FDA use of “proxies” to expedite drug approvals not supported by evidence, analysis finds

28 May 2024 - In the world of drug development, there has been a recent movement to speed clinical trials of ...

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Associations between surrogate markers and clinical outcomes for non-oncologic chronic disease treatments

22 April 2024 - What is the strength of association between surrogate markers used as primary outcomes in clinical trials ...

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How ‘surrogate outcomes’ influence long-term health outcomes

13 April 2023 - NICE working with international organisations to develop guidance. ...

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You're cured till you're not: should disease-free survival be used as a regulatory or clinical endpoint for adjuvant therapy of cancer?

9 December 2022 - Recent commentary reviewing the use of biologics or other novel molecules tested in the adjuvant setting for ...

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Digital Medicine Society launches toolkit to support reimbursement for new drugs developed using digital outcomes

4 April 2022 - New essential resources ensure that patients will benefit without delay following regulatory acceptance of digital outcomes. ...

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Progression-free survival: it is time for a new name

1 March 2022 - Progression-free survival refers to the time from randomisation or initiation of treatment to the occurrence of disease ...

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Beyond survival: the US FDA confirms surrogate end points for patients with newly diagnosed acute myeloid leukaemia treated with intensive chemotherapy

10 January 2022 - The treatment of acute myeloid leukaemia has rapidly evolved over the past decade.  ...

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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.  ...

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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 ...

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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 ...

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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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