In the past, postmarketing research, postmarketing surveillance and pharmacovigilance were synonymous with phase IV studies because the main activities of the regulatory agency (e.g. FDA) were focused on the monitoring of adverse drug events and inspections of drug manufacturing facilities and products. (1) However, the fact that not all FDA mandated (classical phase IV trials) research consists of randomized controlled trials (RCTs), and not all postmarketing activities are limited to safety issues (pharmacovigilance), these terms require clarification. This chapter attempts to clarify the confusing terminology; and, to discuss many of the postmarketing research designs-both their place in clinical research as well as their limitations.
KeywordsCardiac Rehabilitation Adverse Drug Event Health Outcome Research Conditional Approval Neonatal Abstinence Syndrome
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- 1.Hartzema A. Pharmacoepidemiology. Vol 41. 3rd ed. Cincinnati, OH: Harvey Whitney Books Company; 1998.Google Scholar
- 9.Farahani P, Levine M, Gaebel K, Thabane L. Clinical data gap between phase III clinical trials (pre-marketing) and phase IV (post-marketing) studies: evaluation of etanercept in rheumatoid arthritis. Can J Clin Pharmacol. Fall 2005; 12(3):e254–263.Google Scholar
- 20.Ueng KC, Chen ZC, Yeh PS, et al. Nifedipine OROS in Chinese patients with hypertension–results of a post-marketing surveillance study in Taiwan. Blood Press Suppl. July 2005; 1:32–38.Google Scholar
- 28.Lurie P. FDA Report Highlights Poor Enforcement of Post-Marketing Follow-up. http://www.citizen.org/pressroom/release.cfm?ID=2147. Accessed October 12, 2006.
- 30.Smith DH, Neutel JM, Lacourciere Y, Kempthorne-Rawson J. Prospective, randomized, open-label, blinded-endpoint (PROBE) designed trials yield the same results as double-blind, placebo-controlled trials with respect to ABPM measurements. J Hypertens. July 2003; 21(7):1291–1298.PubMedCrossRefGoogle Scholar
- 32.FDA news Drug Daily Bulletin. Oct 2006; 3(207).Google Scholar
- 37.Merck & Co I. http://www.vioxx.com/vioxx/documents/english/vioxx_press_release.pdf. Accessed October 4.
- 39.FDA. MedWatch: Voluntary Reporting by Health Professionals. http://www.fda.gov/medwatch/report/hcp.htm. Accessed October 12, 2006.
- 43.Taylor R, Bethell H, Brodie D. Clinical trial versus the real world: the example of cardiac rehabilitation. Br J Cardiol. 2007; 14:175–178.Google Scholar
- 45.Chilcott J, Brennan A, Booth A, Karnon J, Tappenden P. The role of modelling in prioritising and planning clinical trials. Health Technol Assess. 2003; 7(23):iii, 1–125.Google Scholar
- 52.Institute of Medicine of the National Academies. The Future of Drug Safety. http://www.nap.edu/books/0303103045/html/1.html. Accessed April 3, 2007.
- 53.Public Health Newswire. Drug’s Black Box Warning Violations in Outpatient Settings Putting Patients at Risk. http://www.medicalnewstoday.com/medicalnews.php?newsid=37735. Accessed April 3, 2007.