The Evolution of Technology Enablement in Long-term Follow-up Studies

Follow-up-studies-patient-scans

SUMMER 2022, THE EVIDENCE FORUM, WHITE PAPER

Summary

Evolution of Technology Enablement in Long-term Follow-up StudiesBreakthroughs in medical care and treatment advancement are enabling children and adults with chronic illnesses to live longer than ever before. Consequently, it is essential to evaluate care patterns and patient outcomes over a longer period to identify and address unmet need due to latent adverse effects and/or negative changes in quality of life over time. As such, long-term follow-up (LTFU) studies, while not new, are becoming increasingly important in evaluating the long-term effectiveness and safety of investigational and marketed products. While not all LTFU studies are part of regulatory mandates, all LTFU studies share several common challenges in data accrual, clinician burden and participant loss to follow-up.

Technological advancement, in both the clinical and consumer sectors, has revolutionized data collection capabilities, accessibility, and traceability while in some cases reducing costs. The wider development of automated data capture and linking of real-world data (RWD), and development of associated real-world evidence (RWE), has the potential to alleviate many of the most pressing pain points in LTFU research. The recent pandemic highlighted the need to be less reliant on in-person data collection to avoid gaps in patient care and ensure research study continuity.

In this article, we explore:

  • An overview of long-term follow-up studies
  • How real-world data technology enablement can optimize long-term follow-up study design and enhance RWE generation
  • The current challenges and considerations for moving from a manual to automated data collection
  • Our approach to incorporating digital and technology-based solutions into long-term follow-up studies

Authors

Dara Stein, BSc, MSc, Senior Research Scientist, Real-World Evidence
Evidera, a business of PPD, part of Thermo Fisher Scientific

Mariah Baltezegar, MBA, Vice President and Head PPA Study Innovation, Real-World Evidence
Evidera, a business of PPD, part of Thermo Fisher Scientific

Julia Riley, Director, Development Operations
PPD, part of Thermo Fisher Scientific

Terry Wilcox, PhD, Former Vice President, Real-World Evidence
Evidera, a business of PPD, part of Thermo Fisher Scientific

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