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Statistics in Medicine|September 27, 2002
Industry perspectives on ICH guidelinesFrank W Rockhold
Journal of the American Medical Informatics Association : JAMIA|February 7, 2020
Design and analytic considerations for using patient-reported health data in pragmatic clinical trials: report from an NIH Collaboratory roundtableFrank W Rockhold, Jessica D Tenenbaum, Rachel Richesson, et al.
Clinical and Translational Science|September 8, 2025
Decentralized Clinical Trials in the Era of Real-World Evidence: A Critical Assessment of Recent ExperiencesHongwei Wang, Nadia Daizadeh, Yuan-Li Shen, et al.
Journal of the American College of Cardiology|August 20, 2021
Primary and Secondary Outcome Reporting in Randomized Trials: JACC State-of-the-Art ReviewStuart J Pocock, Xavier Rossello, Ruth Owen, et al.
Therapeutic Innovation & Regulatory Science|June 20, 2020
A Framework for Safety Evaluation Throughout the Product Development Life-CycleGreg Ball, Tjark Reblin, James Buchanan, et al.
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology|June 25, 2024
Clinical Study Report and Individual Participant Data Transparency for US Food and Drug Administration-Approved Anticancer Drugs: A Call for Systematic Data AvailabilityNatansh D Modi, Sandra M Swain, Marc Buyse, et al.
BMJ Open|July 29, 2022
Exploratory analyses of clinical trial data used for health technology assessments: a retrospective evaluationBjörn J Oddens, Israel T Agaku, Ellen S Snyder, et al.
BMJ (Clinical Research Ed.)|June 10, 2022
Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysisRebecca J Williams, Heather D Dobbins, Tony Tse, et al.
Clinical and Translational Science|February 19, 2025
Decentralized Clinical Trials in the Era of Real-World Evidence: A Statistical PerspectiveJie Chen, Junrui Di, Nadia Daizadeh, et al.
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