Blog
RSS FeedPosted by Michael Wonder on 28 Sep 2018
CDER conversation: complex innovative trial designs
25 September 2018 - Complex innovative trial designs – including the use of adaptive, Bayesian, and other novel statistical approaches ...
Posted by Michael Wonder on 25 Sep 2018
Cost of clinical trials for new drug FDA approval are fraction of total tab
24 September 2018 - Clinical trials that support FDA approvals of new drugs have a median cost of $19 million, ...
Posted by Michael Wonder on 23 Sep 2018
FDA proposes stiff fines for failing to report clinical trials
20 September 2018 - Pharmaceutical companies could face penalties of up to US$10,000 per day. ...
Posted by Michael Wonder on 20 Sep 2018
Using evidence from randomised controlled trials in economic models: what information is relevant and is there a minimum amount of sample data required to make decisions?
21 September 2018 - Evidence from randomised controlled trials is used to support regulatory approval and reimbursement decisions. ...
Posted by Michael Wonder on 18 Sep 2018
Harvard Professor's attack on pharma's clinical trials is absurd
18 September 2018 - Dr. Marcia Angell, a senior lecturer at Harvard Medical School and the first woman to serve as ...
Posted by Michael Wonder on 15 Sep 2018
Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource
12 September 2018 - Following the 2012 EC guideline, sponsors must ensure that all trials registered on EUCTR since 2004 disclose ...
Posted by Michael Wonder on 31 Aug 2018
Choice of control group in randomised trials of cancer medicine: are we testing trivialities?
31 August 2018 - Several trials in cancer medicine over the past 5 years share two common features: first, they were ...
Posted by Michael Wonder on 29 Aug 2018
FDA launches new pilot to advance innovative clinical trial designs as part of agency’s broader program to modernise drug development and promote innovation in drugs targeted to unmet needs
29 August 2018 - Today, the U.S. FDA announced a new pilot program (“Complex Innovative Designs Pilot Meeting Program”) in which ...
Posted by Michael Wonder on 28 Aug 2018
Data enclaves for sharing information derived from clinical and administrative data
28 August 2018 - The promise that big data will transform health care has yet to be fulfilled. ...
Posted by Michael Wonder on 28 Aug 2018
Co-ordinated clinical trials could help more Australians
29 August 2018 - Every year about 1000 clinical trials start in Australia, with cancer the most frequently targeted condition. ...
Posted by Michael Wonder on 25 Aug 2018
FDA says sponsors should limit placebo controlled trials in cancer
23 August 2018 - FDA released draft guidance on Thursday to debunk the notion that FDA requires the use of ...
Posted by Michael Wonder on 21 Aug 2018
FDA analysis shows similar success rates for paediatric trials using clinical and surrogate outcomes
21 August 2018 - An analysis by US FDA officials published earlier this month finds that there is a similar ...
Posted by Michael Wonder on 15 Aug 2018
FDA advances efficient approaches to designing and conducting cancer clinical trials
14 August 2018 - Over the past decade, advances in understanding of cancer biology have led to the development of targeted ...
Posted by Michael Wonder on 06 Aug 2018
MHRA clarifies post-Brexit clinical trials rules
8 August 2018 - The MHRA has clarified how the UK’s clinical trials rules will function in partnership with the ...
Posted by Michael Wonder on 18 Jul 2018
$50 million to provide life-saving support to cancer patients
18 July 2018 - The Australian Government will provide $50 million to support some of Australia’s sickest patients, battling the most ...