Blog
RSS FeedPosted by Michael Wonder on 25 Mar 2020
Treating COVID-19—off-label drug use, compassionate use, and randomised clinical trials during pandemics
24 March 2020 - In the 2014 Ebola outbreak, close to 30 000 individuals developed Ebola viral disease, and numerous therapies were ...
Posted by Michael Wonder on 24 Mar 2020
Global regulators map out data requirements for phase 1 COVID-19 vaccine trials
24 March 2020 - Global regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine ...
Posted by Michael Wonder on 24 Mar 2020
Coronavirus drug to be trialled on frontline health workers
25 March 2020 - Australia is moving towards a new coronavirus preventive trial for frontline healthcare workers as the number of ...
Posted by Michael Wonder on 23 Mar 2020
Rush to raise funds for large COVID-19 drug trial in Australian hospitals
23 March 2020 - Australian researchers behind a new clinical trial of two drugs to treat COVID-19 are desperate to ...
Posted by Michael Wonder on 18 Mar 2020
Coronavirus (COVID-19) update: FDA issues guidance for conducting clinical trials
18 March 2020 - The U.S. Food and Drug Administration today issued a guidance for industry, investigators and institutional review ...
Posted by Michael Wonder on 04 Mar 2020
When a drug study abruptly ends, volunteers are left to cope
3 March 2020 - A participant might commit months or years to a drug trial, only to see it vanish overnight. ...
Posted by Michael Wonder on 18 Feb 2020
Paying clinical trial participants: legal risks and mitigation strategies
18 February 2020 - Offering remuneration to participants in cancer trials can promote recruitment and retention. ...
Posted by Michael Wonder on 18 Feb 2020
Randomised clinical trials of artificial intelligence
17 February 2020 - As patient data are increasingly captured digitally, the opportunities to deploy artificial intelligence, especially machine learning, ...
Posted by Michael Wonder on 16 Feb 2020
RWE: cost and time savings entice sponsors as pitfalls linger
14 February 2020 - The New England Journal of Medicine published an article earlier this week raising questions about the ...
Posted by Michael Wonder on 20 Jan 2020
Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study
17 January 2020 - Failure to report the results of a clinical trial can distort the evidence base for clinical practice, ...
Posted by Michael Wonder on 14 Jan 2020
Incidental imaging findings in clinical trials
13 January 2020 - Clinical trial end points are outcome measures used to assess the efficacy and safety of an ...
Posted by Michael Wonder on 05 Jan 2020
Beyond “Intent‐to‐treat” and “Per protocol”: improving assessment of treatment effects in clinical trials through the specification of an estimand
27 December 2019 - There is a key problem in randomised clinical trials as outcomes can be distorted due to ...
Posted by Michael Wonder on 11 Dec 2019
Strategic need for large prospective studies in different populations
9 December 2019 - Retrospective studies, in which well-characterized individuals with a particular disease are compared with control individuals without the ...
Posted by Michael Wonder on 01 Dec 2019
Adaptive design clinical trials for drugs and biologics guidance for industry
29 November 2019 - This document provides guidance to sponsors and applicants submitting investigational new drug applications, new drug applications, biologics ...
Posted by Michael Wonder on 14 Nov 2019
Watched by Apple
14 November 2019 - After taking over media, social communication, and the consumer economy, the forces of digital innovation are moving ...