The current public health crisis has accelerated collecting data in a decentralized manner. The biopharmacuetical industry had already begun to harness transformative approaches to collecting data in novel ways, including from remote sources across a wide range of settings and using diverse modalities. The pandemic has proven to be a catalyst for an even more comprehensive set of solutions to collect critical evidence beyond the walls of the traditional study setting. Regulatory agencies propelled this trend by releasing new guidances.1
Each study requires a unique approach and has a different degree of decentralization that may be available. The endpoints of interest, design (retrospective, prospective, hybrid), geography, clinical assessments, disease markers (genetic, biomarker), patient generated data, setting of care, and availability of external real world data each contribute to the decision of whether a particular design has attributes that can benefit from a more decentralized approach.
With so many factors that influence design, UBC’s team of epidemiologists, clinical scientist, and health policy experts have established a practical assessment across a key set of these domains. With a new wave of decentralization feasibility upon us, this assessment is one of the most critical first steps our clients undertake.
The UBC Decentralized Research Playbook is intended to help inform and offer a practical assessment method to our partners who are looking to most effectively leverage decentralized techniques and technologies to deliver on their research programs. UBC is offering this playbook to help you plan, prioritize and educate internal partners and leaders as you help your company enter the world of decentralized approaches to late stage product development and postmarketing evaluations.