821
Views
21
CrossRef citations to date
0
Altmetric
Articles

Statistical innovations in the medical device world sparked by the FDA

&
Pages 3-16 | Received 17 Aug 2015, Accepted 01 Sep 2015, Published online: 20 Jan 2016

Keep up to date with the latest research on this topic with citation updates for this article.

Read on this site (5)

Wei-Chen Chen, Nelson Lu, Chenguang Wang, Heng Li, Changhong Song, Ram Tiwari, Yunling Xu & Lilly Q. Yue. (2022) Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies. Journal of Biopharmaceutical Statistics 32:3, pages 400-413.
Read now
Wei-Chen Chen, Chenguang Wang, Heng Li, Nelson Lu, Ram Tiwari, Yunling Xu & Lilly Q. Yue. (2020) Propensity score-integrated composite likelihood approach for augmenting the control arm of a randomized controlled trial by incorporating real-world data. Journal of Biopharmaceutical Statistics 30:3, pages 508-520.
Read now
Tinghui Yu, Qin Li, Gerry Gray & Lilly Q. Yue. (2016) Statistical innovations in diagnostic device evaluation. Journal of Biopharmaceutical Statistics 26:6, pages 1067-1077.
Read now

Articles from other publishers (16)

Roberto Gomeni, Françoise Bressolle-Gomeni & Maurizio Fava. (2023) A new method for analyzing clinical trials in depression based on individual propensity to respond to placebo estimated using artificial intelligence. Psychiatry Research 327, pages 115367.
Crossref
Heng Li & Lilly Q. Yue. (2023) Propensity score‐based methods for causal inference and external data leveraging in regulatory settings: From basic ideas to implementation. Pharmaceutical Statistics 22:4, pages 721-738.
Crossref
Roberto Gomeni, Françoise Bressolle-Gomeni & Maurizio Fava. (2023) Artificial intelligence approach for the analysis of placebo-controlled clinical trials in major depressive disorders accounting for individual propensity to respond to placebo. Translational Psychiatry 13:1.
Crossref
Max Waschbusch, Lisa Rodriguez, Andreas Brueckner, Kerry Jo Lee, Xuefeng Li, Oksana Mokliatchouk, Lothar Tremmel & Shuai S. Yuan. (2022) Global Landscape of Benefit–Risk Considerations for Medicinal Products: Current State and Future Directions. Pharmaceutical Medicine 36:4, pages 201-213.
Crossref
Heng Li, Pamela E. Scott & Lilly Q. Yue. 2022. Principles and Practice of Clinical Trials. Principles and Practice of Clinical Trials 1399 1416 .
Stephen Senn. 2021. Statistical Issues in Drug Development. Statistical Issues in Drug Development 9 30 .
Christina D. Mack, Alessandra Pavesio, Kim Kelly, Debra E. Irwin, Greg Maislin, John Jones, Tawana Wester & Robert Zura. (2021) Breaking Barriers: Studying Fracture Healing in the BONES Program. Journal of Orthopaedic Trauma 35:1, pages S22-S27.
Crossref
Heng Li, Pamela E. Scott & Lilly Q. Yue. 2020. Principles and Practice of Clinical Trials. Principles and Practice of Clinical Trials 1 18 .
Lindsay M. Oberman, Shannon Exley, Noah S. Philip, Shan H. Siddiqi, Maheen M. Adamson & David L. Brody. (2020) Use of Repetitive Transcranial Magnetic Stimulation in the Treatment of Neuropsychiatric and Neurocognitive Symptoms Associated With Concussion in Military Populations. Journal of Head Trauma Rehabilitation 35:6, pages 388-400.
Crossref
Tobias N Bonten, Anneloek Rauwerdink, Jeremy C Wyatt, Marise J Kasteleyn, Leonard Witkamp, Heleen Riper, Lisette JEWC van Gemert-Pijnen, Kathrin Cresswell, Aziz Sheikh, Marlies P Schijven & Niels H Chavannes. (2020) Online Guide for Electronic Health Evaluation Approaches: Systematic Scoping Review and Concept Mapping Study. Journal of Medical Internet Research 22:8, pages e17774.
Crossref
Andrew Metcalfe, Elke Gemperle Mannion, Helen Parsons, Jaclyn Brown, Nicholas Parsons, Josephine Fox, Rebecca Kearney, Tom Lawrence, Howard Bush, Kerri McGowan, Iftekhar Khan, James Mason, Charles Hutchinson, Simon Gates, Nigel Stallard, Martin Underwood & Stephen Drew. (2020) Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS). BMJ Open 10:5, pages e036829.
Crossref
Vinayak Smith, Ritesh Warty, Amrish Nair, Sathya Krishnan, Joel Arun Sursas, Fabricio da Silva Costa, Beverley Vollenhoven & Euan Morrison Wallace. (2019) Defining the clinician’s role in early health technology assessment during medical device innovation – a systematic review. BMC Health Services Research 19:1.
Crossref
Bruce Campbell, John Wilkinson, Mirella Marlow & Murray Sheldon. (2019) Generating evidence for new high-risk medical devices. BMJ Surgery, Interventions, & Health Technologies 1:1, pages e000022.
Crossref
Akram Ahangarpour, Soheila Alboghobeish, Ali Akbar Oroojan, Leila Zeidooni, Azin Samimi & Golshan Afshari. (2017) Effects of Combined Exposure to Chronic High-Fat Diet and Arsenic on Thyroid Function and Lipid Profile in Male Mouse. Biological Trace Element Research 182:1, pages 37-48.
Crossref
Gregory Campbell, Heng Li, Gene Pennello & Lilly Q. Yue. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online 1 32 .
Gregory Campbell. (2017) Bayesian methods in clinical trials with applications to medical devices. Communications for Statistical Applications and Methods 24:6, pages 561-581.
Crossref

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.