Blog
RSS FeedPosted by Michael Wonder on 16 Nov 2023
Data sharing a a new era for research funded by the US Government
15 November 2023 - In January 2023, the NIH implemented its new Data Management and Sharing Policy. ...
Posted by Michael Wonder on 13 Dec 2022
Target trial emulation: a framework for causal inference from observational data
12 December 2022 - Quantifying the effect of a treatment on a clinical outcome—causal inference—requires the comparison of outcomes under different ...
Posted by Michael Wonder on 06 Dec 2022
Data sharing and the growth of medical knowledge
5 December 2022 - In medical research, data sharing facilitates discovery and innovation, transparency, and reproducibility, and, ultimately, trust in ...
Posted by Michael Wonder on 04 Aug 2022
U.S. regulators defend requiring more data on monkeypox drug
4 August 2022 - As U.S. monkeypox cases rise, U.S. health agencies in a medical journal article published on Wednesday ...
Posted by Michael Wonder on 25 Feb 2022
Assessment of public opinion on transparency at the US Food and Drug Administration
18 February 2022 - Historically, the US FDA has considered much of the oversight of clinical trials, interactions with companies, and ...
Posted by Michael Wonder on 13 Feb 2022
The FDA and its new commissioner must follow the science
13 February 2022 - The FDA has the awesome responsibility to protect public health by ensuring the safety and effectiveness of ...
Posted by Michael Wonder on 26 Jan 2022
Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA
27 January 2022 - Pfizer wants to intervene in a Texas federal lawsuit seeking information from the U.S. FDA used ...
Posted by Michael Wonder on 22 Jan 2022
COVID-19 vaccines and treatments: we must have raw data, now
19 January 2022 - Data should be fully and immediately available for public scrutiny ...
Posted by Michael Wonder on 15 Sep 2021
FDA advances data, IT modernisation efforts with new Office of Digital Transformation
15 September 2021 - FDA prioritises effective and efficient use of data by reorganising IT, data and cybersecurity functions to ...
Posted by Michael Wonder on 19 May 2021
COVID-19 vaccines: In the rush for regulatory approval, do we need more data?
18 May 2021 - After rollout under emergency authorisation, manufacturers of COVID-19 vaccines now have their sights on regulatory approval. ...
Posted by Michael Wonder on 30 Apr 2021
AstraZeneca struggles with data needed for COVID-19 vaccine’s approval
29 April 2021 - Company is assembling data for FDA review, hoping for another stamp of regulatory backing in global rollout ...
Posted by Michael Wonder on 30 Nov 2020
Deploying big data to determine how well vaccines work
29 November 2020 - As the initial rollout starts, it’s time to start planning a registry to monitor health outcomes. ...
Posted by Michael Wonder on 28 Sep 2020
Worst-rank score methods—a non-parametric approach to informatively missing data
28 September 2020 - A previous JAMA Guide to Statistics and Methods article briefly reviewed non-parametric statistics. ...
Posted by Michael Wonder on 25 Aug 2020
F.D.A. ‘grossly misrepresented’ blood plasma data, scientists say
24 August 2020 - Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about ...
Posted by Michael Wonder on 24 Aug 2020
FDA may fine clinical trial sponsors that don’t report data
24 August 2020 - The US FDA has said it will penalise sponsors of clinical trials that do not report ...