Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 22 Nov 2017
Re-evaluating eligibility criteria for oncology clinical trials: analysis of investigational new drug applications in 2015
22 November 2017 - Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. ...
Posted by Michael Wonder on 22 Nov 2017
Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement
22 November 2017 - Excessive or overly restrictive eligibility criteria can slow trial accrual, jeopardise the generalisability of results, and limit ...
Posted by Michael Wonder on 22 Nov 2017
Mendelian randomisation
21 November 2017 - Mendelian randomisation uses genetic variants to determine whether an observational association between a risk factor and an ...
Posted by Michael Wonder on 14 Nov 2017
The “utility” in composite outcome measures
14 November 2017 - Measuring what is important to patients. ...
Posted by Michael Wonder on 16 Oct 2017
Cancer drug study data was falsified, says AstraZeneca
14 October 2017 - An early lab study supporting a cancer drug bought by British drugmaker AstraZeneca was falsified, the ...
Posted by Michael Wonder on 10 Oct 2017
Gatekeeping strategies for avoiding false-positive results in clinical trials with many comparisons
10 October 2017 - Clinical trials characterizing the effects of an experimental therapy rarely have only a single outcome of interest. ...