Senior Director Digital Strategy & Solutions,
Labcorp Drug Development
Director Patient Recruitment & Engagement,
Labcorp Drug Development
Digital technology is leading to broader diversity in recruitment for clinical trials and enabling patients to have a stronger voice in design of modern medical studies.
With a growing recognition that patients have a pivotal role to play in the design and development of clinical trials, specialists who recruit to trials also point to the value of digital technology in helping create a diverse, relevant and representative patient group that is able to actively participate.
Increasingly, that participation is conducted remotely – reducing the need for participants to attend hospitals, clinics or trial centres – with data captured and transmitted from a home environment in real-time to the study team or by conducting televisits with the hospital staff.
The ripple effect
With disparities in ethnicity, low socioeconomic background, age, geographical location, cognitive impairment, and with patients who are transient or have religious or educational needs, assembling the right patient group is critical.
“All of these have to be taken into account when we design a protocol that works for the patient population,” explains Melissa Harris, who recruits patients for trials for the pharmaceutical industry.
“But there is also a significant ripple effect. If there is a lack of evidence to support that these trials have been done in the right populations, doctors might be reluctant to prescribe. That means we would let down an entire community of patients for generations to come.
“We have to know how these new drugs work in different patient groups, so it is critical that we get the right patients into the trial.”
Patients are recruited to clinical trials via electronic health records, from referring hospitals and specialist centres, social media and traditional advertising and patient advocacy groups.
Harris is Director in the Patient Recruitment and Engagement Team at Labcorp Drug Development, a clinical research organisation, which runs studies for pharmaceutical companies. Her focus is on ensuring that patients on clinical trials receive the education and support that they need to take part.
“We do that through our Voice of the Patient programme; listening to our diverse sets of patients in order that we can truly drive inclusive trial designs,” she explains.
So, why is it important that the patient voice is heard? “If you do not include the ‘voice of the patient’, you end up with a trial design that is not liveable – it needs to be a trial that patients want to and can take part in. We have to make sure that we are listening to the patient population who live with that condition to meet their needs.”
If you do not include the ‘voice of the patient’, you end up with a trial design that is not liveable.
Clare Campbell, a Senior Director for Digital Strategy and Solutions at Labcorp, says patients are increasingly more informed in their understanding and knowledge of clinical trials, but fewer patients are joining them.
“It is our job to reach out to diverse patient populations to help them understand that clinical trials might be a powerful option for their care,” she says.
This is assisted by technologies that can allow patients from different backgrounds to access oncology trials, whilst reducing the burden of trial participation on them and their caregivers.
Technology gained wider acceptance among patients during the COVID-19 pandemic, but it has also catalysed increased inclusivity and broadened the diversity of patients, as well as helping researchers provide greater equity of access to trials.
Campbell says digital solutions also help to increase data quality – for example wearable devices that can record and transmit biometric measurements such as heart rate – which allows the site trial team to review in near real time. Technology can empower people to have greater involvement in their care, lessen the burden of participating in a trial as well as deliver high quality, meaningful patient endpoint data so all stakeholders benefit.