ArticleTrials2022
The COVID-19 pandemic as a catalyst for innovation: a regulatory framework to assess fit-for-purpose innovative approaches in clinical research.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed.
- Use of Computer Vision with Conventional Video Recordings of Gait in Older Adults: A Scoping Review.Healthcare (Basel, Switzerland) · 2026Review
- New Benchmarks on Protocol Amendment Experience in Oncology Clinical Trials.Therapeutic innovation & regulatory science · 2024Article
- Remote Monitoring and Data Collection for Decentralized Clinical Trials.JAMA network open · 2024Article
- Standards for clinical trials for treating TB.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023Article
- Ethical challenges of clinical trials with a repurposed drug in outbreaks.Medicine, health care, and philosophy · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The COVID-19 pandemic has had a devastating impact on individuals and multiple aspects of our society including healthcare and clinical research. The silver lining is that the pandemic also served as a catalyst for wider adoption of innovative approaches in clinical research, notably the use of mobile or remote services, and digital technologies. Regulators, clinical study investigators, clinical study participants, sponsors, and other stakeholders collaborated to adopt measures that ensured safe participation in clinical studies whilst maintaining study integrity. In this article, we propose a regulatory framework for assessing fit-for-purpose innovative approaches in clinical research based on Roche/Genentech's experience during the COVID-19 pandemic with the aim to inform and encourage broader implementation of patient-centric and sustainable innovation in clinical research. Our goal is to contribute to ongoing discussions on introducing innovative approaches in clinical trials and eventually the development of globally harmonised guidelines.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.