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Items: 1 to 50 of 348

1.

Evidence supporting FDA approval and CMS national coverage determinations for novel medical products, 2005 through 2016: A cross-sectional study.

Roginiel AC, Dhruva SS, Ross JS.

Medicine (Baltimore). 2018 Oct;97(40):e12715. doi: 10.1097/MD.0000000000012715.

2.

Clinical Trials-We Get What We Pay For.

Ross JS.

JAMA Intern Med. 2018 Sep 24. doi: 10.1001/jamainternmed.2018.3930. [Epub ahead of print] No abstract available.

PMID:
30264093
3.

Will research preprints improve healthcare for patients?

Krumholz HM, Ross JS, Otto CM.

BMJ. 2018 Sep 24;362:k3628. doi: 10.1136/bmj.k3628. No abstract available.

PMID:
30249719
4.

State-Level Population Estimates of Individuals Subject to and Not Meeting Proposed Medicaid Work Requirements.

Silvestri DM, Holland ML, Ross JS.

JAMA Intern Med. 2018 Sep 10. doi: 10.1001/jamainternmed.2018.4196. [Epub ahead of print] No abstract available.

PMID:
30208409
5.
6.

Real-World Evidence: Promise and Peril For Medical Product Evaluation.

Dhruva SS, Ross JS, Desai NR.

P T. 2018 Aug;43(8):464-472.

7.

Trends in opioid use in commercially insured and Medicare Advantage populations in 2007-16: retrospective cohort study.

Jeffery MM, Hooten WM, Henk HJ, Bellolio MF, Hess EP, Meara E, Ross JS, Shah ND.

BMJ. 2018 Aug 1;362:k2833. doi: 10.1136/bmj.k2833.

8.

Medicare Beneficiary Out-of-Pocket Costs for Generic Cardiovascular Medications Available Through $4 Generic Drug Discount Programs.

Liu P, Dhruva SS, Shah ND, Ross JS.

Ann Intern Med. 2018 Jul 24. doi: 10.7326/M18-0965. [Epub ahead of print] No abstract available.

PMID:
30039170
9.
10.

Off-label Use of Medications-Reply.

Wallach JD, Ross JS.

JAMA. 2018 Jul 17;320(3):307-308. doi: 10.1001/jama.2018.6521. No abstract available.

PMID:
30027247
11.

Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation.

Puthumana J, Wallach JD, Ross JS.

JAMA. 2018 Jul 17;320(3):301-303. doi: 10.1001/jama.2018.7619. No abstract available.

PMID:
30027239
12.

Patterns and predictors of off-label prescription of psychiatric drugs.

Vijay A, Becker JE, Ross JS.

PLoS One. 2018 Jul 19;13(7):e0198363. doi: 10.1371/journal.pone.0198363. eCollection 2018.

13.

Early Experiences With Journal Data Sharing Policies: A Survey of Published Clinical Trial Investigators.

Tannenbaum S, Ross JS, Krumholz HM, Desai NR, Ritchie JD, Lehman R, Gamble GM, Bachand J, Schroter S, Groves T, Gross CP.

Ann Intern Med. 2018 Oct 16;169(8):586-588. doi: 10.7326/M18-0723. Epub 2018 Jul 17. No abstract available.

PMID:
30014127
14.

Disparities in the Use of Programmed Death 1 Immune Checkpoint Inhibitors.

O'Connor JM, Seidl-Rathkopf K, Torres AZ, You P, Carson KR, Ross JS, Gross CP.

Oncologist. 2018 Jul 16. pii: theoncologist.2017-0673. doi: 10.1634/theoncologist.2017-0673. [Epub ahead of print]

PMID:
30012876
15.

The Open Translational Science in Schizophrenia (OPTICS) project: an open-science project bringing together Janssen clinical trial and NIMH data.

Wilcox MA, Savitz AJ, Addington AM, Gray GS, Guinan EC, Jackson JW, Lehner T, Normand SL, Ranu H, Senthil G, Spertus J, Valeri L, Ross JS.

NPJ Schizophr. 2018 Jun 27;4(1):14. doi: 10.1038/s41537-018-0055-7. Review.

16.

Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators.

Bates J, Parzynski CS, Dhruva SS, Coppi A, Kuntz R, Li SX, Marinac-Dabic D, Masoudi FA, Shaw RE, Warner F, Krumholz HM, Ross JS.

Pharmacoepidemiol Drug Saf. 2018 Aug;27(8):848-856. doi: 10.1002/pds.4565. Epub 2018 Jun 12.

PMID:
29896873
17.

The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.

Wallach JD, Ross JS, Naci H.

Clin Trials. 2018 Jun;15(3):219-229. doi: 10.1177/1740774518770648.

PMID:
29871509
18.

The US Food and Drug Administration's expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation.

Wallach JD, Ross JS, Naci H.

Clin Trials. 2018 Jun;15(3):243-246. doi: 10.1177/1740774518770657. No abstract available.

PMID:
29871507
19.

