Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 17 May 2022
Ethical considerations for the inclusion of patient reported outcomes in clinical research
17 May 2022 - An international consensus Delphi process was developed according to the Enhancing the Quality and Transparency of Health ...
Posted by Michael Wonder on 12 May 2022
Basket trials: review of current practice and innovations for future trials
10 May 2022 - Basket trials, one type of master protocol, emerged as a tool for evaluating biomarker-targeted therapies among multiple ...
Posted by Michael Wonder on 09 May 2022
Choices that fail health and wellbeing
5 May 2022 - NICE's expert group RAPID C-19, set up to ‘to ensure safe and timely patient access to treatments ...
Posted by Michael Wonder on 08 May 2022
Supporting innovation in Medicaid policy - interventions to increase adoption of RCTs
7 May 2022 - Randomised, controlled trials remain underutilised within the Medicaid program, even though state Medicaid programs regularly implement new ...
Posted by Michael Wonder on 06 May 2022
Patient reported outcome assessment must be inclusive and equitable
5 May 2022 - Patient reported outcomes are increasingly collected in clinical trials and in routine clinical practice, but strategies ...
Posted by Michael Wonder on 21 Apr 2022
Are high cost prescription drugs the price of innovation? Disclose the costs of clinical trials.
21 April 2022 - With 40% of Americans struggling to afford prescription medicines and many rationing or delaying initiation of lifesaving ...
Posted by Michael Wonder on 13 Apr 2022
FDA takes important steps to increase racial and ethnic diversity in clinical trials
13 April 2022 - Agency’s focus on inclusion in trials for all medical products aligns with Biden Administration’s cancer moonshot goal ...
Posted by Michael Wonder on 30 Mar 2022
Drug trials a ‘ticking time bomb’: ex-TGA agent
28 March 2022 - A former TGA official who led the regulator’s inspections program has warned that a lack of ...
Posted by Michael Wonder on 18 Mar 2022
Australian cancer patients to get improved access to clinical trials
17 March 2022 - Australian cancer patients will get improved access to local clinical trials through a new public-private partnership ...