Blog
RSS FeedPosted by Michael Wonder on 14 Nov 2019
10 year update on study results submitted to ClinicalTrials.gov
14 November 2019 - A decade after ClinicalTrials.gov launched a database for reporting results of clinical trials, the database includes results ...
Posted by Michael Wonder on 31 Oct 2019
Where were the women? Gender parity in clinical trials
30 October 2019 - On October 3, the FDA approved co-formulated tenofovir alafenamide and emtricitabine (F/TAF) for HIV prevention in at-risk ...
Posted by Michael Wonder on 30 Oct 2019
Model assisted designs for early phase clinical trials: simplicity meets superiority
30 October 2019 - Drug development enterprise is struggling because of prohibitively high costs and slow progress. ...
Posted by Michael Wonder on 28 Oct 2019
Where next for randomised controlled trials in global health?
26 October 2019 - The 2019 Nobel Memorial Prize in Economic Sciences was awarded to three economists—Esther Duflo, Abhijit Bannerjee, and ...
Posted by Michael Wonder on 24 Oct 2019
Older patients (still) left out of cancer clinical trials
24 October 2019 - A decade before he became the US Surgeon General, Vivek Murthy, MD, published a 2004 study in ...
Posted by Michael Wonder on 16 Oct 2019
RWE to supplement RCTs: FDA projects continue
15 October 2019 - The US FDA has been working with several different data and research companies to further its ...
Posted by Michael Wonder on 12 Oct 2019
Canada's decision to make public more clinical trial data puts pressure on FDA
11 October 2019 - Last March, Canada's department of health changed the way it handles the huge amount of data ...
Posted 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 09 Sep 2019
Clinical trials to combat reproductive cancers
9 September 2019 - The Australian Government is investing up to $15 million in targeted clinical trials to improve treatments and ...
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 ...