Blog
RSS FeedPosted by Michael Wonder on 07 Oct 2022
The critical role of academic clinical trials in paediatric cancer drug approvals: design, conduct, and fit for purpose data for positive regulatory decisions
6 October 2022 - For decades, academic clinical trials consortia have collaborated to optimise outcomes for childhood cancers through evaluating incremental ...
Posted by Michael Wonder on 05 Sep 2022
Clinical trials: real world data plays early role in efforts to increase diversity
5 September 2022 - The use of real world data to help design clinical trials is nothing new but increasingly it ...
Posted by Michael Wonder on 30 Aug 2022
Accelerating clinical trials in the EU: publication of 2022-2026 workplan
30 August 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published the 2022-2026 workplan ...
Posted by Michael Wonder on 17 Aug 2022
Early phase oncology trials: why so many designs?
12 August 2022 - The past 30 years have seen a considerable effort on the part of statisticians to improve the ...
Posted by Michael Wonder on 10 Aug 2022
Cure Rare Disease receives FDA approval to administer first in human CRISPR therapeutic
10 August 2022 - Cure Rare Disease announces the approval from the US FDA to administer its very first therapeutic. ...
Posted by Michael Wonder on 04 Aug 2022
U.S. regulators defend requiring more data on monkeypox drug
4 August 2022 - As U.S. monkeypox cases rise, U.S. health agencies in a medical journal article published on Wednesday ...
Posted by Michael Wonder on 03 Aug 2022
Connecting electronic health records to clinical trials: how to embrace the promise of real world data
3 August 2022 - We all know that real world data from electronic health records could boost clinical trial efficiency ...
Posted by Michael Wonder on 02 Aug 2022
Patient reported outcome measures in clinical research
2 August 2022 - Health conditions may cause patients to feel ill and have impaired functioning in their daily lives. Thus, ...
Posted by Michael Wonder on 01 Aug 2022
Advancing innovative clinical trials to efficiently deliver medicines to patients
1 August 2022 - Complex innovative designs in clinical trials have the potential to increase efficiency and lower the cost of ...
Posted by Michael Wonder on 26 Jul 2022
‘No magic bullet’: For drug makers and the FDA, clinical trials on ultra rare diseases pose thorny challenges
26 July 2022 - Walker Burger is beside himself with worry. ...
Posted by Michael Wonder on 20 Jul 2022
Simulating colorectal cancer trials using real world data
20 July 2022 - Using real world data –based trial simulation approach, we aim to simulate colorectal cancer trials and ...
Posted by Michael Wonder on 12 Jul 2022
EMA launches pilot project on analysis of raw data from clinical trials
12 July 2022 - EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical ...
Posted by Michael Wonder on 15 Jun 2022
A first step towards best practice recommendations for the design and statistical analyses of pragmatic clinical trials: a modified Delphi approach
15 June 2022 - Pragmatic clinical trials are randomised trials implemented through routine clinical practice, where design parameters of traditional randomised ...
Posted by Michael Wonder on 14 Jun 2022
FDA’s treatment of China developed drugs spurs demands for multiregional clinical trials
14 June 2022 - China’s ambition to become a leader in the biopharma industry has been clear in the last ...
Posted by Michael Wonder on 18 May 2022
Toward incorporating health-related quality of life as co-primary endpoints in clinical trials: time to achieve clinical important differences and quality of life profiles
16 May 2022 - Besides morbidity and mortality, quality of life is a key outcome of cancer treatments. ...