On June 19, 2022, DIA’s Global Annual Meeting returned to Chicago, bringing together industry clinicians, regulators, scientists, academics, and more to discuss the biggest challenges facing life sciences today.

While DIA 2022 officially provided four days worth of content spanning over 13 talk tracks and hundreds of speakers, our team had three major takeaways from this year’s event.

‍

The ascent of decentralized clinical trials continues with promising new ROI analysis

As McKinsey noted in their June 2021 report “No place like home? Stepping up the decentralization of clinical trials,” the DCT capabilities of our industry are rapidly expanding. Nowhere was this more evident than at DIA 2022, with the recently released Tufts CSDD analysis spearheading the conference’s focus.

On Monday, Kenneth Getz (Executive Director/Professor, Tufts CSDD; Founder/Board Chair, CISCRP, Tufts University School of Medicine) and Pamela Tenaerts (Chief Scientific Officer, Medable) led attendees through their findings from the jointly authored paper.

The paper is the industry’s first analysis of the impact of decentralized trials and showcases how pharmaceutical companies can generate a 5x return on investment (ROI) over time in Phase 2 clinical trials, and a 13x ROI in Phase 3 trials.

For an hour, Ken and Pam explained how decentralized clinical trials reduce clinical trial cycle times, lower screen failure rates, and decrease the number of protocol amendments in order to generate their value.

As Pam noted on her LinkedIn post after presenting - “Money spent on #DCTs is well spent with an #ROI of 5x for the total phase 2 and 13x for phase 3.

Points to remember

  • The model is based on real data. Protocol performance and contract value data
  • It is a conservative base case
  • We are committed to more data to refine and rerun the model

Of course, We do #DCTs for more than the ROI, to make trials easier for people to participate, to reflect the population living with the condition under study, and to get more and better evidence and reliable data.

I’ve been working in trials for 30 years. Those better trials have never felt closer than before, especially with the movement to #communitybased clinical trials and #qualitybydesign.”

‍For more on this topic, or to read Tufts CSDD’s paper, click here.‍

There’s real work being done evolving hybrid and decentralized trials to better account for all stakeholders

The work of digital, hybrid, and decentralized clinical trial organizations was on full display. Digital Medicine Society (DiMe), Clinical Trials Transformation Initiative (CTTI), TransCelerate BioPharma Inc., Decentralized Trials & Research Alliance (DTRA), and Society for Clinical Research Sites (SCRS) highlighted the work being done in establishing core sets of standards for hybrid, decentralized, and remote trials. Best practices, regulatory and guidance discussions, and multi-stakeholder panels showcased efficient novel clinical trial methodologies that included perspectives from all stakeholders. The end result was an established knowledge base that identified how to move forward to a more technology-enabled #clinicaltrials system that better represents our world’s population.

‍

‍