Blog
RSS FeedPosted by Michael Wonder on 16 Jan 2018
Atezolizumab, pembrolizumab, nivolumab in urothelial carcinoma: studies of direct comparison are useful
4 January 2018 - Four dossier assessments involving comparisons between immunotherapies and chemotherapies for the same therapeutic indication in 2017/comparison ...
Posted by Michael Wonder on 15 Jan 2018
German watchdog calls for direct comparison of cancer immunotherapies
16 January 2018 - Germany’s drug assessment body has criticized a lack of data directly comparing drugs in a promising ...
Posted by Michael Wonder on 09 Jan 2018
Finding RCTs of new drugs: searches in trial registries require specific adaptations
5 January 2018 - In their article in the Journal of Clinical Epidemiology, Marco Knelangen, Elke Hausner, Sibylle Sturtz, and ...
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 13 Nov 2017
Nearly half of recent EU approvals based on a single pivotal study
10 November 2017 - A recent study found that 45% of marketing authorizations granted in the EU from 2012 to ...
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 ...