Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 17 Jan 2019
FDA updates guidance on development of rare disease therapies
17 January 2019 - The FDA has revised its draft guidance for developing rare disease treatments to include the use ...
Posted by Michael Wonder on 19 Dec 2018
FDA advances new scientific framework to promote greater predictability, efficiency in oncology drug development
19 December 2018 - Today, the U.S. FDA issued guidance, Clinical Trial Endpoints for the Approval of Cancer Drugs and ...
Posted by Michael Wonder on 12 Dec 2018
Metastasis-free survival in prostate cancer: faster drug approvals, better drugs?
12 December 2018 - On 13 February 2018, the US FDA granted marketing authorisation to apalutamide for treatment of non-metastatic castration-resistant ...
Posted by Michael Wonder on 16 Oct 2018
FDA guides on minimal residual disease endpoint in haematologic cancer trials
16 October 2018 - FDA Commissioner Scott Gottlieb highlighted minimal residual disease's potential as a surrogate endpoint in clinical trials ...
Posted by Michael Wonder on 05 Oct 2018
Evaluating progression-free survival as a surrogate outcome for health-related quality of life in oncology
1 October 2018 - Progression-free survival has become a commonly used outcome to assess the efficacy of new cancer drugs. However, ...
Posted by Michael Wonder on 10 Sep 2018
Endocyte announces FDA acceptance of radiographic progression free survival as an alternative primary endpoint of the VISION trial in addition to overall survival
10 September 2018 - Demonstrating benefit in rPFS versus control, with no detriment to OS, sufficient for full approval. ...
Posted by Michael Wonder on 21 Aug 2018
FDA analysis shows similar success rates for paediatric trials using clinical and surrogate outcomes
21 August 2018 - An analysis by US FDA officials published earlier this month finds that there is a similar ...
Posted by Michael Wonder on 25 Jul 2018
FDA publishes list of surrogate outcomes used in drug approvals
25 July 2018 - The US FDA on Wednesday published a list of surrogate outcomes to help inform drug developer ...
Posted by Michael Wonder on 11 Jul 2018
Challenges and methodologies in using progression free survival as a surrogate for overall survival in oncology
11 July 2018 - A primary outcome in oncology trials is overall survival. However, to estimate overall survival accurately requires ...
Posted by Michael Wonder on 29 Jul 2017
Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?
26 July 2017 - Surrogate outcomes are not intrinsically beneficial to patients, but are designed to be easier and faster to ...
Posted by Michael Wonder on 22 Mar 2017
The role of imperfect surrogate endpoint information in drug approval and reimbursement decisions
22 March 2017 - Weakly correlated surrogates encourage payers and regulators to impose more stringent evidence thresholds. ...