Blog
RSS FeedPosted by Michael Wonder on 21 May 2019
Google sister company Verily is teaming with big pharma on clinical trials
21 May 2019 - Pharma companies are looking to work with Verily, which is part of the Alphabet umbrella, as they ...
Posted by Michael Wonder on 13 May 2019
Considerations in demonstrating interchangeability with a reference product guidance for industry
9 May 2019 - This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable ...
Posted by Michael Wonder on 13 May 2019
Two words to help Ned Sharpless revolutionise clinical trials: data standards
13 May 2019 - In the classic 1967 film “The Graduate,” young Benjamin Braddock was given one word of advice ...
Posted by Michael Wonder on 02 May 2019
Substandard control arms question the utility of some new cancer drugs
2 May 2019 - The rapid pace of new cancer drugs approved by the FDA, 16 in 2018 alone, is ...
Posted by Michael Wonder on 10 Apr 2019
FDA, Brigham and Women’s to test if RWE is ripe now for replacing clinical drug trials
10 April 2019 - Can real-world evidence substitute for a clinical drug trial that meets the full gold standard on data? ...
Posted by Michael Wonder on 10 Apr 2019
The evolving uses of “real world” data
9 April 2019 - The terms real world data and real-world evidence have entered the medical lexicon to refer to ...
Posted by Michael Wonder on 04 Apr 2019
The importance of predefined rules and pre-specified statistical analyses: do not abandon significance
4 April 2019 - For decades, statisticians and clinicians have debated the meaning of statistical and clinical significance. ...
Posted by Michael Wonder on 30 Mar 2019
Statement by FDA Commissioner, Director of FDA’s Center for Drug Evaluation and Research and Director of FDA’s Center for Biologics Evaluation and Research on expanded access–looking forward
29 March 2019 - For more than 30 years, the FDA has supported patients’ access to investigational medical products for ...
Posted by Michael Wonder on 27 Mar 2019
Effectiveness in the absence of efficacy: cautionary tales from real world evidence
21 March 2019 - Real-world data are collected outside of traditional clinical trials and may include electronic health records, patient registries, ...
Posted by Michael Wonder on 14 Mar 2019
Statement by FDA Commissioner on new strategies to modernise clinical trials to advance precision medicine, patient protections and more efficient product development
14 March 2019 - Modernizing clinical trials is an agency wide priority. ...
Posted by Michael Wonder on 09 Mar 2019
Marginal effects—quantifying the effect of changes in risk factors in logistic regression models
8 March 2019 - Marginal effects can be used to express how the predicted probability of a binary outcome changes ...
Posted by Michael Wonder on 02 Mar 2019
Treatment effects in multi-centre randomised clinical trials
1 March 2019 - It is common for treatments to be evaluated in clinical trials that involve many sites or centres, ...
Posted by Michael Wonder on 25 Feb 2019
Under representation of elderly in clinical trials: an analysis of the initial approval documents in the FDA database
25 February 2019 - A cross‐sectional, structured review of publicly available initial approval documents of FDA approved drugs was performed. ...
Posted by Michael Wonder on 23 Jan 2019
Modernising clinical trials for patients with cancer
23 January 2019 - Clinical trials involve evaluating and validating new therapies in humans and represent the fundamental means of making ...
Posted by Michael Wonder on 23 Jan 2019
Random-effects meta-analysis: summarising evidence with caveats
22 January 2019 - Questions involving medical therapies are often studied more than once. For example, numerous clinical trials have been ...