Studies Of Prescription Digital Therapeutics Often Lack Rigor And Inclusivity

Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements

(2021) Reshma Ramachandran et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017

(2020) Audrey D. Zhang et al.   JAMA Network Open

Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019

(2020) James L. Johnston et al.   JAMA Internal Medicine

Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011

(2015) Vinay K. Rathi et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Sham Controls in Medical Device Trials

(2014) Rita F. Redberg   NEW ENGLAND JOURNAL OF MEDICINE

Single-Center Trials Show Larger Treatment Effects Than Multicenter Trials: Evidence From a Meta-epidemiologic Study

(2013) Agnes Dechartres et al.   ANNALS OF INTERNAL MEDICINE

Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices

(2009) Sanket S. Dhruva   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Variations Between Clinical Trial Participants and Medicare Beneficiaries in Evidence Used for Medicare National Coverage Decisions

(2008) Sanket S. Dhruva   ARCHIVES OF INTERNAL MEDICINE