Blog
RSS FeedPosted by Michael Wonder on 10 Oct 2019
FDA cuts red tape in diagnosis applications for cancer trials
10 October 2019 - Drug companies developing cancer treatments can fold the risk assessment of unapproved screening tests into their ...
Posted by Michael Wonder on 08 Oct 2019
FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
8 October 2019 - The U.S. FDA today announced that it has awarded 12 new clinical trial research grants totaling ...
Posted by Michael Wonder on 22 Sep 2019
Interacting with the FDA on complex innovative trial designs for drugs and biological products
20 September 2019 - This document provides guidance to sponsors and applicants on interacting with the FDA on complex innovative trial ...
Posted by Michael Wonder on 12 Sep 2019
When are RCTs required for breakthrough drugs, HDEs? JAMA study investigates
11 September 2019 - A new study in JAMA Network Open finds that drugs and medical devices approved by the ...
Posted by Michael Wonder on 09 Sep 2019
Who’s missing from breast cancer trials? Men, says the FDA
9 September 2019 - Men do get breast cancer, but they account for fewer than 1 percent of patients and often ...
Posted by Michael Wonder on 28 Aug 2019
FDA urges inclusion of men in breast cancer clinical trials
28 August 2019 - Men with breast cancer make up less than one percent of all breast cancer cases, but ...
Posted by Michael Wonder on 28 Aug 2019
Placebos and blinding in randomised controlled cancer clinical trials for drug and biological products: guidance for industry
28 August 2019 - This guidance provides recommendations to industry about the use of placebos and blinding in randomised controlled clinical ...
Posted by Michael Wonder on 29 Jul 2019
Harms from uninformative clinical trials
25 July 2019 - Individuals who enroll in clinical trials do so with the belief that their participation will help ...
Posted by Michael Wonder on 21 Jul 2019
Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices
21 July 2019 - The objective was to develop and pilot a tool to measure and improve pharmaceutical companies’ clinical trial ...
Posted by Michael Wonder on 09 Jul 2019
The fragility of phase 3 trials supporting FDA approved anti-cancer medicines: a retrospective analysis
8 July 2019 - The fragility index of trial results—ie, the minimum number of changes from non-events to events resulting in ...
Posted by Michael Wonder on 04 Jul 2019
Attempt to replicate clinical trials with real world data generates real world criticism, too
3 July 2019 - It’s one of the most seductive ideas in medicine: that “real-world evidence,” including data from electronic ...
Posted by Michael Wonder on 24 Jun 2019
Incorporating patient preferences in non-inferiority trials
24 June 2019 - Non-inferiority trials imply a trade-off between a loss in efficacy of a standard treatment in exchange for ...
Posted by Michael Wonder on 06 Jun 2019
FDA's Woodcock defends accelerated approvals and talks of culture shift in clinical trials
5 June 2019 - Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the ...
Posted by Michael Wonder on 21 May 2019
Google sister company Verily is teaming with big pharma on clinical trials
21 May 2019 - Pharma companies are looking to work with Verily, which is part of the Alphabet umbrella, as they ...
Posted by Michael Wonder on 13 May 2019
Considerations in demonstrating interchangeability with a reference product guidance for industry
9 May 2019 - This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable ...