Rising to the challenge: managing clinical trials during a pandemic

20th May 2021

Clinical trials are vital in making research breakthroughs possible. At the Quadram Institute, hundreds of people each year participate in our trials to be part of scientific research. But what happens when a pandemic causes a worldwide disruption?

International Clinical Trials Day is a celebration of James Lind’s very first clinical trial, and the day commends the importance of clinical research. To mark International Clinical Trials Day 2021, researchers across the Quadram, Norfolk and Norwich University Hospital (NNUH), and Norwich Research Park reflect on their experiences managing clinical trials during a pandemic.

Discover how researchers and participants are supporting making a new COVID-19 vaccine a reality, tracking the virus in the gut, embracing remote practices, and pivoting their research to offset the challenges of the pandemic.

 

Making a COVID-19 vaccine a reality

Although studies in other therapeutic areas were unavoidably constrained, the NNUH Research teams helped make a new COVID-19 vaccine a reality.

The Quadram Institute is home to the NNUH-run Clinical Research Facility. Providing a mixture of outpatient clinic and laboratory space and a food-preparation area for diet-related studies, the CRF is one of 35 clinical research facilities nationally and an integral part of research in the region. It was here that the team delivered a Phase 3 COVID-19 vaccine trial, ‘Novavax’.

The Novavax study was the largest double-blind, placebo-controlled COVID-19 vaccine trial to be undertaken in the UK so far. It also reflected an incredible milestone for the staff at CRF and NNUH due to the recruitment size (500 participants), extraordinary speed of execution in setting up the trial (30 days), and the size of the research team involved (up to 60 staff, including staff from the James Paget University Hospital and NIHR Clinical Research Network Eastern). As Felicia Rowe, CRF Operations Manager, reflects:

The NHS Clinical Research Facility at Quadram Institute was instrumental to supporting the important national research to find an effective vaccine for COVID-19. The whole of NNUH’s Research Department – up to 60 staff, including research nurses, practitioners and administrators, plus staff from James Paget University Hospital and NIHR Clinical Research Network Eastern – have been diverted to work on the Novavax vaccine trial whilst continuing to run their research portfolios. Our team has shown tenacity, flexibility and sheer determination to deliver whilst caring for the trial participants and ensuring a positive experience. We are delighted to be able to host such a momentous study, the first of its kind in Norfolk.

The Covid-19 vaccination research team outside the NNUH-run Clinical Research Facility. Image: NNUH

 

Tracking the virus in the gut

Studies into SARS-CoV-2 have reported that over 60 per cent of COVID-19 positive subjects show gastrointestinal symptoms, and furthermore that the virus has been identified in the stools of some sufferers.

Researchers at the Quadram Institute are collaborating with colleagues at the James Paget University Hospital and the Norfolk & Norwich University Hospital in order to better understand the link between SARS-CoV-2 and gastrointestinal symptoms, in a Norfolk-based study called the ‘CoPS study’.

We have been really impressed with the desire of COVID-19 positive residents of Norfolk to help in this study during such difficult times, and cannot thank them enough. With a little more help we hope to gain a greater understanding of the colonisation of the virus in the gastrointestinal tract, and to assess the risk of virus transmission via the faecal-oral route. Dr Lee Kellingray, CoPs Study Lead

If you are over the age of 18, live within a 40-mile radius of Norwich and have been tested positive for COVID-19 within the last 2 weeks, you could help support our researchers and the CoPs study. Find out how here.

 

Embracing remote practices

The continuance of clinical trials was hurled into a state of uncertainty by the COVID-19 pandemic. By harnessing digital innovations, researchers achieved the ‘impossible’:

Delivering a clinical study at a time when we were all asked to stay at home initially seemed impossible, but dogged determination and a collaborative effort from scientists, medics, nurses and clinical research staff at the Quadram Clinical Research facility allowed us to do the impossible. We re-invented our entire DIME (Dietary BIoactives and Microbiome DivErsity) study protocol to allow fully remote, contact-free interactions between participants and researchers, maintaining safety, following guidance and collecting good data. This was indeed a team effort. We could not have achieved any of this without the motivation of all parties. Kathryn Murray, DIME Study Lead

Embracing remote practices and digital technologies meant increased benefits for both researchers and participants, as Dr Lindsay Hall and Sarah Phillips discovered:

The PEARL study is recruiting 250 healthy pregnant women to help us understand how gut microbes contribute to maintaining health during pregnancy and early life. Participants are enrolled on the study before 22 weeks gestation and remain a part of the study until their infant is two years old.

With their help, we hope to answer questions such as; how do microbes change during pregnancy, how do these microbes pass onto the infant, how do various factors, such as diet/ antibiotics, influence microbial communities.

Running a clinical study is always full of surprises; a global pandemic has been the most recent in the running of the PEARL study. With the coming of COVID-19, there has also been a new wave of innovations for local practices in delivering clinical studies. For the PEARL study, we have been able to develop a remote/digital recruitment process. This is not only safer during the pandemic, but also much more convenient for our participants.

More information about this study can be found on our webpage here.

The GlyCarb Remote study is investigating how different carbohydrate-rich meals affect blood sugar levels. The team also embraced remote practices, and participants could get involved in the study from home with the “virtual” support of the study research team. As Dr Cathrina Edwards and Marina Corrado found, the participants have shown an increased ownership and engagement with the research:

The biggest challenge that we faced last year was not being able to meet our study participants face-to-face. This year we decided to change the way we run clinical trials to go completely remote. Running a trial away from a clinical facility will be challenging for the research team but it is a great opportunity for participants to get involved with the research from the comfort of their own home, and to take ownership of the research and to be in control of each task performed with remote support from the research team.

Now more than ever, the success of a remote study belongs to participants as much as to researchers.

 

Pivoting Research

The sensitive nature of clinical health trials means that researchers often work with the most vulnerable in society. Katharine Seton pivoted her research to ensure the continuation of the ME/CFS study:

The pandemic posed a number of challenges for our human study “Defining autoimmune aspects of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)”. Our patients are severely ill and therefore were shielding from COVID during the pandemic. This meant that we were unable to undertake home visits for sample collections, and so instead, we have focussed on analysing samples donated prior to the pandemic.

Working with researchers from the University of East Anglia, Norwich and Norfolk University Hospital and NRP Biorepository, Nancy Teng is leading the BEAM study into the gut microbiome and breast cancer. The disruptions of the pandemic meant Nancy had to replan the trial to ensure it went ahead safely:

 Being involved in planning out a trial is daunting but exciting. You try to cover all your bases and foresee any potential issues. Unfortunately, a pandemic wasn’t on the “potential issue” list. Replanning the trial to make it run in a COVID-19 setting was possible by the ingenuity and perseverance of researchers and staff members across the NNUH and NRP.

The BEAM research team are recruiting participants who have recently been diagnosed with breast cancer to donate their tissue for research. Read more here.

 

Extraordinary measures in extraordinary times

These extraordinary measures reflect these extraordinary times. Our researchers and participants’ continued perseverance and resilience reflect the remarkable scientific research taking place at the Quadram and in Norwich. The challenges and disruption of the COVID-19 pandemic are still impacting current and future clinical trials, as Dr Antonietta Hayhoe, our Human Study Lead explains:

This is a unique time for Clinical Research around the world. The COVID-19 pandemic has had, and is still having, an impact on both the delivery of current trials and the starting of new trials. At the Quadram Institute, we have explored new ways to manage clinical trial challenges during the pandemic. We are regularly taking actions to respond to these challenges and to protect the rights, safety, and wellbeing of our research participants and all those involved in our clinical trials. An important lesson in Clinical Research has been learned during this time!