FDA launches new pilot to advance innovative clinical trial designs as part of agency’s broader program to modernise drug development and promote innovation in drugs targeted to unmet needs

29 August 2018 - Today, the U.S. FDA announced a new pilot program (“Complex Innovative Designs Pilot Meeting Program”) in which ...

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Data enclaves for sharing information derived from clinical and administrative data

28 August 2018 - The promise that big data will transform health care has yet to be fulfilled.  ...

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Co-ordinated clinical trials could help more Australians

29 August 2018 - Every year about 1000 clinical trials start in Australia, with cancer the most frequently targeted condition. ...

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FDA says sponsors should limit placebo controlled trials in cancer

23 August 2018 - FDA released draft guidance on Thursday to debunk the notion that FDA requires the use of ...

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FDA analysis shows similar success rates for paediatric trials using clinical and surrogate outcomes

21 August 2018 - An analysis by US FDA officials published earlier this month finds that there is a similar ...

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FDA advances efficient approaches to designing and conducting cancer clinical trials

14 August 2018 - Over the past decade, advances in understanding of cancer biology have led to the development of targeted ...

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MHRA clarifies post-Brexit clinical trials rules

8 August 2018 - The MHRA has clarified how the UK’s clinical trials rules will function in partnership with the ...

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$50 million to provide life-saving support to cancer patients

18 July 2018 - The Australian Government will provide $50 million to support some of Australia’s sickest patients, battling the most ...

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Federal Government to announce $50 million custom cancer drug trial

17 July 2018 - Almost 600 Queenslanders will have their cancer’s DNA tested to identify the drugs that will keep ...

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Bias, operational bias, and generalisability in Phase II/III trials

27 June 2018 - Adaptive clinical trial designs improve the efficiency of the drug development process by allowing treatment decisions to ...

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Finding cancer patients is the pharma industry’s unlikely challenge

20 June 2018 - Doctors will need to test 100 patients to find one candidate. ...

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Effect of cross-over in oncology clinical trials on evidence levels in early benefit assessment in Germany

13 June 2018 - In oncology clinical trials, cross-over is used frequently but may lead to uncertainties regarding treatment effects. ...

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Clinical trial design and dissemination: comprehensive analysis of clinicaltrials.gov and PubMed data since 2005

6 June 2018 - Well conducted clinical trials are widely regarded as the best source of evidence on the efficacy and ...

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Clinical trial participants’ views of the risks and benefits of data sharing

7 June 2018 - Sharing of participant-level clinical trial data has potential benefits, but concerns about potential harms to research participants ...

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Multiplicity considerations in clinical trials

31 May 2018 - Making multiple comparisons increases the likelihood that a chance association could be interpreted as causal.  ...

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