Blog
RSS FeedPosted by Michael Wonder on 23 Jan 2023
Conditional power: how likely is trial success?
23 January 2023 - Because of the costs and potential risks to participants, clinical trials should be initiated or continued only ...
Posted by Michael Wonder on 11 Jan 2023
CDER director calls for simplifying clinical trials to boost diversity
10 January 2023 - Encouraging researchers and sponsors to simplify clinical trials and employ a fit for purpose protocol is ...
Posted by Michael Wonder on 13 Dec 2022
Target trial emulation: a framework for causal inference from observational data
12 December 2022 - Quantifying the effect of a treatment on a clinical outcome—causal inference—requires the comparison of outcomes under different ...
Posted by Michael Wonder on 04 Dec 2022
Statistical approaches to establishing bioequivalence
2 December 2022 - Requirements for submitting bioavailability and bioequivalence data in investigational new drugs, new drug applications, abbreviated new drug ...
Posted by Michael Wonder on 21 Nov 2022
Adjustment for baseline characteristics in randomised clinical trials
17 November 2022 - The purpose of randomisation in clinical trials is to ensure that there are no systematic differences between ...
Posted by Michael Wonder on 21 Oct 2022
FDA finalises multiple endpoints guidance
20 October 2022 - The US FDA on Thursday finalised guidance to sponsors on managing multiple outcomes in clinical trials ...
Posted by Michael Wonder on 09 Oct 2022
New federal incentives for diversity in clinical trials
8 October 2022 - In June 2022, the US House of Representatives passed legislation intended to increase the diversity of ...
Posted 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 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 ...