Blog
RSS FeedPosted by Michael Wonder on 13 Mar 2017
Review of the drug trials snapshots program of the US FDA: women in cardiovascular drug trials
13 March 2017 - Over the last 20 years, there have been concerns that too few women and minorities are enrolled ...
Posted by Michael Wonder on 01 Mar 2017
Public-private partnership speeds investigator access to cancer drugs
28 February 2017 - A new collaboration between pharmaceutical and biotech companies and the National Cancer Institute at the National ...
Posted by Michael Wonder on 20 Feb 2017
The European Medicines Agency and publication of clinical study reports: a challenge for the US FDA
20 February 2017 - The US FDA has been the standard of drug regulation worldwide for decades. ...
Posted by Michael Wonder on 14 Feb 2017
FDA drug trials snapshots and diversity when testing new drugs
13 February 2017 - Did you know that some drugs affect men and women differently? ...
Posted by Michael Wonder on 13 Feb 2017
The challenges of generating evidence to support precision medicine
13 February 2017 - Major recent advances in science and technology now enable new kinds of measurements that can characterise an ...
Posted by Michael Wonder on 19 Jan 2017
Six month market exclusivity extensions to promote research offer substantial returns for many drug makers
18 January 2017 - To incentivise pharmaceutical manufacturers to invest in areas of unmet medical need, policy makers frequently propose extending ...
Posted by Michael Wonder on 17 Jan 2017
Composite endpoints and the distortion of risk–benefit analysis
17 January 2017 - Evidence-based medicine is a reassuring phrase, but when we prescribe has the evidence for safety and efficacy ...
Posted by Michael Wonder on 11 Jan 2017
National Cancer Institute and drug companies aim to speed up clinical trials
11 January 2017 - The National Cancer Institute launched an effort Wednesday to speed up clinical trials by getting researchers ...
Posted by Michael Wonder on 04 Jan 2017
The changing face of clinical trials: the large pharmaceutical company perspective
4 January 2017 - Large pharmaceutical companies conduct clinical trials to evaluate efficacy and identify safety issues for candidate drugs as ...
Posted by Michael Wonder on 27 Dec 2016
Negative control outcomes: a tool to detect bias in randomised trials
27 December 2016 - Investigators have several design, measurement, and analytic tools to detect and reduce bias in epidemiological studies. One ...
Posted by Michael Wonder on 15 Dec 2016
Transforming evidence generation to support health and health care decisions
14 December 2016 - Making better choices about health and health care requires the best possible evidence. Unfortunately, many of the ...
Posted by Michael Wonder on 08 Dec 2016
Interpreting geographic variations in results of randomised, controlled trials
7 December 2016 - Clinical triallists generally accept the premise that surprising results in subgroups of a randomised, controlled trial most ...
Posted by Michael Wonder on 06 Dec 2016
Failure of investigational drugs in late-stage clinical development and publication of trial results
5 December 2016 - Many investigational drugs fail in late-stage clinical development. A better understanding of why investigational drugs fail can ...
Posted by Michael Wonder on 30 Nov 2016
Drug approval by regulators: who watches the watchers?
30 November 2016 - In the latest issue of The Lancet Oncology, Ian Tannock and colleagues discuss some important parameters governing ...
Posted by Michael Wonder on 29 Nov 2016
Quality of life, overall survival, and costs of cancer drugs approved based on surrogate endpoints
29 November 2016 - The lack of evidence of a clinically meaningful benefit for many cancer drugs approved by the US ...