Fulfilling the Promise of Unique Device Identifiers.

Dhruva SS, Ross JS, Schulz WL, Krumholz HM.

Ann Intern Med. 2018 Aug 7;169(3):183-185. doi: 10.7326/M18-0526. Epub 2018 Jun 5. No abstract available.

PMID:
29868760
20.

Network Optimization And The Continuity Of Physicians In Medicaid Managed Care.

Ndumele CD, Staiger B, Ross JS, Schlesinger MJ.

Health Aff (Millwood). 2018 Jun;37(6):929-935. doi: 10.1377/hlthaff.2017.1410.

PMID:
29863934
21.

Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials.

O'Connor JM, Fessele KL, Steiner J, Seidl-Rathkopf K, Carson KR, Nussbaum NC, Yin ES, Adelson KB, Presley CJ, Chiang AC, Ross JS, Abernethy AP, Gross CP.

JAMA Oncol. 2018 Aug 1;4(8):e180798. doi: 10.1001/jamaoncol.2018.0798. Epub 2018 Aug 9.

PMID:
29800974
22.

Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis.

Wallach JD, Egilman AC, Dhruva SS, McCarthy ME, Miller JE, Woloshin S, Schwartz LM, Ross JS.

BMJ. 2018 May 24;361:k2031. doi: 10.1136/bmj.k2031.

23.

Review of clinical trial settings of drugs commonly used in primary care and approved between 2005 and 2012.

Crossley JR, Tan TP, Smith KH, Ross JS, Merenstein DJ.

J Gen Intern Med. 2018 Sep;33(9):1431-1432. doi: 10.1007/s11606-018-4486-7. No abstract available.

PMID:
29777429
24.

Publication and Dissemination of Results in Clinical Trials of Neurology.

Sreekrishnan A, Mampre D, Ormseth C, Miyares L, Leasure A, Ross JS, Sheth KN.

JAMA Neurol. 2018 Jul 1;75(7):890-891. doi: 10.1001/jamaneurol.2018.0674. No abstract available.

PMID:
29710083
25.

The Impact of Off-Patent Drug Acquisitions on Prices.

Gupta R, Henkel A, Forman HP, Ross JS.

J Gen Intern Med. 2018 Jul;33(7):1007-1009. doi: 10.1007/s11606-018-4372-3. No abstract available.

PMID:
29687433
26.

Older drugs with infantile evidence: the illustrative example of loop diuretics.

Bikdeli B, Testani JM, Ross JS, Krumholz HM.

Eur Heart J Qual Care Clin Outcomes. 2018 Jul 1;4(3):232-234. doi: 10.1093/ehjqcco/qcy012. No abstract available.

PMID:
29617967
27.

National Prescribing Trends for High-Risk Anticholinergic Medications in Older Adults.

Rhee TG, Choi YC, Ouellet GM, Ross JS.

J Am Geriatr Soc. 2018 Jul;66(7):1382-1387. doi: 10.1111/jgs.15357. Epub 2018 Mar 26.

PMID:
29582410
28.

Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study.

Wallach JD, Ciani O, Pease AM, Gonsalves GS, Krumholz HM, Taylor RS, Ross JS.

BMC Med. 2018 Mar 21;16(1):45. doi: 10.1186/s12916-018-1023-9.

29.

Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.

Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS.

BMJ. 2018 Mar 19;360:k831. doi: 10.1136/bmj.k831.

30.

Gabapentin Approvals, Off-Label Use, and Lessons for Postmarketing Evaluation Efforts.

Wallach JD, Ross JS.

JAMA. 2018 Feb 27;319(8):776-778. doi: 10.1001/jama.2017.21897. No abstract available.

PMID:
29486013
31.

Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines.

Klara K, Kim J, Ross JS.

J Gen Intern Med. 2018 May;33(5):651-658. doi: 10.1007/s11606-017-4274-9. Epub 2018 Feb 26.

PMID:
29484575
32.

Biomedical journal speed and efficiency: a cross-sectional pilot survey of author experiences.

Wallach JD, Egilman AC, Gopal AD, Swami N, Krumholz HM, Ross JS.

Res Integr Peer Rev. 2018 Jan 5;3:1. doi: 10.1186/s41073-017-0045-8. eCollection 2018.

33.

Factors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis.

Zeitoun JD, Ross JS, Atal I, Vivot A, Downing NS, Baron G, Ravaud P.

Clin Pharmacol Ther. 2018 Jan 29. doi: 10.1002/cpt.1038. [Epub ahead of print]

PMID:
29377075
34.

Bringing Vioxx back to market.

Ross JS, Krumholz HM.

BMJ. 2018 Jan 25;360:k242. doi: 10.1136/bmj.k242. No abstract available.

PMID:
29371221
35.

Statewide Inferior Vena Cava Filter Placement, Complications, and Retrievals: Epidemiology and Recent Trends.

Charalel RA, Durack JC, Mao J, Ross JS, Meltzer AJ, Sedrakyan A.

