Over the last four days, the DIA 2023 conference has Illuminated downtown Boston as thousands of “industry, regulatory, government, academics, and patients” come together to  “problem-solve, and discuss global and local challenges facing the life sciences community.”

Much like JP Morgan week and SCOPE before it, what happens at DIA often makes waves across our industry, helping set the tone for our future.

Thus, we’re providing some of the biggest and brightest takeaways from this week’s conference below. 

This year’s hottest topic: artificial intelligence (A.I.)

“This is NOT like nuclear proliferation, we can’t stop this.”   -Revolutionizing Life Sciences: How Diversity, Innovation, and AI are Accelerating the Future of Health

Artificial intelligence, known more commonly as A.I., was everywhere during this year’s show. There were just under 20 sessions total featuring the topic of artificial intelligence, with the show’s opening plenary highlighting how AI is accelerating the “future of health.”

Of note, presenters like Najat Khan, PhD, and the SVP/Global Head of Strategy & Operations for R&D at Janssen described a future vision of AI-enabled drug development. In her vision, AI supports everything from identifying better drug candidates to helping influence trial and endpoint design.

In terms of its impact on diversity and equity, Harvard Professor and Chair of the Department of Biomedical Informatics, Isaac Kohane MD, PhD, notes that in AI in clinical practice must require transparency, or else it risks failure in successfully diversifying trials. These levels of transparency must not only showcase what data was included in the model, but what was excluded as well. 

Adding to this, Dr. Kohane posed the ultimate question - Will doctors and medical care use AI in diagnosis and care capability? Or, will those facets remain human, with medical care only electing to use AI in the administrative process? 

How this plays out remains unclear, yet key for the future of medicine. But perhaps it was Microsoft’s Chief Medical Scientist, Junaid Bajwa, who showed us the roadmap ahead with his quote, “Diversity is the fuel of innovation. Innovation is the engine of transformation. AI is an accelerator of transformation.”

The next era of clinical development is already here today

With pharma now firmly existing in an era where decentralized and digital trials are accepted, a new era of clinical development is here. Nowhere was this more evident than at DIA, with dozens of sessions discussing the future of clinical development, how to deploy and integrate 

multiple digital data flows, and the need for a foundational platform.

Helping accelerate this next era are several players across pharma, from regulators like the FDA to key players like Medable and IQVIA, who have helped release evidence, toolkits, and other materials showing the value of DCT. 

During the session Driving the New Era of Clinical Development, Michelle Longmire highlighted how Medable and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) announced a comprehensive toolkit for Institutional Review Boards (IRBs) to help gain broader adoption of DCTs. 

Also helping to drive this change are organizations like the Tufts Center for the Study of Drug Development (Tufts CSDD), whose continuous work in showcasing the scaling value of digital and decentralized trials has helped attract larger players. 

Within the past year, companies such as Abbvie, GSK, Syneos, and others have signed multi-year deals with decentralized companies in order to build their “next model” of clinical conduct. This demonstrates sustained intention and adoption of digital methods for drug development.

According to panelists and presenters at DIA and beyond, the next era of clinical development should:

  • Enable organizations to have control of technology and partnerships in order to elevate site and participant experience
  • Be able to “own” the platform that’s providing the elevated site and participant experience
  • This means that organizations should ultimately be in final control of the platform’s experience, the modules and tools it uses, how those tools are operationalized, and how it’s modified for future use, regardless of whether or not they have created or licensed the platform.
  • Must use data from past trials to simulate unnecessary design choices and trials
  • Feel much more like everyday life
  • Accelerate the speed at which we conduct research, and
  • Feature “human-centered design” as one of its core principles.

Pharma’s focus on the patient hones in on “user experience.”

“A better user experience creates better data and better evidence,” noted Ingrid Oakley-Girvan, SVP, Value and Strategy at Medable.

This simple sentiment seemed to be widely touted at this year’s DIA, with sessions like “Better Experience for Better Data” from DataCUBED, and “How eConsent and eCOA can Improve Global Patient Experience, and Your Clinical Trial” from RWS, it has become evident that an easier site and participant experience is key for success. 

Walgreen’s Head of Digital Optimization and RWE Clinical Trials, Kendal Whitlock reinforced this during her session, noting that “end-to-end patient-centricity” is the key to maximizing trial quality and real-world-evidence.

Speaking on “bring-your-own-device” (BYOD), Signant Health’s Vice President of Product Intelligence and Positioning, and Principal eCOA Science, Bill Byrom noted that BYOD is spreading, becoming a more acceptable means of collecting ePRO data. For participants, this means they can keep the phones they’re most familiar with, for their trial. BYOD’s continued spread comes right off the heels of new ISPOR recommendations that help measure comparability under differing BYOD conditions. Outside of user experience, app security is paramount for BYOD’s success, as are time and date adjustments, and expanded reporting capabilities that enable BYOD to support trial data. 

If you’re looking to learn more about the power of clinical trial platforms, and why so many top pharma are choosing them, click here