Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 17 Sep 2017
Cheaper drug trials would lower prices: FDA chief
15 September 2017 - Decreasing the time and cost it takes to develop a drug would lower drug prices, FDA ...
Posted by Michael Wonder on 22 Aug 2017
What should patients be told about non-inferiority studies?
21 August 2017 - A non-inferiority trial is a study in which a new treatment is compared with an existing, already ...
Posted by Michael Wonder on 13 Aug 2017
A cancer conundrum: too many drug trials, too few patients
12 August 2017 - With the arrival of two revolutionary treatment strategies, immunotherapy and personalised medicine, cancer researchers have found ...
Posted by Michael Wonder on 02 Aug 2017
Evidence for health decision making — beyond randomised, controlled trials
2 August 2017 - A core principle of good public health practice is to base all policy decisions on the highest-quality ...
Posted by Michael Wonder on 13 Jul 2017
Multidimensional evidence generation and FDA regulatory decision making defining and using “real-world” data
13 July 2017 - Evidence linking interventions with health outcomes is the basis for good health care decision making. ...
Posted by Michael Wonder on 12 Jul 2017
FDA collaborates to promote safety, quality in clinical trials done in India
12 July 2017 - After more than 16 hours of travel, we touch down in Mumbai late in the evening ...
Posted by Michael Wonder on 19 Jun 2017
Emerging use of early health technology assessment in medical product development: a scoping review of the literature
20 June 2017 - Early health technology assessment is increasingly being used to support health economic evidence development during early stages ...