Incorporating Site-less Trials into Drug Development: A Framework for Action

Aug 4, 2019 | Digital Clinical Trials, Digital Health, Site-less Trials, Telehealth, Virtual Clinical Trials

Incorporating Site-less Trials into Drug Development A Framework for Action

A group of academic medical centers came together to study the emergence of site-less clinical trials. They considered the pervasiveness of telemedicine platforms, smartphone apps, wearable sensors, cloud computing infrastructure, not to mention machine learning and AI are all evolving faster than the culture of clinical research can keep up. They argue that the conservative, risk-averse nature of traditional clinical research is hindering progressive drug development. They articulate that it is now time to examine alternatives for collecting real-world data in home settings, for example.

Published a couple years ago, already great change has transformed the landscape even further. The research team included:

  • University of Washington, WA
  • Center Point Clinical Services, PA
  • University of Rochester Medical Center, NY
  • CSM Fargo, ND
  • Kinexum, Harper’s Ferry, WV
  • Trialogics, Wilmington, DE
  • Newcastle University, UK
  • University of North Carolina, NC
  • Teva Pharmaceuticals (Boston, MA)

The First Remote Study

In 2011, Pfizer conducted the first clinical trial of an FDA—approved study using web and smartphone-based technologies to recruit and manage participants entirely from their homes. Known as the REMOTE (Research on Electronic Monitoring of Overactive Bladder Treatment Experience), the feasibility study was initiated in response to an increasingly tough regulatory drug development environment with A) rising costs B) lengthening cycle times C) escalating levels of protocol complexity and D) dynamic regulatory environments. This study was terminated early there were plenty of lessons learned which the authors review in this study –the strengths and the weaknesses of its specific web-based components definitely triggered interest in the potential of the technology-driven clinical trial—and emerging methodologies and technologies to help conventional methods of drug development move toward “patient-centricity.”

Site-less CRO Model

The study team considered the site-less CRO model where pharmacists and other health care professionals offered useful and timely counseling for protocol compliance by regulator phone and videoconferencing sessions. They found that this is a flexible approach, in many cases, for managing clinical trial participants directly from their homes.

An expert panel was organized in Dallas, Texas, to discuss advancing pathways for site-less CRO and other remote clinical trial practices, factoring into account investigator, sponsor and regulatory perspectives.

Findings

The study team found that hybrid models can work very well—real-time, site-less management of clinical trials that augment traditional research and development methods by infusing data from a broader, more diverse array of patients in real-world practice settings. Furthermore, it was found that this emerging hybrid methodology can be quite effective as the proactive identification of safety profiles and operational issues in real time.

The team suggests that the emerging site-less CRO represents a critical bridge to alternative trial models, including “large sample trials” that strive to answer one or two questions using data derived from representative patient populations treated in typical clinical settings.

The Transitionary Model: Site-less CRO

This model can augment today’s research as a bridge to more systematic and consistent leveraging of virtual technologies to support the hybrid clinical trial of the future—where the protocol authors automatically know to consider patient-centric tools where and when it makes sense—without question. To get to that place of the future the study authors believe coordinated communication among investigators, sponsors, regulators and patients will be needed to develop standardized strategies for incorporating site-less CROs into current and future study design.

Lead Researchers

Irl B. Hirsch, MD 

Joe Martinez, RPh, PDE, PPCE 

Ray Dorsey, MD, MBA 

Gerald Finken, RPh, MS 

Alexander Fleming, MD 

Chris Gropp 

Philip Home, DM, DPhil 

Daniel I Kaufer, MD 

Spyros Papapetropolous, MD, PhD 

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