Reconsidering 'minimal risk' to expand the repertoire of trials with waiver of informed consent for research.

ABSTRACT:

Background

Progress in therapeutic research is slowed by the regulatory burden of clinical trials, which provide the best evidence for guiding treatment. There is a long delay from evidence generation to adoption, highlighting the need for designs that link evidence generation to implementation.

Objective

To identify clinical trial designs that confer minimal risk above that inherent in clinical care, to obviate the need for cumbersome consenting processes to enrol patients in prospective clinical research studies. These designs extend the scope of the Learning Healthcare System, a framework for leveraging retrospective 'big data' to advance clinical research, to include data collected from prospective controlled trials.

Summary

Pragmatic trials may use simplified eli

SUBMITTER: Monach PA 

PROVIDER: S-EPMC8442055 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature