Blog
RSS FeedPosted by Michael Wonder on 25 Jul 2017
Revised guideline on first-in-human clinical trials
25 July 2017 - Guidance outlines strategies to identify and mitigate risks for trial participants. ...
Posted by Michael Wonder on 23 Jul 2017
Tackling submission and publication bias
17 July 2017 - Evoniuk and colleagues analysed whether submission and publication bias are based on study outcome. ...
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 22 Jun 2017
Clinical trials provide $1.1b to Australian economy: MTPConnect releases report on clinical trials ecosystem in Australia
21 June 2017 - MTPConnect today released a new report ‘Clinical Trials in Australia: the economic profile and competitive position ...
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 05 Jun 2017
Prima’s trial backs safety of metastatic breast cancer drug
5 June 2017 - The Lucy Turnbull-chaired biotech Prima Biomed has revealed new data that backs the safety of its ...
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 31 May 2017
South Australia slashes pathology, medical science jobs
31 May 2017 - Medical unions say timely patient treatments and diagnoses could be at risk after the South Australian ...
Posted by Michael Wonder on 30 May 2017
NICE to launch new evidence tool for medtech product developers
30 May 2017 - NICE is launching an online tool to help medtech companies get their products to patients faster. ...
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 25 May 2017
Medical research reforms to improve our future health
25 May 2017 - The Australian Government provides more than $800 million through the National Health and Medical Research Council each ...