Blog
RSS FeedPosted by Michael Wonder on 12 Jun 2017
Regulators in EU, Japan and US take steps to facilitate development of new antibiotics
12 June 2017 - EMA, PMDA and FDA align data requirements and agree on areas of convergence. ...
Posted by Michael Wonder on 06 Jun 2017
Workshop: addressing unmet needs of children with pulmonary arterial hypertension
6 June 2017 - The EMA, the United States FDA and Health Canada are co-organising a workshop to discuss the ...
Posted by Michael Wonder on 06 Jun 2017
The value of using registries to evaluate randomised clinical trial study populations
5 June 2017 - Randomised clinical trials are considered the gold standard of medical research and influence clinical practice, but they ...
Posted by Michael Wonder on 01 Jun 2017
Health policy trials
31 May 2017 - Clinical trials are most commonly associated with drugs and devices, but there are notable examples of trials ...
Posted by Michael Wonder on 29 May 2017
Designing clinical trials that accept new arms: an example in metastatic breast cancer
22 May 2017 - The majority of randomised oncology trials are two-arm studies that test the efficacy of new therapies against ...
Posted by Michael Wonder on 20 May 2017
How did Vertex win an FDA approval without running a clinical trial?
19 May 2017 - Vertex Pharmaceuticals scored a minor coup this week when the Food and Drug Administration signed off ...
Posted by Michael Wonder on 18 May 2017
Clinical trial participants should have a say in new drug pricing
18 May 2017 - People who volunteer to participate in clinical trials of new drugs provide a valuable service to ...
Posted by Michael Wonder on 17 May 2017
How patients are changing clinical trials
17 May 2017 - In September, the FDA approved a controversial drug to treat Duchenne muscular dystrophy, a rare but deadly ...
Posted by Michael Wonder on 15 May 2017
Publication and reporting of the results of post-market studies for drugs required by the US FDA, 009 to 2013
15 May 2017 - Advancing scientific knowledge depends on the timely dissemination of research results, including those from medical product research ...
Posted by Michael Wonder on 11 May 2017
Efficient trial design — FDA approval of valbenazine for tardive dyskinesia
10 May 2017 - A well-executed development program that addresses both regulatory and clinical requirements is critical for making novel therapeutics ...
Posted by Michael Wonder on 04 May 2017
FDA and NIH release final template for clinical trial protocols
2 May 2017 - A little more than a year ago, FDA and NIH announced the availability of a draft template ...
Posted by Michael Wonder on 04 May 2017
The failure of solanezumab — How the FDA saved taxpayers billions
3 May 2017 - The failure of solanezumab offers a window into the U.S. drug regulatory system, particularly in the context ...
Posted by Michael Wonder on 02 May 2017
Disclosing the conflicts of interest of US Food and Drug Administration Advisory Committee members
2 May 2017 - The agency excludes many individuals because of conflicts of interest; it may, however, determine that the ...
Posted by Michael Wonder on 19 Apr 2017
Reevaluating eligibility criteria — balancing patient protection and participation in oncology trials
19 April 2017 - Specific patient populations are often excluded from oncology trials without clear reasons, which renders results less clearly ...
Posted by Michael Wonder on 05 Apr 2017
Differences in treatment effect size between overall survival and progression-free survival in immunotherapy trials: a meta-epidemiologic study of trials with results posted at ClinicalTrials.gov
4 April 2017 - Tan et al. compared treatment effect sizes between overall survival and progression-free survival in trials of ...