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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EMA launches pilot project on analysis of raw data from clinical trials

12 July 2022 - EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical ...

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A first step towards best practice recommendations for the design and statistical analyses of pragmatic clinical trials: a modified Delphi approach

15 June 2022 - Pragmatic clinical trials are randomised trials implemented through routine clinical practice, where design parameters of traditional randomised ...

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FDA’s treatment of China developed drugs spurs demands for multiregional clinical trials

14 June 2022 - China’s ambition to become a leader in the biopharma industry has been clear in the last ...

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Toward incorporating health-related quality of life as co-primary endpoints in clinical trials: time to achieve clinical important differences and quality of life profiles

16 May 2022 - Besides morbidity and mortality, quality of life is a key outcome of cancer treatments.  ...

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Ethical considerations for the inclusion of patient reported outcomes in clinical research

17 May 2022 - An international consensus Delphi process was developed according to the Enhancing the Quality and Transparency of Health ...

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Basket trials: review of current practice and innovations for future trials

10 May 2022 - Basket trials, one type of master protocol, emerged as a tool for evaluating biomarker-targeted therapies among multiple ...

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Choices that fail health and wellbeing

5 May 2022 - NICE's expert group RAPID C-19, set up to ‘to ensure safe and timely patient access to treatments ...

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