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

Volumn 22, Issue 5, 2011, Pages 629-631

  Madigan, David ^a   Ryan, Patrick ^b  

^a Och Spine at New York Presbyterian Hospitals   (United States)

^b JOHNSON AND JOHNSON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COMPARATIVE EFFECTIVENESS; DISEASE SURVEILLANCE; DRUG SAFETY; HEALTH CARE; HEALTH SERVICE; HUMAN; MEDICAL INFORMATICS; MEDICAL RESEARCH; METHODOLOGY; NOTE; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PHARMACOEPIDEMIOLOGY; PRIORITY JOURNAL; RISK;

COMPARATIVE EFFECTIVENESS RESEARCH; DRUG EVALUATION; EMPIRICAL RESEARCH; EPIDEMIOLOGIC METHODS; OBSERVATION; PHARMACOEPIDEMIOLOGY; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 80051528475     PISSN: 10443983     EISSN: 15315487     Source Type: Journal    
DOI: 10.1097/EDE.0b013e318228ca1d     Document Type: Note

References (11)

1. Food and Drug Administration Amendments Act of 2007. Pub L No. 110-85.
2. Federal Coordinating Council for Comparative Effectiveness Research Report to the President and the Congress. US Department of Health and Human Services; 2009. Available at: http://www.hhs.gov/recovery/ programs/cer/ cerannualrpt.pdf. Accessed 27 June 2011.
3. Stang PE, Ryan PB, Racoosin JA, et al. Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Ann Intern Med. 2010;153:600-606.
4. IMI-PROTECT. 2011. Available at: http://www.imi-protect.eu/.
5. Coloma PM, et al. Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiol Drug Saf. 2011;20:1-11.
6. http://www.brookings.edu/-/media/Files/events/2010/0921-signal- refinement/08-Session%20II-Lieu.pdf.
7. Ioannidis JP. Why most published research findings are false. PLoS Med. 2005;2:e124.doi:10.1371/journal.pmed. 0020124.
8. Temple R. Meta-analysis and epidemiologic studies in drug development and postmarketing surveillance. JAMA. 1999;281:841-844. (Pubitemid 29113746)
9. Green J, et al. Oral bisphosphonates and risk of cancer of oesophagus, stomach, and colorectum: case-control analysis within a UK primary care cohort. BMJ. 2010;341:c4444.
10. Cardwell CR, et al. Exposure to oral bisphosphonates and risk of esophageal cancer. JAMA. 2010;304:657-663.
11. Dreyer NA, et al. Why observational studies should be among the tools used in comparative effectiveness research. Health Aff. 2010;29:1818-1825.