Blog
RSS FeedPosted by Michael Wonder on 15 May 2017
Publication and reporting of the results of post-market studies for drugs required by the US FDA, 009 to 2013
15 May 2017 - Advancing scientific knowledge depends on the timely dissemination of research results, including those from medical product research ...
Posted by Michael Wonder on 11 May 2017
Efficient trial design — FDA approval of valbenazine for tardive dyskinesia
10 May 2017 - A well-executed development program that addresses both regulatory and clinical requirements is critical for making novel therapeutics ...
Posted by Michael Wonder on 04 May 2017
FDA and NIH release final template for clinical trial protocols
2 May 2017 - A little more than a year ago, FDA and NIH announced the availability of a draft template ...
Posted by Michael Wonder on 04 May 2017
The failure of solanezumab — How the FDA saved taxpayers billions
3 May 2017 - The failure of solanezumab offers a window into the U.S. drug regulatory system, particularly in the context ...
Posted by Michael Wonder on 02 May 2017
Disclosing the conflicts of interest of US Food and Drug Administration Advisory Committee members
2 May 2017 - The agency excludes many individuals because of conflicts of interest; it may, however, determine that the ...
Posted by Michael Wonder on 19 Apr 2017
Reevaluating eligibility criteria — balancing patient protection and participation in oncology trials
19 April 2017 - Specific patient populations are often excluded from oncology trials without clear reasons, which renders results less clearly ...
Posted by Michael Wonder on 05 Apr 2017
Differences in treatment effect size between overall survival and progression-free survival in immunotherapy trials: a meta-epidemiologic study of trials with results posted at ClinicalTrials.gov
4 April 2017 - Tan et al. compared treatment effect sizes between overall survival and progression-free survival in trials of ...
Posted by Michael Wonder on 04 Apr 2017
Evaluation of evidence of statistical support and corroboration of sub-group claims in randomised clinical trials
3 April 2017 - Many published randomised clinical trials make claims for subgroup differences. ...
Posted by Michael Wonder on 15 Mar 2017
Can a statistical method speed drug approvals?
13 March 2017 - Not likely, says F. Perry Wilson, MD. ...
Posted by Michael Wonder on 13 Mar 2017
Review of the drug trials snapshots program of the US FDA: women in cardiovascular drug trials
13 March 2017 - Over the last 20 years, there have been concerns that too few women and minorities are enrolled ...
Posted by Michael Wonder on 01 Mar 2017
Public-private partnership speeds investigator access to cancer drugs
28 February 2017 - A new collaboration between pharmaceutical and biotech companies and the National Cancer Institute at the National ...
Posted by Michael Wonder on 20 Feb 2017
The European Medicines Agency and publication of clinical study reports: a challenge for the US FDA
20 February 2017 - The US FDA has been the standard of drug regulation worldwide for decades. ...
Posted by Michael Wonder on 14 Feb 2017
FDA drug trials snapshots and diversity when testing new drugs
13 February 2017 - Did you know that some drugs affect men and women differently? ...
Posted by Michael Wonder on 13 Feb 2017
The challenges of generating evidence to support precision medicine
13 February 2017 - Major recent advances in science and technology now enable new kinds of measurements that can characterise an ...
Posted by Michael Wonder on 19 Jan 2017
Six month market exclusivity extensions to promote research offer substantial returns for many drug makers
18 January 2017 - To incentivise pharmaceutical manufacturers to invest in areas of unmet medical need, policy makers frequently propose extending ...