Today, we sit down with Angela Radcliffe, a seasoned expert who formerly led R&D Digital Performance Improvement & Innovation at Bristol Myers Squibb, to dissect the stagnation within big pharma and identify the hurdles that have historically prevented significant advancements in clinical trial methodologies. Angela brings to light the complex web of factors contributing to the industry’s resistance to change, from regulatory rigidity to the unexpected consequences of digital transformation. In this discussion, we explore how these factors have created a maze of inefficiency and how embracing a patient-centric model could be the key to revitalizing the clinical trial landscape. Join us as Angela Radcliffe provides her valuable insights on surmounting these barriers to forge a path toward a more dynamic and responsive clinical trial system.

Moe Alsumidaie: Angela, as we look towards the future, how do you see new business models integrating into the clinical trial industry?

Angela Radcliffe: The clinical trial industry stands at a crossroads, requiring a shift toward new business models prioritizing patient-led and designed engagement and diversity. Our current system, while operational, is sluggish and lacks the diversity needed for robust clinical trials. We need to fill trials on day one, which demands a substantial investment in patient education and health literacy, focusing on the drug development process. For instance, if we had started educating the public about clinical research 20 years ago versus study-by-study as we initiate them, we might now see the fruits of that labor. Furthermore, patient engagement must be consumer-driven, where patients not only volunteer for research but also influence its conduct. We should integrate clinical research as a care option, creating a seamless blend with clinical care, thus making research more accessible and appealing to potential participants.

Moe Alsumidaie: Given your experience, what are the primary factors that have inhibited significant change in clinical trials over the past few decades?

Angela Radcliffe: Regulatory challenges were prominent obstacles initially, but as digital transformation took precedence, we faced an unexpected burden. The influx of new technologies, while intended to streamline operations, inadvertently added complexity. For example, clinical study coordinators now juggle multiple digital systems, increasing the risk of error and inefficiency. We’ve also struggled to see patients as active consumers. There’s a disconnection in how we perceive patients when we’re at work versus when we’re caring for a sick child at home. Until we bridge this gap and place user and patient experience at the forefront, guided by solid science, we won’t see the change we need.

Angela Radcliffe

Moe Alsumidaie: Can you explain the concept of pre-competitiveness in Big Pharma and its potential benefits?

Angela Radcliffe: Pre-competitiveness is about Big Pharma companies joining forces on non-competitive grounds to address common challenges that benefit the industry. Take, for instance, the collaborative healthcare effort Haven that was formed by the leaders of Amazon, Berkshire Hathaway, and JPMorgan Chase. Although it didn’t succeed, it’s an example of how collaboration can aim to improve healthcare outcomes. In our industry, consortia like TransCelerate, DTRA and IMI work tirelessly, though often slowly, to elevate the industry. Sharing tools, intelligence, and expertise can improve patient outcomes without hindering individual company missions or competitive advantages in market.

Moe Alsumidaie: What tangible actions can be taken by Big Pharma companies and stakeholders to effect meaningful change?

Angela Radcliffe: To bring about meaningful change, consortia need to be more dynamic, and we must consider whether change will come from within the industry or from external forces. We need to embrace force factors, like the demands for more research options from patients and pressures from decentralized trials. To move forward, we must amplify collaboration, enhance our listening to stakeholders like physicians and patients, and multiply our innovative efforts. Sadly, things like innovation and patient engagement for study design are often the first things cut when the industry faces financial pressures. We are in a time like that now, but it is short-sighted to stop taking more ‘shots on goal’. We have to try new things constantly to improve our processes and importantly, we must foster a positive, collaborative spirit centered around the shared mission of improving patient health.

Moe Alsumidaie: How can Big Pharma engage with younger generations to instill a sense of responsibility and understanding about the importance of clinical trials?

Angela Radcliffe: There’s a profound need to educate the younger generation about the significance of clinical research. We lack a comprehensive campaign that truthfully portrays the individual and societal benefits. If we consider the “truth campaign” against tobacco, it’s clear that public service campaigns can profoundly impact youth perception and behavior. We should include clinical research in school curricula, from elementary to university levels, and combat misinformation with campaigns that clarify what clinical research involves. This could also include integrating clinical trial education into science classes, demystifying the process, and presenting clinical research as a viable and rewarding career path.

Moe Alsumidaie: With the rapid advancements in digital platforms and AI, how can these tools be leveraged for better clinical trial outcomes?

Angela Radcliffe: The potential for new technologies and AI in healthcare is substantial. The most immediate application is operational efficiency – automating mundane tasks to allow healthcare professionals to focus on more complex and impactful work. We must upskill our workforce to harness these technologies effectively. For example, AI can facilitate more personalized patient care through computer vision, enabling clinicians to consult with family members across distances. This intersection of technology and healthcare promises to enhance not only operational efficiency but also patient care and engagement.

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Moe Alsumidaie Chief Editor
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.