Theoretical Issues for Global Cumulative Treatment Analysis (GCTA)

TL;DR

This paper discusses the theoretical and practical challenges of Global Cumulative Treatment Analysis (GCTA), a continuous, integrated approach to adaptive trials involving all patients as implicit participants.

Contribution

It introduces GCTA as a novel extension of adaptive trials and explores the theoretical issues in its design and implementation.

Findings

Identifies key theoretical challenges in GCTA design

Proposes preliminary approaches to address GCTA issues

Highlights the implications of GCTA for trial methodology

Abstract

Adaptive trials are now mainstream science. Recently, researchers have taken the adaptive trial concept to its natural conclusion, proposing what we call "Global Cumulative Treatment Analysis" (GCTA). Similar to the adaptive trial, decision making and data collection and analysis in the GCTA are continuous and integrated, and treatments are ranked in accord with the statistics of this information, combined with what offers the most information gain. Where GCTA differs from an adaptive trial, or, for that matter, from any trial design, is that all patients are implicitly participants in the GCTA process, regardless of whether they are formally enrolled in a trial. This paper discusses some of the theoretical and practical issues that arise in the design of a GCTA, along with some preliminary thoughts on how they might be approached.