Blog
RSS FeedPosted by Michael Wonder on 17 Sep 2017
Cheaper drug trials would lower prices: FDA chief
15 September 2017 - Decreasing the time and cost it takes to develop a drug would lower drug prices, FDA ...
Posted by Michael Wonder on 22 Aug 2017
What should patients be told about non-inferiority studies?
21 August 2017 - A non-inferiority trial is a study in which a new treatment is compared with an existing, already ...
Posted by Michael Wonder on 13 Aug 2017
A cancer conundrum: too many drug trials, too few patients
12 August 2017 - With the arrival of two revolutionary treatment strategies, immunotherapy and personalised medicine, cancer researchers have found ...
Posted by Michael Wonder on 02 Aug 2017
Evidence for health decision making — beyond randomised, controlled trials
2 August 2017 - A core principle of good public health practice is to base all policy decisions on the highest-quality ...
Posted by Michael Wonder on 13 Jul 2017
Multidimensional evidence generation and FDA regulatory decision making defining and using “real-world” data
13 July 2017 - Evidence linking interventions with health outcomes is the basis for good health care decision making. ...
Posted by Michael Wonder on 12 Jul 2017
FDA collaborates to promote safety, quality in clinical trials done in India
12 July 2017 - After more than 16 hours of travel, we touch down in Mumbai late in the evening ...
Posted by Michael Wonder on 19 Jun 2017
Emerging use of early health technology assessment in medical product development: a scoping review of the literature
20 June 2017 - Early health technology assessment is increasingly being used to support health economic evidence development during early stages ...
Posted 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 ...