Due to potential concerns of bias and conflicts of interest, regulatory bodies should not do evaluation methodology research related to their regulatory missions

Author:

Chakraborty Dev P.1,Nishikawa Robert M.1,Orton Colin G.

Affiliation:

1. Department of Radiology; University of Pittsburgh; Pittsburgh PA 15213 USA

Publisher

Wiley

Subject

General Medicine

Reference15 articles.

1. Samuelson FW Petrick N Comparing image detection algorithms using resampling 2006 1312 1315

2. FDA/CDRH Guidance for Industry and FDA Staff Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data-Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions 2015 http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm187277.htm

3. Observer studies involving detection and localization: modeling, analysis and validation;Chakraborty;Med Phys,2004

4. Diagnostic performance of digital versus film mammography for breast-cancer screening;Pisano;N Engl J Med,2005

5. The continuing unethical conduct of underpowered clinical trials;Halpern;JAMA,2002

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