What Evidence is Essential for New Medical Products?
Implications for Patients and Health Policy
June 13, 2014
Bibliography of Key Articles
Ardaugh B, Graves S, Redberg RF. The 510(k) ancestry of a metal-on-metal hip implant. New England Journal of Medicine 2013;368:97-100.
Avorn J. Approval of a tuberculosis drug based on a paradoxical surrogate measure. JAMA 2013;309(13):1349-1350.
Avorn J. Evaluating drug effects in the post-Vioxx world: there must be a better way. Circulation 2006;113(18):2173-2176.
Broder S. The development of antiretroviral therapy and its impact on the HIV-1/AIDS pandemic. Antiviral Research 2010;85(1):1-18.
Carpenter D, Chattopadhyay J, Moffitt S, Nall C. The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety. American Journal of Political Science 2012;56(1):98-114
Connor EM, Smoyer WE, Davis JM, Zajicek A, Ulrich L, Purucker M, Hirschfeld S. Meeting the demand for pediatric clinical trials. Science Translational Medicine 2014;6(227):227fs11.
Darrow JD, Avorn J, Kesselheim AS. New FDA breakthrough-drug category—implications for patients. New England Journal of Medicine 2014;370:1252-1258.
Dhruva SS, Bero LA, Redberg RF. Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices. Circ Cardiovasc Qual Outcomes 2011;4(2):165-71.
Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA 2009;302(24):2679-2685.
Djulbegovic B, Hozo I, Ioannidis JP. Improving the drug development process: more not less randomized trials. JAMA 2014;311(4):355-356.
Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory review of novel therapeutics—comparison of three regulatory agencies. New England Journal of Medicine 2012;366(24):2284-2293.
Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012. JAMA 2014;311(4):368-377.
Fain K, Daubresse M, Alexander GC. The Food and Drug Administration Amendments Act and postmarketing commitments. JAMA 2013;310(2):202-204.
Kesselheim AS, Myers JA, Avorn J. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer. JAMA 2011;305:2320-2326
Ledford H. FDA under pressure to relax drug rules. Nature 2012;492:19.
Madigan D, Ryan P. What can we really learn from observational studies?: the need for empirical assessment of methodology for active drug safety surveillance and comparative effectiveness research. Epidemiology 2011;22(5):629-631.
Mayer M. Listen to all the voices: an advocate’s perspective on early access to investigational therapies. Clinical Trials 2006;3(2):149-153.
Moore TJ, Furberg CD. Development times, clinical testing, post-market follow-up, and safety risks for the new drugs approved by the US Food and Drug Administration: the class of 2008. JAMA Internal Medicine 2014;174:90-95.
Moore TJ, Furberg CD. The safety risks of innovation: the FDA’s expedited drug development pathway. JAMA 2012;308(9):869–870.
Prah Ruger J. Governing health. Harvard Law Review 2008;121:43-56.
Rome BN, Kramer DB, Kesselheim AS. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012. JAMA 2014;311(4):385-391.
Schneeweiss S, Gagne JJ, Glynn RJ, Ruhl M, Rassen JA. Assessing the comparative effectiveness of newly marketed medications: methodological challenges and implications for drug development. Clinical Pharmacology and Therapeutics 2011;90(6):777-790.
Schwartz LM, Woloshin S. Communicating uncertainties about prescription drugs to the public: a national randomized trial. Archives of Internal Medicine 2011;171(16):1463-1468.
Svensson S, Menkes DB, Lexchin J. Surrogate outcomes in clinical trials: a cautionary tale. JAMA Internal Medicine 2013;173(8):611-612.
SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. New England Journal of Medicine 2014;370(15):1393-1401.
Temple RJ. A regulatory authority’s opinion about surrogate endpoints. In <i>Clinical Measurement in Drug Evaluation</i> (WS Nimmo and GT Tucker, eds.). John Wiley & Sons, Ltd: 1995. Pg. 3-22.
Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Archives of Internal Medicine 2011;171(11):1006-1011. <i>Author Reply</i>. Archives of Internal Medicine 2011;171(21):1959-1964.