Blog
RSS FeedPosted 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23 August 2018 - FDA released draft guidance on Thursday to debunk the notion that FDA requires the use of ...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 ...
Posted by Michael Wonder on 17 Jul 2018
Federal Government to announce $50 million custom cancer drug trial
17 July 2018 - Almost 600 Queenslanders will have their cancer’s DNA tested to identify the drugs that will keep ...
Posted by Michael Wonder on 28 Jun 2018
Bias, operational bias, and generalisability in Phase II/III trials
27 June 2018 - Adaptive clinical trial designs improve the efficiency of the drug development process by allowing treatment decisions to ...
Posted by Michael Wonder on 20 Jun 2018
Finding cancer patients is the pharma industry’s unlikely challenge
20 June 2018 - Doctors will need to test 100 patients to find one candidate. ...
Posted by Michael Wonder on 14 Jun 2018
Effect of cross-over in oncology clinical trials on evidence levels in early benefit assessment in Germany
13 June 2018 - In oncology clinical trials, cross-over is used frequently but may lead to uncertainties regarding treatment effects. ...
Posted by Michael Wonder on 09 Jun 2018
Clinical trial design and dissemination: comprehensive analysis of clinicaltrials.gov and PubMed data since 2005
6 June 2018 - Well conducted clinical trials are widely regarded as the best source of evidence on the efficacy and ...
Posted by Michael Wonder on 06 Jun 2018
Clinical trial participants’ views of the risks and benefits of data sharing
7 June 2018 - Sharing of participant-level clinical trial data has potential benefits, but concerns about potential harms to research participants ...
Posted by Michael Wonder on 30 May 2018
Multiplicity considerations in clinical trials
31 May 2018 - Making multiple comparisons increases the likelihood that a chance association could be interpreted as causal. ...