igital health data technology is transforming clinical research and therapeutic product development from a straight-line model (with data flowing “from beginning to end” to inform sequential, gated phases) to a self-reinforcing feedback loop–a digital virtuous loop that informs the entire product development lifecycle in an iterative manner.

ne fundamental challenge facing life scientists is establishing standards for clinical data sharing that enable decentralized or digital trials. During the 30-plus years that the Clinical Data Interchange Standards Consortium (CDISC) has been in place, the ways that the biotechnology and pharmaceutical industries think about data have changed significantly.

ore than 18 million Americans have been diagnosed with cancer in the past decade, according to the American Cancer Society. This is by any measure a staggering figure. And while the past century’s scientific advancements have greatly improved detection, treatment, prognosis, and life expectancy for these patients, there is still much work to be done in the search for a cure.

here’s more than one way to architect a decentralized clinical trial (DCT). While this flexible model has many benefits, it can be overwhelming to bring together all the right elements to operationalize a trial that’s predominantly digital. Every trial is unique, so it is not realistic to templatize (impose a standard implementation template on) a DCT. But four common, fundamental components combine to facilitate a seamless, patient-centric DCT.

“It’s like a trial in a box, but each box is a little bit different,” said Steve Rosenberg, CEO of a cloud-based platform company that powers decentralized clinical trials. Even with a DCT’s inherent optionality, foundational components can ease implementation and improve execution.

eal-world evidence (RWE) policy is evolving around the world, with increasing recognition that RWE offers a value proposition for all stakeholders in the research, development, and healthcare ecosystem. In the European Union, the European Health Data Space (EHDS), if optimally implemented, has the potential to advance the concept of a learning healthcare system that enables not only sharing of data but also sharing of insights. This concept provides a vision for a future when improved, more connected use of data will enhance decisions on therapies for individual patients, with feedback loops from clinical practice to research and development, and then back again, with each helping the other to make better decisions faster.

he pharmaceutical industry has embraced digital transformation as a means of generating data that enables faster and better-informed decision making. Digitization has resulted in improved cohesion and overall effectiveness across the pharmaceutical value chain.