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 ...

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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, ...

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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 ...

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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 ...

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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 ...

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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17 January 2019 - The FDA has revised its draft guidance for developing rare disease treatments to include the use ...

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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 ...

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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 ...

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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 ...

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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, ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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