We recently had the opportunity to speak with Angela Radcliffe, a seasoned clinical research expert and advocate of data ethics. Angela has more than 20 years of experience in the industry and is deeply passionate about making a meaningful impact on healthcare. In our conversation with her, we discussed how the industry can work towards improving the lives of patients and clinical trial sites. Read on for more insights on our discussion with Angela.
What is your background?
I have been working in the healthcare sector for more than two decades, starting in clinical and payer spaces. Throughout my career, I have worked closely with thousands of patients, collaborated with tech companies, and partnered with industry peers to drive healthcare forward. I have extensive experience working on both the vendor and sponsor sides.
I have also participated in clinical trials, which has given me first-hand experience, including the use of Greenphire products, specifically ClinCard. My goal in participating in clinical research is to gain a better understanding of how we can make a positive impact.
Why do you work in clinical research and what drives your passion?
I lost my brother when he was 21 to a rare disorder that runs in our family – Long QT Syndrome. My family got involved in a clinical research study that found the gene in our family. This study has helped us manage and treat the condition, potentially saving the lives of 100 family members. I believe that participating in clinical research is a real gift.
I am passionate about research because it can make a real difference in healthcare. I am particularly concerned about homelessness. However, when we consider the bigger picture, research has the potential to help with every cause we care about, be it climate change, racial injustice, homelessness, or any other issue. It all comes down to research. For instance, by participating in a study related to substance abuse or mental health, we might be able to prevent someone from becoming homeless in the first place. By adding to the existing body of knowledge, we can help tackle the root cause of various societal issues.
Why do you consider patient convenience solutions a “must-have” instead of a “nice-to-have”?
Patient convenience solutions are becoming increasingly necessary in the healthcare industry. Patient-centricity has been a topic of discussion for years, but we still have a long way to go to ensure that patients and sites are a central focus. I recently conducted a LinkedIn poll about what we do wrong in investigator meetings, and the top two responses were “Where are the patients?” and “We are not focusing on the site needs at all.”
Patient convenience solutions must be designed to address the needs of both patients and sites. Two urgent industry trends are emerging: the shift towards new trial delivery models such as telemedicine, in-home care, and other DCT trial approaches, and the need to find real patients instead of “perfect” patients for trials through diversity plans. Without diversity plans, drugs will not be approved. Although the Fedora Act requires diversity action plans, there are currently no consequences for companies that do not have one. However, this may soon change.
Low consumer trust in healthcare means that pharma companies must start doing the right thing and policing themselves. Patient convenience solutions are now more necessary than ever. With the rise of DCT models and the urgent need for diversity, they are essential. If companies cannot keep their sites happy and remove barriers to participation, it will be difficult to enroll and retain participants from diverse communities. These patients require resources like immediate reimbursement, childcare and transportation; diversity action plans will only be fulfilled if these basic needs are met.
Are there any solutions that people view as nice to haves, but you feel should be must haves?
Considering the consistent challenges around enrollment and retention, solutions that are focused on removing the greatest barriers to participation should be seen as must haves. Whether it’s telemedicine / communication tools, logistics support, payment solutions or technology that centralizes and simplifies participant tasks, the industry needs to place a greater emphasis on the participant experience. While we are making strides in offering more flexibility and ease for participants, there is still work to be done.
Why do you feel pharma is so hesitant to pay stipends?
It seems that this reluctance stems from a long-standing belief that paying participants could lead to coercion. As someone who has served on an IRB at a major research center, I have seen this institutional legacy concern play out in real life. For example, the IRB once debated whether to provide umbrellas to patients participating in a study, fearing that such a gesture could be seen as coercive. This focus on what we are allowed to do and not allowed to do is misplaced. The tide is starting to change, with regulators leading the way on innovative approaches to data management. As this trend continues, the pharmaceutical industry may begin to shift its perspective on stipends. However, for now, the legacy holds on concerns over coercion and culture remains strong.
