Published Research By Topic

Transparency: Trial Registration and Results Reporting

Chen, R., N. R. Desai, J. S. Ross, W. Zhang, K. H. Chau, B. Wayda, K. Murugiah, D. Y. Lu, A. Mittal and H. M. Krumholz (2016). "Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers." BMJ 352: i637.

Dal-Re, R., J. S. Ross and A. Marusic (2016). "Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting." J Clin Epidemiol 75: 100-107.

Phillips, A. T., V. K. Rathi and J. S. Ross (2016). "Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study." JAMA Intern Med 176(4): 551-552.

Transparency: Clinical Trial Data Sharing

Iqbal, S. A., J. D. Wallach, M. J. Khoury, S. D. Schully and J. P. Ioannidis (2016). "Reproducible Research Practices and Transparency across the Biomedical Literature." PLoS Biol 14(1): e1002333.

Krumholz, H. M. and J. Kim (2017). "Data Escrow and Clinical Trial Transparency." Ann Intern Med 166(12): 893-894.

Krumholz, H. M. and J. Waldstreicher (2016). "The Yale Open Data Access (YODA) Project--A Mechanism for Data Sharing." N Engl J Med 375(5): 403-405.

Murugiah, K., J. D. Ritchie, N. R. Desai, J. S. Ross and H. M. Krumholz (2016). "Availability of Clinical Trial Data From Industry-Sponsored Cardiovascular Trials." J Am Heart Assoc 5(4): e003307.

Ross, J. S. (2016). "Making Data Submitted to the Food and Drug Administration More Visible." JAMA Intern Med 176(2): 259.

Ross, J. S. and H. M. Krumholz (2016). "Open Access Platforms for Sharing Clinical Trial Data." JAMA 316(6): 666.

Ross, J. S., J. D. Ritchie, E. Finn, N. R. Desai, R. L. Lehman, H. M. Krumholz and C. P. Gross (2016). "Data sharing through an NIH central database repository: a cross-sectional survey of BioLINCC users." BMJ Open 6(9): e012769.

Research Integrity and Medical Product Regulation

Barbour, V., D. Burch, F. Godlee, C. Heneghan, R. Lehman, R. Perera, J. S. Ross and S. Schroter (2016). "Characterisation of trials where marketing purposes have been influential in study design: a descriptive study." Trials 17: 31.

Chavalarias, D., J. D. Wallach, A. H. Li and J. P. Ioannidis (2016). "Evolution of Reporting P Values in the Biomedical Literature, 1990-2015." JAMA 315(11): 1141-1148.

Downing, N. S., N. D. Shah, J. H. Neiman, J. A. Aminawung, H. M. Krumholz and J. S. Ross (2016). "Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals." Trials 17: 199.

Wallach, J. D. and S. Basu (2016). "Commentary: The challenge of evaluating and improving evidence when research lacks reproducibility." Int J Epidemiol 45(6): 2171-2172.

Wallach, J. D., P. G. Sullivan, J. F. Trepanowski, K. L. Sainani, E. W. Steyerberg and J. P. Ioannidis (2017). "Evaluation of Evidence of Statistical Support and Corroboration of Subgroup Claims in Randomized Clinical Trials." JAMA Intern Med 177(4): 554-560.

Wallach, J. D., P. G. Sullivan, J. F. Trepanowski, E. W. Steyerberg and J. P. Ioannidis (2016). "Sex based subgroup differences in randomized controlled trials: empirical evidence from Cochrane meta-analyses." BMJ 355: i5826.

Regulatory Research

Chen, S. I., E. R. Fox, M. K. Hall, J. S. Ross, E. M. Bucholz, H. M. Krumholz and A. K. Venkatesh (2016). "Despite Federal Legislation, Shortages Of Drugs Used In Acute Care Settings Remain Persistent And Prolonged." Health Aff (Millwood) 35(5): 798-804.

Dhruva, S. S., N. R. Desai, P. Karaca-Mandic, N. D. Shah and J. S. Ross (2017). "Medicare Formulary Changes After the 2013 American College of Cardiology/American Heart Association Cholesterol Guideline." J Am Coll Cardiol 69(2): 244-246.

Dhruva, S. S. and R. F. Redberg (2017). "FDA Drug Trials Snapshots-A Clearer Picture." JAMA Intern Med 177(5): 727.

Downing, N. S., N. D. Shah, J. A. Aminawung, A. M. Pease, J. D. Zeitoun, H. M. Krumholz and J. S. Ross (2017). "Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010." JAMA 317(18): 1854- 1863.

Downing, N. S., A. D. Zhang and J. S. Ross (2017). "Regulatory Review of New Therapeutic Agents - FDA versus EMA, 2011-2015." N Engl J Med 376(14): 1386-1387.

Gopal, A. D., V. K. Rathi, C. C. Teng, L. V. Del Priore and J. S. Ross (2017). "Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979-2015." Ophthalmology.

Greenway, T. and J. S. Ross (2017). "US drug marketing: how does promotion correspond with health value?" BMJ 357: j1855.

Gupta, R., A. S. Kesselheim, N. Downing, J. Greene and J. S. Ross (2016). "Generic Drug Approvals Since the 1984 Hatch-Waxman Act." JAMA Intern Med 176(9): 1391-1393.

Gupta, R., A. S. Kesselheim and J. S. Ross (2017). "Prioritization of Generic Drug Review- Reply." JAMA Intern Med 177(1): 141-142.

Kapczynski, A. (2016). "Free Speech and Pharmaceutical Regulation -- Fishy Business." JAMA Intern Med 176(3): 295-296.

Kim, J. and A. Kapczynski (2017). "Promotion of Drugs for Off-label Uses: The US Food and Drug Administration at a Crossroads." JAMA Intern Med 177(2): 157-158.

Pease, A. M., H. M. Krumholz, N. S. Downing, J. A. Aminawung, N. D. Shah and J. S. Ross (2017). "Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review." BMJ 357: j1680.

Rathi, V. K., A. S. Kesselheim and J. S. Ross (2016). "The US Food and Drug Administration 515 Program Initiative: Addressing the Evidence Gap for Widely Used, High-Risk Cardiovascular Devices?" JAMA Cardiol 1(2): 117-118.

Rathi, V. K., H. M. Krumholz and J. S. Ross (2016). "Commentary: Diagnostic devices in clinical trials have high stakes for patient care." BMJ 354: i5197.

Zeitoun, J. D., J. H. Lefevre, N. S. Downing, H. Bergeron and J. S. Ross (2016). "Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study." Pharmacoepidemiol Drug Saf 25(6): 687-694.

Medical Product Pricing

Beckman, A. L., A. Bilinski, R. Boyko, G. M. Camp, A. T. Wall, J. K. Lim, E. A. Wang, R. D. Bruce and G. S. Gonsalves (2016). "New Hepatitis C Drugs Are Very Costly And Unavailable To Many State Prisoners." Health Affairs 35(10): 1893-1901.

Brennan, H., A. Kapczynski, C. H. Monahan and Z. Rizvi (2016). "A Prescription for Excessive Drug Pricing: Leveraging Government Patent Use for Health." Yale Journal of Law & Technology 8: 275-353.

Kapczynski, A. and A. S. Kesselheim (2016). "‘Government Patent Use’: A Legal Approach To Reducing Drug Spending." Health Affairs 35(5): 791-797.

For a complete list of faculty publications on other topics, please visit the affiliated faculty members' profiles.

Gregg Gonsalves

Amy Kapczynski 

Harlan Krumholz

Joseph Ross

David Schulz