Blog
RSS FeedPosted by Michael Wonder on 22 May 2023
The role of disclosures: helping to understand oncology clinical trial endpoints
18 May 2023 - FDA researchers wanted to see whether consumers understand oncology endpoints in DTC television ads, and whether disclosures ...
Posted by Michael Wonder on 02 Mar 2022
Progression-free survival: it is time for a new name
1 March 2022 - Progression-free survival refers to the time from randomisation or initiation of treatment to the occurrence of disease ...
Posted by Michael Wonder on 08 Oct 2020
Use of real world evidence to support FDA approval of oncology drugs
8 October 2020 - Real world evidence has gained increased attention in recent years as a complement to traditional clinical trials. ...
Posted by Michael Wonder on 06 Oct 2020
Demystifying the estimand framework: a case study using patient-reported outcomes in oncology
1 October 2020 - Patient-reported outcome measures describe how a patient feels or functions and are increasingly being used in benefit–risk ...
Posted by Michael Wonder on 14 Aug 2018
Five predictions for AI and real world data in oncology
14 August 2018 - As progress in oncology care is advancing faster than ever -- especially due to the work ...
Posted by Michael Wonder on 22 Dec 2016
FDA officials call for including adolescents in adult oncology trials
20 December 2016 - A team of officials at the US FDA are calling for a "culture shift" by drug ...
Posted by Michael Wonder on 16 Sep 2015
Bristol-Myers Squibb’s Opdivo (nivolumab) receives breakthrough therapy designation from U.S. Food and Drug Administration for advanced renal cell carcinoma
16 September 2015 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy ...