Evolution or Revolution: Beyond Decentralized Clinical Trials (DCT)

How does one tell all these decentralized clinical trials companies apart? It likely comes down to how each company addresses patient centricity.
Patient with nurse

Sitting in a DCT session at the CNS Summit, an industry colleague asked me “How do I tell all these DCT companies apart?” I told her that it comes down to how each company addresses patient centricity.

Patient-centricity can often be confused with patient-facing technology, when really it comes down to patient choice and solutions that truly address patient access barriers. These barriers include:

  • Geographic – “The site is too far”
  • Physical – “I can’t get to the site”
  • Convenience – “I don’t have time for this”, and
  • Trust – “I don’t know that doctor/hospital/neighborhood/community”

We must ask patients “how are you most comfortable engaging with a clinician for a clinical trial?” and listen as they tell us: traditional site, virtual, community clinic, pharmacy or home.


Emergence of decentralized trials during the pandemic

It’s easy to get distracted by the pandemic bubble that heralded virtual patient participation as the magic elixir for a broken system. DCT emerged as a pragmatic way to ensure continuity of engagement with patients during the peak of lockdown. It was largely marked by a rapid uptick in adoption of existing technologies (eConsent, eCOA/ePRO and telemedicine platforms) that allowed sites and investigators to engage virtually with patients. However, as we design solutions for a Zoom fatigued post-COVID reality, a more nuanced picture emerges that contextualizes these solutions as a part of a broader ecosystem.


Evolution through virtual tool adoption

Post-pandemic, the value of virtual engagement is well-established. We will undoubtedly see trial designs evolve to facilitate seamless inclusion of eConsent, eCOA and telemedicine options. Adoption of virtual patient engagement tools will be buoyed by both standardization and a proliferation of services to support operationalization. A continually evolving landscape of devices and digital diagnostic will result in new validated digital endpoints, but even where digital endpoints are possible, innovation takes time and will face a protracted journey towards regulatory approval. In areas where digital assessments are not feasible or patient tolerance for virtual engagement is low, these models are useful tools, but do not adequately address all of the barriers that prevent patients from accessing clinical trials.


Revolutionizing investigator access

Revolutionary innovation will come by reimagining “sites” and operationalizing new models that will allow any investigator or clinician to offer their patients access to novel research. By shifting our focus to clinicians and investigators, we can deploy new clinical trial care delivery models that strengthen and streamline the connection between patients and their health care providers and improve outcomes.

To fully operationalize patient choice, these new models must reimagine clinical trial care delivered in a variety of settings, including clinics, mobile units and homes. Some industry experts insist that the technology already exists to deliver on new modalities, but it is not clear that virtual patient engagement apps address the needs of investigators and clinicians. As we ask clinicians to branch out to new care settings, can we continue to equip them with the same disjointed suite of point solutions that already discourage broader investigator participation? Will this perpetuate an untenable reliance on the established brick and mortar infrastructure?


Alternatively, can we identify the right questions as we develop the ecosystem solutions that can truly unblock patient access to realize the potential of democratized clinical trials.

  • Does it optimize for patient choice?
  • Does it empower all clinicians to be researchers in non-traditional settings?
  • Does it leverage user centric technology to drive efficiency and quality?
  • Does it support adoption and codification of best practices?
Kate Flathers

Kate Flathers, Head of Product

Kate is responsible for the evolution of the HE SaaS technology platform. Prior to joining Hawthorne, Kate spent 12 years launching products to improve clinical research. Starting at Phase Forward (subsequently Oracle), she was most recently VP Head of Product at OM1, where she launched their first NLP and AI-powered RWD data products across multiple therapeutic areas. She also was VP of Global Product Management at DrugDev, building the clinical operations platform that was acquired by IQVIA in 2017. Prior to her move to life sciences, Kate was at Kiva Systems, where she led the launch of the first fleet of the warehouse robots that were ultimately acquired by Amazon in 2012. Kate earned her Bachelor’s of Science in Electrical Engineering from Brown University.

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