CDER conversation: complex innovative trial designs

25 September 2018 - Complex innovative trial designs – including the use of adaptive, Bayesian, and other novel statistical approaches ...

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Cost of clinical trials for new drug FDA approval are fraction of total tab

24 September 2018 - Clinical trials that support FDA approvals of new drugs have a median cost of $19 million, ...

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FDA proposes stiff fines for failing to report clinical trials

20 September 2018 - Pharmaceutical companies could face penalties of up to US$10,000 per day. ...

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Using evidence from randomised controlled trials in economic models: what information is relevant and is there a minimum amount of sample data required to make decisions?

21 September 2018 - Evidence from randomised controlled trials is used to support regulatory approval and reimbursement decisions.  ...

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Harvard Professor's attack on pharma's clinical trials is absurd

18 September 2018 - Dr. Marcia Angell, a senior lecturer at Harvard Medical School and the first woman to serve as ...

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Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource

12 September 2018 - Following the 2012 EC guideline, sponsors must ensure that all trials registered on EUCTR since 2004 disclose ...

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Choice of control group in randomised trials of cancer medicine: are we testing trivialities?

31 August 2018 - Several trials in cancer medicine over the past 5 years share two common features: first, they were ...

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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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