AstraZeneca to run more clinical trials in people’s homes to improve diversity
AstraZeneca is to let more people take part in clinical trials from the comfort of their own homes in an attempt to increase the diversity of participants.
Recruiting volunteers to clinical trials can be difficult, but they are a crucial step in the development of new drugs, tests, devices and other interventions.
Concerns have been raised that a lack of diversity among people participating in clinical trials means drugs and medical equipment may be less effective in certain groups.
The health secretary, Sajid Javid, on Sunday announced a review into systemic racism and bias in medical devices to examine why people of colour and women have worse health outcomes.
Cristina Durán, the chief digital health officer, R&D, at AstraZeneca told the Guardian typically only 3% to 5% of eligible patients choose to join a clinical trial, with recruitment taking as long as 18 months.
Experts have stressed it is crucial there is diversity among trial participants, as genetic, social, and cultural factors can all affect the way different groups respond to interventions.
Early trials of Covid vaccines were criticised for predominately involving white participants, despite the virus having a disproportionate effect on people of colour. A lack of diversity in clinical trials has also been cited by the nonprofit organisation breastcancer.org as one of the potential reasons Black women in the US have worse breast cancer outcomes than other groups.
Now experts at AstraZeneca have said shifting data collection to the home may break down barriers to participation in clinical trials, potentially increasing diversity and the speed of research.
Durán said before the pandemic the company had sought to delve into the issue of recruitment, by carrying out interviews with patients.
“The feedback was mainly that it was very burdensome for patients to participate, because it did require for them to travel to a hospital or site, to spend quite a significant number of hours at that site, either waiting or having the procedures done to collect the data,” said Durán, adding historically about 90% of such data was collected at such locations.
Durán said the team found participation could be made far more accessible. “We reviewed close to 100 protocols – those are the instructions of how to run clinical trials – and 70% of that data could be collected[…] at home.”
Heart rate and activity are among metrics that can be monitored at home and it is also possible to take blood samples and evaluate lung function.
Durán said while it was feasible to collect some of the data at home before the Covid pandemic, the crisis had accelerated the approach.
“All the technology was there, but what we’ve seen through the pandemic is a change of behaviour,” she said, with many people having to interact with healthcare in a different way, for example through telemedicine calls with doctors.
Phillippa Brown, vice-president of development operations, R&D, at AstraZeneca said that among other approaches to increase participation of minority populations, the company has been increasing the diversity of investigators on clinical trials – a move she suggested could help to build trust with local communities.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine said “increasing diversity in trials is something that virtually every trialist wants to do”.
But doing some things from home could come with downsides. “People may not make the measurements as carefully as they are made in a clinic,” he said, adding it was also extremely important participants were unaware of the treatment they have been given – for example whether it was an active drug or a control. “Otherwise the biases could become very substantial,” he said.