Blog
RSS FeedPosted by Michael Wonder on 14 Jul 2019
In praise of studies that use more than one generic preference-based measure
12 July 2019 - Generic preference-based measures of health-related quality of life are widely used as outcome measures in cost-effectiveness and ...
Posted by Michael Wonder on 09 Jul 2019
The fragility of phase 3 trials supporting FDA approved anti-cancer medicines: a retrospective analysis
8 July 2019 - The fragility index of trial results—ie, the minimum number of changes from non-events to events resulting in ...
Posted by Michael Wonder on 04 Jul 2019
Attempt to replicate clinical trials with real world data generates real world criticism, too
3 July 2019 - It’s one of the most seductive ideas in medicine: that “real-world evidence,” including data from electronic ...
Posted by Michael Wonder on 03 Jul 2019
Call for all sponsors to publish clinical trial results in EU database
3 July 2019 - The European Commission, the European Medicines Agency and the Heads of Medicines Agencies have co-signed a ...
Posted by Michael Wonder on 24 Jun 2019
Incorporating patient preferences in non-inferiority trials
24 June 2019 - Non-inferiority trials imply a trade-off between a loss in efficacy of a standard treatment in exchange for ...
Posted by Michael Wonder on 12 Jun 2019
Sask. Cancer Agency started chemotherapy drug trial without required Health Canada approval
11 June 2019 - Agency says it 'proactively' paused trial 5 months after it started. ...
Posted by Michael Wonder on 06 Jun 2019
FDA's Woodcock defends accelerated approvals and talks of culture shift in clinical trials
5 June 2019 - Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the ...
Posted 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 16 Apr 2019
Labor to fast-track leukaemia drug trials
17 April 2019 - Patients with deadly blood cancers will get faster access to potentially life-saving drug trials if Labor ...
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. ...