Adjustment for baseline characteristics in randomised clinical trials

17 November 2022 - The purpose of randomisation in clinical trials is to ensure that there are no systematic differences between ...

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FDA finalises multiple endpoints guidance

20 October 2022 - The US FDA on Thursday finalised guidance to sponsors on managing multiple outcomes in clinical trials ...

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New federal incentives for diversity in clinical trials

8 October 2022 - In June 2022, the US House of Representatives passed legislation intended to increase the diversity of ...

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The critical role of academic clinical trials in paediatric cancer drug approvals: design, conduct, and fit for purpose data for positive regulatory decisions

6 October 2022 - For decades, academic clinical trials consortia have collaborated to optimise outcomes for childhood cancers through evaluating incremental ...

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Registry-based randomised trials: the best of both worlds?

15 September 2022 - IQWiG authors present the advantages and disadvantages of study designs that combine explanatory and pragmatic aspects. ...

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Clinical trials: real world data plays early role in efforts to increase diversity

5 September 2022 - The use of real world data to help design clinical trials is nothing new but increasingly it ...

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Accelerating clinical trials in the EU: publication of 2022-2026 workplan

30 August 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published the  2022-2026 workplan ...

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Early phase oncology trials: why so many designs?

12 August 2022 - The past 30 years have seen a considerable effort on the part of statisticians to improve the ...

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Cure Rare Disease receives FDA approval to administer first in human CRISPR therapeutic

10 August 2022 - Cure Rare Disease announces the approval from the US FDA to administer its very first therapeutic.  ...

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U.S. regulators defend requiring more data on monkeypox drug

4 August 2022 - As U.S. monkeypox cases rise, U.S. health agencies in a medical journal article published on Wednesday ...

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Connecting electronic health records to clinical trials: how to embrace the promise of real world data

3 August 2022 - We all know that real world data from electronic health records could boost clinical trial efficiency ...

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Patient reported outcome measures in clinical research

 2 August 2022 - Health conditions may cause patients to feel ill and have impaired functioning in their daily lives. Thus, ...

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Advancing innovative clinical trials to efficiently deliver medicines to patients

1 August 2022 - Complex innovative designs in clinical trials have the potential to increase efficiency and lower the cost of ...

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‘No magic bullet’: For drug makers and the FDA, clinical trials on ultra rare diseases pose thorny challenges

26 July 2022 - Walker Burger is beside himself with worry. ...

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Simulating colorectal cancer trials using real world data

20 July 2022 - Using real world data –based trial simulation approach, we aim to simulate colorectal cancer trials and ...

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