Blog
RSS FeedPosted by Michael Wonder on 14 Jan 2020
Incidental imaging findings in clinical trials
13 January 2020 - Clinical trial end points are outcome measures used to assess the efficacy and safety of an ...
Posted by Michael Wonder on 05 Jan 2020
Beyond “Intent‐to‐treat” and “Per protocol”: improving assessment of treatment effects in clinical trials through the specification of an estimand
27 December 2019 - There is a key problem in randomised clinical trials as outcomes can be distorted due to ...
Posted by Michael Wonder on 11 Dec 2019
Strategic need for large prospective studies in different populations
9 December 2019 - Retrospective studies, in which well-characterized individuals with a particular disease are compared with control individuals without the ...
Posted by Michael Wonder on 01 Dec 2019
Adaptive design clinical trials for drugs and biologics guidance for industry
29 November 2019 - This document provides guidance to sponsors and applicants submitting investigational new drug applications, new drug applications, biologics ...
Posted by Michael Wonder on 14 Nov 2019
Watched by Apple
14 November 2019 - After taking over media, social communication, and the consumer economy, the forces of digital innovation are moving ...
Posted 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 ...