Med Care. 2018 Mar;56(3):260-265. doi: 10.1097/MLR.0000000000000867.

PMID:
29356721
36.

Medicare Spending and Potential Savings on Brand-Name Drugs With Available Generic Substitutes Excluded by 2 Large Pharmacy Benefit Managers, 2012 Through 2015.

Egilman AC, Wallach JD, Ross JS, Dhruva SS.

JAMA Intern Med. 2018 Apr 1;178(4):567-569. doi: 10.1001/jamainternmed.2017.8016. No abstract available.

PMID:
29340562
37.

Variation in the Diagnosis of Aspiration Pneumonia and Association with Hospital Pneumonia Outcomes.

Lindenauer PK, Strait KM, Grady JN, Ngo CK, Parisi ML, Metersky M, Ross JS, Bernheim SM, Dorsey K.

Ann Am Thorac Soc. 2018 May;15(5):562-569. doi: 10.1513/AnnalsATS.201709-728OC.

PMID:
29298090
38.

Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study.

Zeitoun JD, Ross JS, Atal I, Vivot A, Downing NS, Baron G, Ravaud P.

BMJ Open. 2017 Dec 21;7(12):e018587. doi: 10.1136/bmjopen-2017-018587.

39.

Defining Multiple Chronic Conditions for Quality Measurement.

Drye EE, Altaf FK, Lipska KJ, Spatz ES, Montague JA, Bao H, Parzynski CS, Ross JS, Bernheim SM, Krumholz HM, Lin Z.

Med Care. 2018 Feb;56(2):193-201. doi: 10.1097/MLR.0000000000000853.

PMID:
29271820
40.

Data Sharing and Cardiology: Platforms and Possibilities.

Dey P, Ross JS, Ritchie JD, Desai NR, Bhavnani SP, Krumholz HM.

J Am Coll Cardiol. 2017 Dec 19;70(24):3018-3025. doi: 10.1016/j.jacc.2017.10.037. Review.

PMID:
29241491
41.

New and incremental FDA black box warnings from 2008 to 2015.

Solotke MT, Dhruva SS, Downing NS, Shah ND, Ross JS.

Expert Opin Drug Saf. 2018 Feb;17(2):117-123. doi: 10.1080/14740338.2018.1415323. Epub 2017 Dec 17.

42.

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.

Miller JE, Wilenzick M, Ritcey N, Ross JS, Mello MM.

BMJ Open. 2017 Dec 5;7(12):e017917. doi: 10.1136/bmjopen-2017-017917.

43.

Physician Denial of Inappropriate Patient Requests-What If I Say No??

Ross JS.

JAMA Intern Med. 2018 Jan 1;178(1):92. doi: 10.1001/jamainternmed.2017.7367. No abstract available.

PMID:
29181540
44.

High Costs of FDA Approval for Formerly Unapproved Marketed Drugs.

Hakim A, Gupta R, Ross JS.

JAMA. 2017 Dec 12;318(22):2181-2182. doi: 10.1001/jama.2017.16481. No abstract available.

PMID:
29131905
45.

Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS.

Kim J, Ross JS, Kapczynski A.

JAMA. 2018 Jan 2;319(1):21-22. doi: 10.1001/jama.2017.16477. No abstract available.

PMID:
29117365
46.

Association between FDA black box warnings and Medicare formulary coverage changes.

Dhruva SS, Karaca-Mandic P, Shah ND, Shaw DL, Ross JS.

Am J Manag Care. 2017 Sep 1;23(9):e310-e315.

47.

Medicare Formulary Coverage Restrictions for Prescription Opioids, 2006 to 2015.

Samuels EA, Ross JS, Dhruva SS.

Ann Intern Med. 2017 Dec 19;167(12):895-896. doi: 10.7326/M17-1823. Epub 2017 Oct 10. No abstract available.

PMID:
29052693
48.

Research, regulatory, and clinical decision-making: the importance of scientific integrity.

Wallach JD, Gonsalves GS, Ross JS.

J Clin Epidemiol. 2018 Jan;93:88-93. doi: 10.1016/j.jclinepi.2017.08.021. Epub 2017 Oct 16. No abstract available.

PMID:
29042327
49.

Characteristics of Novel Therapeutics and Postmarket Safety Events-Reply.

Downing NS, Shah ND, Ross JS.

JAMA. 2017 Sep 19;318(11):1067-1068. doi: 10.1001/jama.2017.11517. No abstract available.

PMID:
28975302
50.

Age Differences in Hospital Mortality for Acute Myocardial Infarction: Implications for Hospital Profiling.

Dharmarajan K, McNamara RL, Wang Y, Masoudi FA, Ross JS, Spatz EE, Desai NR, de Lemos JA, Fonarow GC, Heidenreich PA, Bhatt DL, Bernheim SM, Slattery LE, Khan YM, Curtis JP.

Ann Intern Med. 2017 Oct 17;167(8):555-564. doi: 10.7326/M16-2871. Epub 2017 Sep 26.

PMID:
28973634

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