Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study

17 January 2020 - Failure to report the results of a clinical trial can distort the evidence base for clinical practice, ...

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Closing the cycle of innovation in health care in Europe

17 January 2020 - Pragmatic or practice-oriented comparative effectiveness trials may be conducted to fill the evidence gaps that are revealed ...

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Incidental imaging findings in clinical trials

13 January 2020 - Clinical trial end points are outcome measures used to assess the efficacy and safety of an ...

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Beyond “Intent‐to‐treat” and “Per protocol”: improving assessment of treatment effects in clinical trials through the specification of an estimand

27 December 2019 - There is a key problem in randomised clinical trials as outcomes can be distorted due to ...

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Strategic need for large prospective studies in different populations

9 December 2019 - Retrospective studies, in which well-characterized individuals with a particular disease are compared with control individuals without the ...

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Adaptive design clinical trials for drugs and biologics guidance for industry

29 November 2019 - This document provides guidance to sponsors and applicants submitting investigational new drug applications, new drug applications, biologics ...

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Watched by Apple

14 November 2019 - After taking over media, social communication, and the consumer economy, the forces of digital innovation are moving ...

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10 year update on study results submitted to ClinicalTrials.gov

14 November 2019 - A decade after ClinicalTrials.gov launched a database for reporting results of clinical trials, the database includes results ...

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Where were the women? Gender parity in clinical trials

30 October 2019 - On October 3, the FDA approved co-formulated tenofovir alafenamide and emtricitabine (F/TAF) for HIV prevention in at-risk ...

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Model assisted designs for early phase clinical trials: simplicity meets superiority

30 October 2019 - Drug development enterprise is struggling because of prohibitively high costs and slow progress.  ...

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Where next for randomised controlled trials in global health?

26 October 2019 - The 2019 Nobel Memorial Prize in Economic Sciences was awarded to three economists—Esther Duflo, Abhijit Bannerjee, and ...

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Older patients (still) left out of cancer clinical trials

24 October 2019 - A decade before he became the US Surgeon General, Vivek Murthy, MD, published a 2004 study in ...

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RWE to supplement RCTs: FDA projects continue

15 October 2019 - The US FDA has been working with several different data and research companies to further its ...

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Canada's decision to make public more clinical trial data puts pressure on FDA

11 October 2019 - Last March, Canada's department of health changed the way it handles the huge amount of data ...

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FDA cuts red tape in diagnosis applications for cancer trials

10 October 2019 - Drug companies developing cancer treatments can fold the risk assessment of unapproved screening tests into their ...

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