Blog
RSS FeedPosted by Michael Wonder on 16 Jan 2019
Challenges of non-intention-to-treat analyses
15 January 2019 - Over the past 5 decades, the randomised clinical trial has become the gold standard for evaluation ...
Posted by Michael Wonder on 18 Dec 2018
Establishing the effectiveness of procedural interventions: the limited role of randomised trials
18 December 2018 - Procedural interventions comprise a large and growing component of medical care. Patients, physicians, health care organisations, and ...
Posted by Michael Wonder on 12 Dec 2018
Metastasis-free survival in prostate cancer: faster drug approvals, better drugs?
12 December 2018 - On 13 February 2018, the US FDA granted marketing authorisation to apalutamide for treatment of non-metastatic castration-resistant ...
Posted by Michael Wonder on 01 Oct 2018
Congratulations. Your study went nowhere.
23 September 2018 - Researchers should embrace negative results instead of accentuating the positive, which is one of several biases that ...
Posted 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 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 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 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 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 ...