Clinical research certainly has evolved over the past three decades. There are more trials crossing a broader spectrum of indications, and advances in study design and execution have dramatically changed the way drugs and medical devices are evaluated and sold.
But perhaps no change has been more significant than the growth in engagement on the part of patients and their advocates.
As Premier Research’s Vice President, Patient and Stakeholder Engagement (PASE), Juliet Moritz has viewed this evolution up close — and so has Alan Thomas, founder of an organization that advocates on behalf of people afflicted with ataxia, a rare neurological disorder.1 Mr. Thomas and Ms. Moritz share their observations on how patient engagement is changing the face of clinical research in Premier Research’s latest Premier Voices podcast.
“The level of patient engagement … has definitely increased over the last few years,” said Mr. Thomas, founder of the advocacy group Ataxia & Me. “I think the era of a pharmaceutical company not being able to speak to the patient has ended.” Today, industry “is not doing things to you, they are doing things with you, and that’s a big change.”
You have to listen
Pharma companies increasingly appreciate the value of listening to patients and accounting for their needs, Mr. Thomas said. When arranging to meet with patients, for example, they need to factor in preparation and travel time, which are often longer for people who suffer from chronic conditions. They also need to communicate effectively, using language that patients and their families and caregivers understand.
Social media has been a boon for patient groups, he added. “A big advantage of social media is to get the awareness of the condition out to a bigger audience,” he said. Facebook, Twitter, and other platforms allow people to easily connect with pharmaceutical companies, and those interactions can pave the way for more personal avenues of engagement.
Ms. Moritz has seen the level and quality of patient contact accelerate over the past five to seven years, corresponding with the growing maturity of social media. “We are now routinely speaking to sponsors, pharma companies, biotech companies, and device companies early on in the development process … to say, ‘Have you spoken with the patient and their caregiver and their advocates? Do you really understand the questions we need to be asking and how we need to be asking them, and what the outcomes of the program could mean to them?’ ”
‘Missing an opportunity’
Small pharma and biotech companies that lack dedicated patient access and advocacy staff should still commit resources to working with advocacy groups that represent the populations they serve, Ms. Moritz said — and the earlier, the better. “Industry needs to shift those discussions with the patients, their caregivers, their families, and their advocates earlier and earlier in the development process, because if you’ve already gotten to Phase II or Phase III and then you start talking to patients … you’re missing the opportunity to really design and execute patient-centered research.”
Sponsors that lack the resources to develop their own patient engagement functions can seek guidance from their contract research organizations, she added. “CROs often have unique insight in to what it’s like to live with the disease, and those insights can be very impactful” in designing and executing research programs.
“When I started in the industry, this was not a discussion we were having,” Ms. Moritz said. “Patients were expected to want to participate in research because, of course, everyone wants access to the potential new medication and therapy. But now we realize that patients, their caregivers, and their advocates actually need a place at the table. They need to have a voice in the conceptualization, design, and execution of research programs, and we’re seeing the regulatory agencies supporting that position as well.”
Want to know more? Check out the latest episode of Premier Voices.
Follow Alan and Ataxia & Me online: