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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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, ...

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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.  ...

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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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