| Original language | English (US) |
|---|---|
| Pages (from-to) | 119-122 |
| Number of pages | 4 |
| Journal | Clinical Trials |
| Volume | 19 |
| Issue number | 1 |
| DOIs | |
| State | Published - Feb 2022 |
ASJC Scopus subject areas
- Pharmacology
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In: Clinical Trials, Vol. 19, No. 1, 02.2022, p. 119-122.
Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Clinical studies sponsored by digital health companies participating in the FDA’s Precertification Pilot Program
T2 - A cross-sectional analysis
AU - Bartlett, Victoria L.
AU - Dhruva, Sanket S.
AU - Shah, Nilay D.
AU - Ross, Joseph S.
N1 - Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: S.S.D. currently receives research support from the National Heart, Lung, and Blood Institute of the National Institute of Health (K12HL138046), Food and Drug Administration, National Evaluation System for health Technology, Arnold Ventures, and the Greenwall Foundation. J.S.R. formerly received research support through Yale University from Medtronic, Inc. and the Food and Drug Administration (FDA) to develop methods for postmarket surveillance of medical devices (U01FD004585), from the Centers of Medicare and Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting (HHSM-500-2013-13018I), and from the Blue Cross Blue Shield Association to better understand medical technology evaluation; J.S.R. currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and to establish the Collaboration for Research Integrity and Transparency (CRIT) at Yale. In the past 36 months, N.D.S. has received research from the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative (TCPI), from the Agency for Healthcare Research and Quality (R01HS025164; R01HS025402; 1U19HS024075; R03HS025517), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R56HL130496; R01HL131535), National Science Foundation, and from the Patient-Centered Outcomes Research Institute (PCORI) to develop a Clinical Data Research Network (LHSNet).
PY - 2022/2
Y1 - 2022/2
UR - http://www.scopus.com/inward/record.url?scp=85117157521&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85117157521&partnerID=8YFLogxK
U2 - 10.1177/17407745211048493
DO - 10.1177/17407745211048493
M3 - Article
C2 - 34632824
AN - SCOPUS:85117157521
SN - 1740-7745
VL - 19
SP - 119
EP - 122
JO - Clinical Trials
JF - Clinical Trials
IS - 1
ER -