Blog
RSS FeedPosted 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 ...
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 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. ...
Posted by Michael Wonder on 30 May 2018
Are big clinical trials relevant? Researchers disagree
29 May 2018 - Amid health care tailored to an individual’s DNA, do massive clinical trials that take years and involve ...
Posted by Michael Wonder on 11 Mar 2018
Key design considerations for adaptive clinical trials: a primer for clinicians
8 March 2018 - This article reviews important considerations for researchers who are designing adaptive clinical trials. ...
Posted by Michael Wonder on 14 Feb 2018
The stepped-wedge clinical trial
13 February 2018 - Evaluation by rolling deployment. ...
Posted by Michael Wonder on 24 Jan 2018
Characteristics of interim publications of randomised clinical trials and comparison with final publications
23 January 2018 - Publication of interim results of randomised trials can be consequential, potentially undermining trial integrity by unblinding or ...
Posted by Michael Wonder on 16 Jan 2018
FDA Commissioner on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs
16 January 2018 - Scientific progress and new drug innovation don’t take place in a vacuum. ...
Posted by Michael Wonder on 23 Dec 2017
Many FDA approved cancer drugs might lack clinical benefit
21 December 2017 - New research shows that less than half of the randomised controlled trials that support the approval of ...
Posted by Michael Wonder on 12 Dec 2017
Bringing early feasibility studies for medical devices back to the United States
12 December 2017 - Ten years ago, when medical device manufacturers wanted to gain early clinical experience with their new devices ...
Posted by Michael Wonder on 11 Dec 2017
Drug makers continue to owe FDA numerous clinical trials
7 December 2017 - Under various circumstances, the FDA may require a drug maker to run a post-marketing study, but ...
Posted by Michael Wonder on 07 Dec 2017
FDA required studies of approved drugs make a big difference for public health
7 December 2017 - Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be ...