Wallach JD - Search Results

1

Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials.

Wallach JD, Deng Y, Polley EC, Dhruva SS, Herrin J, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Jeffery MM, Lyon TD, Ross JS, McCoy RG. Wallach JD, et al. Clin Trials. 2023 Dec;20(6):689-698. doi: 10.1177/17407745231193137. Epub 2023 Aug 17. Clin Trials. 2023. PMID: 37589143 Free PMC article.

2

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

Wallach JD, Gonsalves GS, Ross JS. Wallach JD, et al. J Clin Epidemiol. 2018 Jan;93:88-93. doi: 10.1016/j.jclinepi.2017.08.021. Epub 2017 Oct 16. J Clin Epidemiol. 2018. PMID: 29042327 No abstract available.

3

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. Egilman AC, et al. Among authors: wallach jd. JAMA Intern Med. 2018 Apr 1;178(4):567-569. doi: 10.1001/jamainternmed.2017.8016. JAMA Intern Med. 2018. PMID: 29340562 Free PMC article.

4

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. Wallach JD, et al. Res Integr Peer Rev. 2018 Jan 5;3:1. doi: 10.1186/s41073-017-0045-8. eCollection 2018. Res Integr Peer Rev. 2018. PMID: 29451557 Free PMC article.

5

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

Wallach JD, Ross JS. Wallach JD, et al. JAMA. 2018 Feb 27;319(8):776-778. doi: 10.1001/jama.2017.21897. JAMA. 2018. PMID: 29486013 No abstract available.

6

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. Wallach JD, et al. BMC Med. 2018 Mar 21;16(1):45. doi: 10.1186/s12916-018-1023-9. BMC Med. 2018. PMID: 29562926 Free PMC article.

7

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. Wallach JD, et al. BMJ. 2018 May 24;361:k2031. doi: 10.1136/bmj.k2031. BMJ. 2018. PMID: 29794072 Free PMC article.

8

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

Wallach JD, Ross JS, Naci H. Wallach JD, et al. Clin Trials. 2018 Jun;15(3):243-246. doi: 10.1177/1740774518770657. Clin Trials. 2018. PMID: 29871507 No abstract available.

9

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

Wallach JD, Ross JS, Naci H. Wallach JD, et al. Clin Trials. 2018 Jun;15(3):219-229. doi: 10.1177/1740774518770648. Clin Trials. 2018. PMID: 29871509

10

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

Puthumana J, Wallach JD, Ross JS. Puthumana J, et al. Among authors: wallach jd. JAMA. 2018 Jul 17;320(3):301-303. doi: 10.1001/jama.2018.7619. JAMA. 2018. PMID: 30027239 Free PMC article.

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