English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Plus monthly

Global: Zendy Tools annual

Global: Zendy Tools monthly

Global: Zendy Free Plan

The past few years have seen an increasing number of initiatives aimed atintegrating information generated outside of confirmatory randomised clinicaltrials (RCTs) into drug development. However, data generated non-concurrentlyand through observational studies can provide results that are difficult tocompare with randomised trial data. Moreover, the scientific questions thesedata can serve to answer often remain vague. Our starting point is to useclearly defined objectives for evidence generation, which are formulatedtowards early discussion with health technology assessment (HTA) bodies and areadditional to regulatory requirements for authorisation of a new treatment. Wepropose FACTIVE (Flexible Augmented Clinical Trial for Improved eVidencEgeneration), a new class of study designs enabling flexible augmentation ofconfirmatory randomised controlled trials with concurrent andclose-to-real-world elements. These enabling designs facilitate estimation ofcertain treatment effects in the confirmatory part and other, complementarytreatment effects in a concurrent real-world part. Each stakeholder should usethe evidence that is relevant within their own decision-making framework. Highquality data are generated under one single protocol and the use ofrandomisation ensures rigorous statistical inference and interpretation withinand between the different parts of the experiment. Evidence for thedecision-making of HTA bodies could be available earlier than is currently thecase.

Generating the right evidence at the right time: Principles of a new class of flexible augmented clinical trial designs