Wallach JD - Search Results

1

Consistency between trials presented at conferences, their subsequent publications and press releases.

Rowhani-Farid A, Hong K, Grewal M, Reynolds J, Zhang AD, Wallach JD, Ross JS. Rowhani-Farid A, et al. Among authors: wallach jd. BMJ Evid Based Med. 2023 Apr;28(2):95-102. doi: 10.1136/bmjebm-2022-111989. Epub 2022 Nov 10. BMJ Evid Based Med. 2023. PMID: 36357160 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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