Blog
RSS FeedPosted by Michael Wonder on 03 May 2026
US pushes real time clinical trials to eliminate “dead time” in approvals
1 May 2026 - The US FDA is testing “real time clinical trials,” which it says will provide faster access ...
Posted by Michael Wonder on 29 Apr 2026
FDA announces major steps to implement real time clinical trials
28 April 2026 - The US FDA today announced two major steps as part of an initiative to advance the implementation ...
Posted by Michael Wonder on 26 Feb 2026
Clinical equivalence and non-inferiority within health technology assessment
23 February 2026 - Non-inferiority and clinical equivalence clinical trials can be used to determine whether a health technology is no ...
Posted by Michael Wonder on 20 Feb 2026
One pivotal trial, the new default option for FDA approval — ending the two-trial dogma
18 February 2026 - This Sounding Board announces a new FDA policy that the default requirement for FDA approvals will be ...
Posted by Michael Wonder on 16 Jan 2026
FDA issues guidance on modernising statistical methods for clinical trials
12 January 2026 - The US FDA today published draft guidance designed to facilitate the use of Bayesian methodologies in ...
Posted by Michael Wonder on 03 Apr 2025
Platform clinical trials for the efficient evaluation of multiple treatments
31 March 2025 - For some medical conditions, including conditions without effective treatments, multiple promising but unproven therapies may exist, with ...
Posted by Michael Wonder on 21 Feb 2025
Harmonising HTA evidence needs and expectations: challenges and opportunities to improve evidence generation, ensure access and affordability
19 February 2025 - Conducting high quality health technology assessments requires high quality evidence. With evolving regulatory standards for faster approval ...
Posted by Michael Wonder on 12 Feb 2025
Factorial clinical trial designs
15 January 2025 - Clinical trials using factorial designs in which participants receive several randomised interventions simultaneously allow efficient evaluation of ...
Posted by Michael Wonder on 15 Nov 2024
Representativeness of studies required under Medicare’s coverage with evidence development program
13 November 2024 - Medicare beneficiaries are often inadequately represented in clinical studies supporting US Food and Drug Administration medical product ...
Posted by Michael Wonder on 22 Sep 2024
Ethical challenges associated with pragmatic and cluster RCTs
14 September 2024 - Pragmatic and cluster RCTs offer opportunities for advancing research but present ethical challenges. ...
Posted by Michael Wonder on 05 Jun 2024
Why should the FDA focus on pragmatic clinical research?
3 June 2024 - Traditional randomised clinical trials have long been a key tool underpinning drug and device development. ...
Posted by Michael Wonder on 20 Mar 2024
Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU
20 March 2024 - The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform aimed at ...
Posted by Michael Wonder on 08 Oct 2023
Clinical studies: you can see better with the second arm
6 October 2023 - In a statement to the EMA, the IQWiG emphasised that single-arm studies may be sufficient for ...
Posted by Michael Wonder on 28 Sep 2023
The use of historical controls in clinical trials
28 September 2023 - A randomised clinical trial is frequently the preferred research design for testing new medical treatments. Randomisation helps ...
Posted by Michael Wonder on 04 Sep 2023
The changing landscape of clinical trials in Australia
4 September 2023 - Examining the clinical trials landscape in Australia is important for governance and to expand knowledge about trial ...