# Are pragmatism and ethical protections in clinical trials a zero-sum game?

## TL;DR

This paper explores whether ethical protections for vulnerable participants in clinical trials conflict with or support pragmatic trial design.

## Contribution

The paper introduces a novel analysis of how ethical protections can enhance trial pragmatism in specific design domains.

## Key findings

- Additional ethical protections can promote pragmatism in some PRECIS-2 domains.
- The relationship between ethical protections and trial pragmatism is complex and context-dependent.
- Researchers should seek ways to align ethical protections with pragmatic trial goals.

## Abstract

Randomized controlled trials with pragmatic intent aim to generate evidence that directly informs clinical decisions. Some have argued that the ethical protection of informed consent can be in tension with the goals of pragmatism. But the impact of other ethical protections on trial pragmatism has yet to be explored.

In this article, we analyze the relationship between additional ethical protections for vulnerable participants and the degree of pragmatism within the PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) domains of trial design.

We analyze three example trials with pragmatic intent that include vulnerable participants.

The relationship between ethical protections and trial pragmatism is complex. In some cases, additional ethical protections for vulnerable participants can promote the pragmatism of some of the PRECIS-2 domains of trial design. When designing trials with pragmatic intent, researchers ought to look for opportunities wherein ethical protections enhance the degree of pragmatism.