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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Supporting innovation in Medicaid policy - interventions to increase adoption of RCTs

7 May 2022 - Randomised, controlled trials remain underutilised within the Medicaid program, even though state Medicaid programs regularly implement new ...

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Patient reported outcome assessment must be inclusive and equitable

5 May 2022 - Patient reported outcomes are increasingly collected in clinical trials and in routine clinical practice, but strategies ...

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Are high cost prescription drugs the price of innovation? Disclose the costs of clinical trials.

21 April 2022 - With 40% of Americans struggling to afford prescription medicines and many rationing or delaying initiation of lifesaving ...

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FDA takes important steps to increase racial and ethnic diversity in clinical trials

13 April 2022 - Agency’s focus on inclusion in trials for all medical products aligns with Biden Administration’s cancer moonshot goal ...

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Drug trials a ‘ticking time bomb’: ex-TGA agent

28 March 2022 - A former TGA official who led the regulator’s inspections program has warned that a lack of ...

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Australian cancer patients to get improved access to clinical trials

17 March 2022 - Australian cancer patients will get improved access to local clinical trials through a new public-private partnership ...

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Biosimilar impact on oncology clinical trial design and operations

11 March 2022 - There is a wealth of data, reviews, articles, and regulatory guidance on how to conduct clinical trials ...

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FDA effort to improve clinical trial diversity failed to make a difference for Black patients, study finds

7 March 2022 - Six years ago, the U.S. FDA launched a five year action plan to improve the diversity and ...

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Medicines Australia welcomes reform efforts to speed up clinical trials

4 March 2022 - Australian patients will have improved access to clinical trials due to reforms to be introduced by ...

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