International Clinical Trials Day - how is COVID-19 affecting research?

On International Clinical Trials Day, Dr Sheuli Porkess considers the impact that COVID-19 is having on clinical trials and the potential lessons for the future research.

Today is International Clinical Trials Day, when we celebrate the day in 1747 when James Lind started what is widely considered to be the first randomized clinical trial, with a ‘fair test’ of treatments for scurvy in sailors.

Ever since then, clinical trials have been essential for new treatments, vaccines and medicines, and never have they been more vital than now during a pandemic.

Current situation

There are more than 1500 commercial clinical trials of medicines to prevent or treat COVID-19 underway around the world – a figure which will be out of date very quickly in this fast moving situation.

The UK Government and research authorities in the UK have brought in new processes to support and prioritise COVID-19 clinical trials. By triaging between Government, funders and regulators, a range of studies have been set-up in a speedy and efficient manner, with hugely successful patient recruitment. The results of these trials will be essential to our understanding of what could work to help treat COVID-19.

COVID-19 impact on clinical trials

COVID-19 has brought about both negative and positive changes to clinical trials.

The process of prioritising COVID related trials helps to avoid duplicative research efforts, supports scientists in learning as much as possible about this disease and ensures research staff are redeployed where needed – on the frontline or on urgent COVID-19 research.

The knock-on effect is that some valuable non-COVID research has been halted.

The decision to halt a clinical trial is not one that is taken lightly and companies are doing everything they can to keep non-COVID trials going wherever possible, with patient safety the top priority.

We know that companies have introduced measures like direct to patient shipments of investigational medicinal products; supporting investigator led home or local laboratory study assessments and administration of treatment; and doing remote follow up and monitoring of study patients via video or telephone.

All these changes are positive measures that reduce unnecessary trips to hospital, making trials far more convenient for people who are giving their time and energy to participate in a trial.

Despite these adaptations, not all trials have been able to continue. Looking at charity-funded studies, the Association of Medical Research Charities says that more than half of their members have had to stop, pause or delay most of their clinical trials as a result of COVID-19, and say they are at risk of not being able to restart them. AMRC estimates 126,000 patients are affected.

Lessons going forward

We need to get the UK research ecosystem back up and running as quickly as possible, for the benefit of people and families who are affected by non-COVID related conditions every day.

Looking forward, the UK Government must not only support academic, charity, SME and pharma in resuming research that was paused during the COVID-19 pandemic, but also ensure new research can be set-up and delivered – restoring the UK’s world-leading research base. This however must be done with consideration of NHS capacity and the need to continue providing critical frontline care to patients.

There are lessons for researchers too. The UK has demonstrated that research can be funded, designed, set-up and delivered in a fast and efficient manner, so looking forward we need to assess which of these changes in ways of working can be adopted long-term. COVID-19 has also emphasised the fact that conducting research in diverse populations is crucial and we need to make sure we include this in other research.

The success of any research is dependent on making it relevant. This requires involving patients and the public in how we design and communicate our research and COVID-19 research is no exception. (Many thanks to the Academy of Medical Sciences for their recent event on this topic) 

As and when we can, we must learn any lessons from COVID-19 for research, to maximise our chances of developing the new medicines for the future across all diseases and for all groups of patients.