Blog
RSS FeedPosted by Michael Wonder on 19 Sep 2021
Should regulatory authorities approve drugs based on surrogate outcomes?
16 September 2021 - The aducanumab controversy is the latest example of surrogate outcomes failing to predict clinically important outcomes. ...
Posted by Michael Wonder on 16 Sep 2021
Raising the bar for using surrogate outcomes in drug regulation and health technology assessment
16 September 2021 - Surrogate outcomes provide no guarantee of clinical benefit, and Dalia Dawoud and colleagues argue they should ...
Posted by Michael Wonder on 10 Aug 2021
Final guidance on metastasis-free survival in non-metastatic castration resistant prostate cancer released by the FDA
10 August 2021 - The FDA announced its finalised guidance on the use of metastases-free survival as an outcome for ...
Posted by Michael Wonder on 22 Feb 2021
Clinical relevance of patient-reported outcomes: new threshold proves to be practical
18 February 2021 - Current examples show that the 15% threshold newly set by IQWiG for the recognition of responder analyses ...
Posted by Michael Wonder on 14 Dec 2020
Public posting of a comprehensive surrogate endpoint table for CDER and CBER regulated products
11 December 2020 - The public posting of a surrogate endpoint table for both reasonably likely and validated surrogate outcomes was ...
Posted by Michael Wonder on 11 Sep 2020
Surrogate outcomes in health technology assessment: an international review of methodological guidelines
11 September 2020 - In the drive towards faster patient access to treatments, health technology assessment agencies are increasingly faced with ...
Posted by Michael Wonder on 31 Jul 2020
Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable outcomes for clinical trials
31 July 2020 - International regulators have published a report today on the acceptability of various primary outcomes in the ...
Posted by Michael Wonder on 30 Jul 2020
Pathological complete response in neo-adjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval
29 July 2020 - This guidance is intended to assist sponsors in designing trials to support marketing approval of medicines and ...
Posted by Michael Wonder on 14 Apr 2020
Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs
13 April 2020 - In July 2018, the FDA first published a table listing all surrogate measures that it has used, ...
Posted by Michael Wonder on 28 Feb 2020
When can intermediate outcomes be used as surrogate outcomes?
27 February 2020 - Randomised clinical trials have a long history of success in many medical arenas. ...
Posted by Michael Wonder on 14 Nov 2019
Researchers call on FDA to rethink guidance allowing use of surrogate outcomes
13 November 2019 - The US FDA needs to reconsider its use of surrogate outcomes in some guidance documents on ...
Posted by Michael Wonder on 11 Sep 2019
The use of validated and non-validated surrogate endpoints in two EMA expedited approval pathways: A cross-sectional study of products authorised 2011–2018
10 September 2019 - In situations of unmet medical need or in the interests of public health, expedited approval pathways, ...
Posted by Michael Wonder on 26 Jul 2019
Surrogate endpoints in randomised controlled trials: a reality check
27 July 2019 - At the 24th Congress of the European Hematology Association in June, 2019, the results of the BELLINI ...
Posted by Michael Wonder on 24 Jul 2019
FDA seeks input on biomarker, endpoint glossary
24 July 2019 - Two-and-a-half years after its release, the US FDA is asking for input from the public on ...
Posted by Michael Wonder on 09 Apr 2019
Minimal residual disease as a surrogate outcome for product development for multiple myeloma: comparing FDA and EMA guidances
8 April 2019 - This article discusses the need to update regulatory science to include the use of minimal residual disease ...