The need for improved access to FDA reviews

JAMA

Volumn 302, Issue 2, 2009, Pages 191-193

  O'Connor, Alec B ^a,b  

^a UNIVERSITY OF ROCHESTER SCHOOL OF MEDICINE AND DENTISTRY   (United States)

^b STRONG MEMORIAL HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDEPRESSANT AGENT; FENTANYL CITRATE; PREGABALIN;

ACCESS TO INFORMATION; CANCER PAIN; CENTRAL NERVOUS SYSTEM DEPRESSION; CHRONIC PAIN; CLINICAL RESEARCH; DATA ANALYSIS; DIABETIC NEUROPATHY; DRUG DEPENDENCE; DRUG INDICATION; DRUG TOLERABILITY; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION PROCESSING; INTERNET; LAW; MEDICAL LITERATURE; MEDLINE; METHODOLOGY; NEUROPATHIC PAIN; NOTE; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PEER REVIEW; PRIORITY JOURNAL; PUBLICATION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STATISTICAL ANALYSIS; SYSTEMATIC ERROR; UNSPECIFIED SIDE EFFECT; ARTICLE; CLINICAL TRIAL; DRUG APPROVAL; INFORMATION DISSEMINATION; PUBLISHING; REGISTER; UNITED STATES;

CLINICAL TRIALS AS TOPIC; DATA INTERPRETATION, STATISTICAL; DRUG APPROVAL; INFORMATION DISSEMINATION; MEDLINE; PEER REVIEW, RESEARCH; PUBLICATION BIAS; REGISTRIES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 67650106430     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2009.973     Document Type: Note

References (15)

1. Oxford Centre for Evidence-Based Medicine - levels of evidence (March 2009). http://www.cebm.net/index.aspx?o=1025. Accessed June 12, 2009.
2. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252-260.
3. Dwan K, Altman DG, Arnaiz JA, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS ONE. 2008;3(8):e3081.
4. DeAngelis CD, Fontanarosa PB. Impugning the integrity of medical science: the adverse effects of industry influence. JAMA. 2008;299(15):1833-1835.
5. Zarin DA, Tse T. Moving toward transparency of clinical trials. Science. 2008;319(5868):1340-1342.
6. Wood AJ. Progress and deficiencies in the registration of clinical trials. N Engl J Med. 2009;360(8):824-830.
7. Center for Drug Evaluation and Research. Approval Package for Application Number 21-446: Medical Review(s). http://www.accessdata.fda.gov/ drugsatfda-docs/nda/2004/021446-Lyrica%20Capsules-medr.pdf. Accessed June 12, 2009.
8. Lesser H, Sharma U, LaMoreaux L, Poole RM. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology. 2004;63(11):2104-2110.
9. Rosenstock J, Tuchman M, LaMoreaux L, Sharma U. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain. 2004;110(3):628-638.
10. Richter RW, Portenoy R, Sharma U, Lamoreaux L, Bockbrader H, Knapp LE. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain. 2005;6(4):253-260.
11. Tölle T, Freynhagen R, Versavel M, Trostmann U, Young JP Jr. Pregabalin for relief of neuropathic pain associated with diabetic neuropathy: a randomized, double-blind study. Eur J Pain. 2008;12(2):203-213.
12. O'Connor AB, Noyes K, Holloway RG. A cost-utility comparison of four first-line medications in painful diabetic neuropathy. Pharmacoeconomics. 2008;26(12):1045-1064.
13. Center for Drug Evaluation and Research. Memorandum [summary of the medical review for Supplemental NDA 21-947/S005]. April 26, 2008. http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4356b2-01-FDA.pdf. Accessed June 12, 2009.
14. Drugs@FDA. http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/. Accessed June 12, 2009.
15. Lyrica [product label]. http://www.accessdata.fda.gov/drugsatfda-docs/ label/2007/021446s010lbl.pdf. Accessed June 12, 2009.