How the Pharmaceutical Industry Can Thrive in the Digital Age –

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December marks the one-year anniversary of the U.S. Food and Drug Administration (FDA) draft guidelines, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” More than a decade of progress has led to these advances, which is reflected in the industry’s adoption of these tools. The Digital Medicine Society’s library of digital terminals has surpassed 350 unique digital terminals used to evaluate new medical products. More than 100 sponsors use digital endpoints in dozens of therapy areas, measuring concepts ranging from cognition to physical activity and gait to glucose levels.

Beyond digital clinical measurements, digital solutions are maturing to address major challenges facing clinical research and hold tremendous promise to support key performance indicators (KPIs) for every member of our industry. We see how digital adhesion measurements ensure that sample size calculations are valid and that drug developers can accurately assess the safety and efficacy of new molecules. Other tools improve patient orientation, inclusivity, generalizability of results, participant retention, and technical success, while reducing turnaround times. As we strive to improve the medical product development process and accelerate the development of effective new therapies for patients, digital health solutions are becoming more available, affordable and anticipated in healthcare institutions by patients, clinicians and caregivers, raising expectations for trial participants.

Digital medical solutions are not a silver bullet, but deliberately integrating them into clinical development is the greatest resource we have to overcome challenges and advance the development of medical products for patients.

Towards implementation

A “digital” strategy can no longer be located within a compartmentalised digital or innovation team. It is essential to integrate digital throughout the company. For example, leveraging technology such as continuous monitoring can help reduce clinic visits during trials, reduce participant burden, travel costs (and reimbursements), leading to increased efficiency. and cost reduction.

The introduction of digital tools – from AI to identify participants to digital clinical parameters to demonstrate efficacy – does not change the basic science of drug discovery and development. Pharma companies with more mature digital strategies can focus on scale issues. How do you find supplier partners who offer complete solutions? How can we integrate multiple high-speed sensor data streams into our systems without designing bespoke solutions? How can we ensure that we are advancing equity and inclusion in our trials?

Pharmaceutical companies that do not address these issues of scale risk being left behind. The race to exploit digital technologies will likely have winners and losers, but it doesn’t have to be.

Educate for Success in the Digital Age

At Takeda, we see this change happening right before our eyes. Over the past few years, we have implemented comprehensive training in all parts of our R&D organization and are already seeing the benefits. Our clinical teams who have embraced digital health technologies have run several decentralized clinical trials, deployed numerous digital devices and in doing so, reduced patient burden and enabled a more diverse patient population to participate in clinical research. The next phase will lead to large-scale success. We would like digital health technologies to be part of all clinical trials. To ensure success – and to achieve our organizational digital transformation goals – we must define the value of digital within R&D, communicate that value to every employee, and equip them with the knowledge, tools and experience to execute their roles as we digitize the drug development process.

For us, the benefits are clear. In the past, digital transformations have left knowledge and skills gaps in various sectors. What some executives describe as “resistance to change” is likely a reminder of the burdens faced by teams being asked to adopt poorly designed solutions in the digital early days without knowing the massive advances made in the quality and relevance of the solutions today. today. Knowledge of the fundamentals of digital medicine – and how digital innovation can be deployed to meet the needs of teams across the clinical trial enterprise – is essential.

A successful digitization of the clinical trials business requires focus and investment and we realized we needed to educate our entire team to be successful. Building internal capacity for successful digitalization of clinical trials will also help us recruit and retain the best digital innovation talent in the industry.

Assemble the pieces

As Takeda lived through these challenges, DiMe heard from its community that barriers to developing and scaling digital health products were becoming more common. This indicated that more was needed to support the successful evolution of digital health. There is solid research and practice that dictates what good looks like in digital medicine.

Language: We need to help eliminate jargon for stakeholders who don’t live and breathe digital. We need to provide applied definitions of digital health tools and support them with examples from across the drug development lifecycle and around the world, including how regulatory considerations vary depending on the function of the tool in practice. Our colleagues need to recognize the power of digital tools to support them in their day-to-day work and expose this support at an enterprise level.

The landscape: trial design needs to better reflect current trends in participants’ daily lives, clinician preferences and regulations; the adoption of digital medicine is critical to success, including expanding access to address pressing and persistent recruiting challenges. This information should also include the dynamic regulatory environment highlighting trends to underscore that emerging regulations support patient-centric digital innovation.

Leverage: We need to equip our colleagues with training and support to help identify the right partners for successful digital health innovation strategies in drug development. We need to make connections on how cross-functional teams can leverage their expertise and recognize that new partners will emerge to support the success of these teams in achieving their digital strategies.

The lens: We need to educate stakeholders about the participant perspective, including the importance of representative study cohorts for generalizable and valid results and best practices for evaluating digital products in large populations. Numerical approaches hold great promise for improving long-standing disparities in trial access and the generalizability of trial results. Tools and resources can support a more inclusive approach to engaging patients for digital equity and success.

To succeed in this digital age, we need a collective understanding of digital medicine to enhance the effectiveness of our individual roles and responsibilities. Partners like DiMe create tools and companies like Takeda develop proof points. The growing knowledge gap will prevent us from advancing the ethical, effective, equitable and safe use of digital medicine to reinvent healthcare and improve lives. But with the right approach to honing the field, we can deliver on the promise of the digital age of clinical trials.

About the authors

Jennifer C. Goldsack founded and serves as CEO of the Digital Medicine Society (DiMe), a 501(c)(3) nonprofit organization dedicated to advancing digital medicine to optimize human health.

ChoibalShoibal Datta is the Head of Digital Health Sciences for the Data Science Institute at Takeda, where he is responsible for working with colleagues across the company to develop patient-centric digital strategies for the development of new settings, make studies more resilient through decentralized approaches, and help bring digital health innovations from R&D to commercialization.

Jesus Gomez-Navarro is a R&D Distinguished Fellow at Takeda and a board-certified medical oncologist with two decades of R&D experience and more than a decade prior in clinical care and academia.

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