Use of real world evidence to support FDA approval of oncology drugs

8 October 2020 - Real world evidence has gained increased attention in recent years as a complement to traditional clinical trials.  ...

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Demystifying the estimand framework: a case study using patient-reported outcomes in oncology

1 October 2020 - Patient-reported outcome measures describe how a patient feels or functions and are increasingly being used in benefit–risk ...

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Five predictions for AI and real world data in oncology

14 August 2018 - As progress in oncology care is advancing faster than ever -- especially due to the work ...

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FDA officials call for including adolescents in adult oncology trials

20 December 2016 - A team of officials at the US FDA are calling for a "culture shift" by drug ...

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Bristol-Myers Squibb’s Opdivo (nivolumab) receives breakthrough therapy designation from U.S. Food and Drug Administration for advanced renal cell carcinoma

16 September 2015 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy ...

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