Blog
RSS FeedPosted by Michael Wonder on 27 May 2023
Adjusting for covariates in randomized clinical trials for drugs and biological products
26 May 2023 - This final guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomised ...
Posted by Michael Wonder on 22 May 2023
The role of disclosures: helping to understand oncology clinical trial endpoints
18 May 2023 - FDA researchers wanted to see whether consumers understand oncology endpoints in DTC television ads, and whether disclosures ...
Posted by Michael Wonder on 27 Mar 2023
Clinical trial considerations to support accelerated approval of oncology therapeutics
24 March 2023 - The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious ...
Posted by Michael Wonder on 27 Mar 2023
FDA outlines plan for digital health technologies for clinical trials
24 March 2023 - The US FDA plans to hold at least one public meeting and release several guidances on digital ...
Posted by Michael Wonder on 28 Feb 2023
My son’s time is running out due to a rare disease. The FDA needs to add more clinical trial flexibility.
28 February 2023 - My toddler, Wheeler, will probably not live to adulthood. Juvenile Batten disease — he has the ...
Posted by Michael Wonder on 16 Feb 2023
FDA to require diversity plan for clinical trials
16 February 2023 - US regulatory agency makes ‘big change’ to increase the number of participants from under-represented groups in drug ...
Posted by Michael Wonder on 15 Feb 2023
US Government payer funded trials to address oncology's drug dosing conundrum: a Congressional call to action?
13 February 2023 - Since the mid 20th century, cancer drug development has been guided by the assumption that more is ...
Posted by Michael Wonder on 24 Jan 2023
Sequential, multiple assignment, randomised trial designs
24 January 2023 - An adaptive intervention is a set of diagnostic, preventive, therapeutic, or engagement strategies that are used in ...
Posted 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 ...