Blog
RSS FeedPosted 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 01 Apr 2019
The stepped wedge cluster randomised trial: what it is and when it should be used
1 April 2019 - The basic premise of a stepped wedge cluster randomised trial is that all clusters start in the ...
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 15 Mar 2019
Health Canada begins release of clinical data on drugs and devices
14 March 2019 - Health Canada launched two public databases on Wednesday as the first step in making clinical information ...
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 04 Mar 2019
Cluster randomised trials
4 March 2019 - Cluster randomised trials randomise groups of individuals rather than individuals themselves to interventions. ...
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 ...
Posted by Michael Wonder on 18 Jan 2019
Lilly reports results of Phase 3 soft tissue sarcoma study of Lartruvo
18 January 2019 - Lartruvo in combination with doxorubicin previously showed an overall survival benefit in soft tissue sarcoma in a ...
Posted by Michael Wonder on 17 Jan 2019
FDA is urged to mandate disclosure of clinical trial summaries as pilot program stalls
16 January 2019 - One year after the FDA launched a voluntary pilot program to release clinical study reports, which ...