How Clinical Trials Can Thrive in the Digital Era

The Digital Medicine Society (DiMe) CEO Jennifer Goldsack and Takeda’s Head of Digital Health Sciences, Data Sciences Institute Shoibal Datta describe the current landscape of digitized clinical trials and discuss the business imperatives and strategic decisions needed to realize the full promise of digital in developing effective new therapies for patients.

PE: As we emerge from the COVID-19 pandemic, is there still a case for digital in clinical trials?

Jennifer Goldsack: Yes, absolutely. Even before the pandemic we put one in five new drugs back on the shelf with no conclusive answer about their safety and efficacy because we were shutting down 20% of clinical trials due to recruitment challenges. Technical success rates continue to sit at around 5%. And even when we can bring a new molecule all the way through to market, it’s taking 10-15 years to make that new therapy available to patients. As the pandemic wanes, volunteer participants—the lifeblood of the clinical trial industry—are expecting hyper-personalized and low-friction interactions driven by their increasing exposure to digital in every aspect of their life. Today pharma also struggles with a huge unmet need for new medical products and pressure to generate new revenue streams as they face more patent cliffs. I don’t see another way to address these growing challenges without fully embracing digital.

Shoibal Datta: I agree. Digital technologies offered enormous promise to reduce participant burden and increase the reach of clinical trials to more diverse populations long before the pandemic. COVID-19 definitely spurred the industry into action, but the differentiator that digital innovation has on drug development is being determined now by those organizations prioritizing the intentional use of all digital tools to optimize our ability to develop new therapies for patients. Digital strategies in clinical trials are embedded into our ways of working at Takeda and we are committed to realizing their promise.

PE: The use of digital tools in clinical trials has been steadily increasing. Are we getting close to achieving digital as the status quo in clinical trials?

SD: No, we are not. Although a tremendous amount of progress has been made in the last three years, we are still in the very early stages of adapting to and learning how to navigate this new digital world at scale. Digital success will not be achieved by individual point solutions. Incumbents across the clinical research ecosystem, as well as new entrants—for example the device manufacturers, the decentralized trial platform providers—must collaborate and learn from one another to build this future. Biopharma needs to learn how to integrate digital into its pipeline strategy, which will require support for an entirely new way of working across the drug development lifecycle. At Takeda, we are fortunate to enjoy broad leadership support and are convinced that digitizing our processes is going to optimize them for patients. We are collaborating with our partners across the ecosystem and collaborating with organizations such as DiMe to develop new ways of working, supporting our colleagues to successfully execute these new digital strategies, and creating new cross-functional teams to ensure that deep digital expertise is embedded into every one of our clinical program teams.

JG: Honestly? Not very close. We’ve seen the number of sponsors using digital endpoints increase by orders of magnitude over the last three years and sustained growth and interest in decentralized clinical trials. However, we’re only scratching the surface of how digital can improve the overall effectiveness, efficiency, equity, and patient centricity of clinical trials. This isn’t saying that no one is thinking this way yet. Those pharma companies embracing digital in a holistic way are already reaping the benefits of faster and more inclusive recruitment and better data powering better decisions, sooner. Takeda is a good example of this, but there’s a lot of work to do for the industry as a whole.

PE: What will it take for digital to become a core competency in the pharma industry?

JG: It will require a two-pronged approach. First, strong, strategic leadership from the top. Second, meaningful investment in the skills of the current pharma workforce and technical infrastructure they depend on. And I cannot emphasize enough the importance of supporting the pharma workforce to best succeed in the digital era. When we dig into confusion and resistance, we see a misunderstanding of what digital is intended to do for clinical trials. Not only is digital not coming to replace the hardworking teams committed to developing new therapies, it’s here to make that job easier. We already see Takeda’s commitment to upskilling and the benefits that follow. They are providing resources like DiMe’s Digital Fundamentals for Pharma course across the enterprise so each contributor understands how they can use and benefit from digital tools and technologies.

SD: We see education as critical to developing the digital clinical trials ecosystem to maturity. It is not enough to simply develop the tools and digital services ecosystem. We must also learn how and when to use these tools. While we may be digital natives in our personal lives, conducting rigorous clinical research harnessing the full power of today’s digital tools is not something that is well established in our field. The language is different, the approaches are different, and the risks are different, and we need to learn them and be comfortable with them before going to scale.

PE: What are the business and patient imperatives to not fall behind in the race to digitize clinical trials?

SD: This is an exciting time of change and inevitable evolution. Even beyond clinical trials, the practice of healthcare is rapidly changing. In the past three years there has been a shift of primary care from the clinic to local pharmacies and people’s homes. The needs and expectations of patients and clinical research participants are changing. We pride ourselves in following a simple but profound value system based on patient, trust, reputation and business. In that order. Digital approaches to clinical research are simply the right thing to do for patients. They allow us to offer choice and meet every patient where they prefer to be met. This also makes clinical trials more resilient, diverse and opens the door to a deeper understanding of disease than what the legacy model affords us. Those who choose to be early in this space will be able to better navigate inherently disruptive change in an increasingly competitive landscape to bring life-changing therapies to patients.

JG: It’s pretty simple; the current status quo in clinical trials is not sustainable. The digitization of clinical trials is certainly not going to solve all of the issues facing the clinical trials enterprise, but digital approaches offer real pathways to a transformed approach to drug development. And it’s becoming clear that digital strategies are necessary for any pharmaceutical company looking to increase their rates of technical success, speed the development of new drugs to market, and take a more inclusive approach to ensure our industry delivers value to all of the patients our industry exists to serve. Organizations who prioritize fit-for-purpose digital strategies and appropriately prepare their teams to deliver on these strategies will pull away from the competition as benefits are compounded rapidly over time.