An Approach to Solving the Complex Clinicogenomic Data Landscape in Precision Oncology: Learnings From the Design of WAYFIND-R, a Global Precision Oncology Registry

Abstract

Precision oncology, where patients are given therapies based on their genomic profile and disease trajectory, is rapidly evolving to become a pivotal part of cancer management, supported by regulatory approvals of biomarker-matched targeted therapies and cancer immunotherapies. However, next-generation sequencing (NGS)-based technologies have revealed an increasing number of molecular-based cancer subtypes with rare patient populations, leading to difficulties in executing/recruiting for traditional clinical trials. Therefore, approval of novel therapeutics based on traditional interventional studies may be difficult and time consuming, with delayed access to innovative therapies. Real-world data (RWD) that describe the patient journey in routine clinical practice can help elucidate the clinical utility of NGS-based genomic profiling, multidisciplinary case discussions, and targeted therapies. We describe key learnings from the setup of WAYFIND-R (NCT04529122), a first-of-its-kind global cancer registry collecting RWD from patients with solid tumors who have undergone NGS-based genomic profiling. The meaning of 'generalizability' and 'high quality' for RWD across different geographic areas was revisited, together with patient recruitment processes, and data sharing and privacy. Inspired by these learnings, WAYFIND-R's design will help physicians discuss patient treatment plans with their colleagues, improve understanding of the impact of treatment decisions/cancer care processes on patient outcomes, and provide a platform to support the design and conduct of further clinical/epidemiologic research. WAYFIND-R demonstrates user-friendly, electronic case report forms, standardized collection of molecular tumor board-based decisions, and a dashboard providing investigators with access to local cohort-level data and the ability to interact with colleagues or search the entire registry to find rare populations. Overall, WAYFIND-R will inform on best practice for NGS-based treatment decisions by clinicians, foster global collaborations between cancer centers and enable robust conclusions regarding outcome data to be drawn, improve understanding of disparities in patients' access to advanced diagnostics and therapies, and ultimately drive advances in precision oncology.

FIG 1.

WAYFIND-R design. ^aReadiness is defined by local precision oncology maturity (sufficient uptake of NGS testing, possibility of policy changes, and reimbursement) and how beneficial implementing WAYFIND-R will be at that stage. ^bA signed and dated informed consent form is obtained from patients. The participant must have signed the informed consent form before inclusion and exclusion criteria are checked and confirmed, at which point the patient can be enrolled. CGP, comprehensive genomic profiling; MTB, molecular tumor board; NGS, next-generation sequencing; RECIST, Response Evaluation Criteria In Solid Tumors; WES, whole-exome sequencing; WGS, whole-genome sequencing.

FIG 2.

Key challenges and learnings from WAYFIND-R. eCRF, electronic case report form; RWD, real-world data.

FIG 3.

WAYFIND-R data sharing and access framework. A signed and dated informed consent form is obtained from patients. eCRF, electronic case report form; EDC, electronic data capture; ISC, independent scientific committee.