ACCESS TO INFORMATION;
CHRONIC PAIN;
CLINICAL RESEARCH;
CLINICAL STUDY;
CLINICAL STUDY REPORT;
DRUG APPROVAL;
DRUG EFFICACY;
DRUG INFORMATION;
DRUG MANUFACTURE;
DRUG PROGRAM;
DRUG RESEARCH;
DRUG SAFETY;
FOOD AND DRUG ADMINISTRATION;
FUNDING;
GASTROINTESTINAL DISEASE;
HEALTH PROGRAM;
HUMAN;
MEDICAID;
MEDICARE;
OFF LABEL DRUG USE;
PAIN;
PATENT;
PRACTICE GUIDELINE;
PRESCRIPTION;
PRIORITY JOURNAL;
PUBLIC HEALTH;
RISK BENEFIT ANALYSIS;
RISK FACTOR;
SHORT SURVEY;
TREATMENT INDICATION;
ARTICLE;
CLINICAL TRIAL (TOPIC);
DRUG INDUSTRY;
ECONOMICS;
INTERPERSONAL COMMUNICATION;
MANDATORY PROGRAM;
ORGANIZATION AND MANAGEMENT;
PUBLISHING;
REGISTER;
REPRODUCIBILITY;
STANDARD;
STATISTICAL ANALYSIS;
STATISTICS;
TREATMENT OUTCOME;
UNITED STATES;
ACCESS TO INFORMATION;
CLINICAL TRIALS AS TOPIC;
DATA INTERPRETATION, STATISTICAL;
DISCLOSURE;
DRUG INDUSTRY;
HUMANS;
MANDATORY PROGRAMS;
OFF-LABEL USE;
OWNERSHIP;
PRESCRIPTION DRUGS;
PUBLICATION BIAS;
REGISTRIES;
REPRODUCIBILITY OF RESULTS;
TREATMENT OUTCOME;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
Systematic review of the empirical evidence of study publication bias and outcome reporting bias
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.
Comparison of registered and published primary outcomes in randomized controlled trials
Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA. 2009;302(9):977-984.
International Conference on Harmonization: Guideline on Structure and Content of Clinical Study Reports
International Conference on Harmonization: Guideline on Structure and Content of Clinical Study Reports. Fed Regist. 1996;61(138):37320-37343.
(1996)Fed Regist, vol.61, Issue.138, pp. 37320-37343
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Outcome reporting in industry-sponsored trials of gabapentin for off-label use
Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med. 2009;361(20):1963-1971.
(2009)N Engl J Med, vol.361, Issue.20, pp. 1963-1971
Confidentiality laws and secrecy in medical research: Improving public access to data on drug safety
Kesselheim AS, Mello MM. Confidentiality laws and secrecy in medical research: improving public access to data on drug safety. Health Aff (Millwood). 2007;26(2):483-491.
The imperative to share clinical study reports: Recommendations from the Tamiflu experience
Doshi P, Jefferson T, Del Mar C. The imperative to share clinical study reports: recommendations from the Tamiflu experience. Plos Med. 2012;9(4):e1001201.
[press release]. European Medicines Agency website. November 30, Accessed June 28, 2012
European Medicines Agency widens public access to documents [press release]. European Medicines Agency website. http://www.ema.europa.eu/docs/en- GB/document-library/Press-release/2010/11/WC500099468.pdf. November 30, 2010. Accessed June 28, 2012.
Rofecoxib and clinically significant upper and lower gastrointestinal events revisited based on documents from recent litigation
Graham DY, Jewell NP, Chan FK. Rofecoxib and clinically significant upper and lower gastrointestinal events revisited based on documents from recent litigation. Am J Med Sci. 2011;342(5):356-364.
