Blog
RSS FeedPosted 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 05 Mar 2023
Replacing RCTs with real world data for regulatory decision-making: a self-fulfilling prophecy?
2 March 2023 - Real world data are advocated as an alternative approach to randomised clinical trials for closing knowledge gaps ...
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 01 Feb 2023
Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU
31 January 2023 - From 31 January 2023, all initial clinical trial applications in the European Union must be submitted via ...
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 19 Dec 2022
Draft guidance document on the collection and analysis of disaggregated data in clinical trials: transparency
16 December 2022 - This guidance will help sponsors interpret amendments to the Food and Drug Regulations (regulations) requiring them ...
Posted by Michael Wonder on 19 Dec 2022
Facilitating decentralised clinical trials in the EU
19 December 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published recommendations that aim to ...
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 ...