are not temporary. The way we do research has changed for good. The challenge remains for researchers to adapt studies from the traditional face-to-face-only approach and make research participation more flexible, convenient and, importantly, safe for people as the pandemic continues.

At Parkinson’s UK, we know that people affected by Parkinson’s have a vital role to play in helping researchers figure out what clinical trials should look like moving forward. We’ve been supporting research teams to understand what people affected by Parkinson’s want from research during this time, and how studies can be adapted to make participation safe and convenient.

Perceptions of research participation

Parkinson’s UK is funding a world first clinical trial at King’s College London (KCL), which will test whether cannabidiol (CBD) is safe and effective for treating Parkinson’s psychosis symptoms.

The trial, led by Professor Sagnik Bhattacharyya and Dr Latha Velayudhan at KCL, was due to open for recruitment in Spring 2020. However, this had to be delayed due to the COVID-19 pandemic.

The research team began to explore how the trial could be adapted so that it could be made safe for the trial to start amid the pandemic. They had some ideas, but knew that it was vital to seek the views of people affected by Parkinson’s to understand the best way to adapt the trial.

The team worked with Parkinson’s UK and 3 patient and public involvement (PPI) volunteers to design a survey to explore people’s perceptions of taking part in research in light of the COVID-19 pandemic. Additionally, they sought the views of people affected by Parkinson’s on how the trial could be adapted to make it safe and convenient for people to take part.

The results of the survey revealed enthusiasm for participating in research during COVID-19, so long as appropriate safety measures were put in place. Most people felt that replacing some face-to-face visits with virtual assessments was a good idea, though they noted the importance of providing clear information and instructions. 

Emotional support was highlighted as crucial for this trial, given the types of symptoms that participants will be discussing. People also noted that measures such as requiring participants to wear personal protective equipment may bring about particular challenges for people experiencing psychosis.

It is important that appropriate support is in place throughout the trial to ensure participation can be made as comfortable as possible.

Getting research up and running again

Another research team funded by Parkinson’s UK were also quick to work with people affected by Parkinson’s to make study adaptations.

Professor Suzanne Reeves is leading the Parkinson’s UK-funded TOP HAT trial, which is testing whether the anti-sickness medication ondansetron can effectively treat visual hallucinations in people with Parkinson’s.

The team received ethical approval for the trial in March 2020, but very quickly had to think about how they could adapt the protocol to comply with COVID-19 guidelines and minimise risk for all involved.

Suzanne invited people affected by Parkinson’s to an online focus group to get their thoughts on some of the changes the team were considering, and to discuss ways of making the trial assessments more remote in order to comply with COVID-19 guidelines.

Together with people affected by Parkinson’s the team made a number of changes to the protocol, including:

• limiting face-to-face visits, and instead giving people the option of either video or telephone consultations
• using a modified version of the UPDRS part 3, which assesses motor symptoms, requiring no physical contact
• arranging for the drug being tested to be delivered directly to people’s homes, rather than people having to pick it up from a pharmacy
• collecting data from participants and clinicians on the satisfaction of video consultations, to inform future studies.

As a result of these changes, the first participant was able to be recruited into the study in January 2021.

Gathering views from the wider community

Many Parkinson’s researchers were in a similar position to Sagnik and Suzanne, and were beginning to make changes to their studies to enable them to begin again.

While it was good to see researchers adapting quickly, we recognised the need to explore what implications these changes could have on people affected by Parkinson’s. Crucially, we also needed to understand how people affected by Parkinson’s felt about taking part in research during the pandemic, and hear what things they needed to feel safe, supported and confident to take part in research.

Building on the survey we developed with Sagnik and his team we were able to gather views from 548 people affected by Parkinson’s. We found:

• 91% of people said they would be happy to still take part in research during the COVID pandemic
• where face-to-face visits are required, people would prefer home visits as an alternative to visiting a study centre or hospital
• 94% of people said they would be happy to carry out study assessments at home
• the majority of people did not yet have experience of taking part in a video consultation as part of a research study or their healthcare.

We then worked with a group of patient and public involvement volunteers to develop recommendations for those involved in the design and delivery of research to help them think about what to consider when adapting studies for people affected by Parkinson’s.

Read our report "Driving research forward during Covid-19" (PDF, 664KB).

Continuing to shape research together

The COVID pandemic continues to provide challenges for researchers planning and carrying out clinical trials and we know that working together is key to overcoming these. People affected by Parkinson’s have already provided important insights on adapting clinical trials, and we must continue to build on these. 

Seeking feedback from people taking part in trials is crucial as we look to learn what works well, and what doesn’t. It is important that researchers build feedback into their research plans, and that they continue to work with people affected by Parkinson’s to evaluate this feedback to help ensure that future trials meet the needs of those taking part.

The pandemic has changed the way research is done. By uniting researchers and people affected by Parkinson’s, we’re helping ensure that this change brings us closer to new treatments and a cure for Parkinson’s.

More information for researchers

Get advice and guidance on how you can involve people affected by Parkinson’s in your research.