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Importance and challenges of studying marketed drugs: what is a phase IV study? Common clinical research designs, registries, and self-reporting systems.
J Clin Pharmacol. 2007 Sep; 47(9):1074-86.JC

Abstract

The new drug application database submitted to the US Food and Drug Administration for drug approval (phases I-III or phases 1-3) is limited both in scope and size. Although randomized controlled trials, the hallmark of phase III trials, are the gold standard for the drug-approval process, they invariably have a number of limitations, including relatively small sample sizes, selective populations, short follow-up, the use of intermediate (surrogate) endpoints (almost always), and limited generalizability. The challenges of monitoring drugs once approved are also numerous. After approval by the Food and Drug Administration, marketed drugs undergo continued scrutiny, and this scrutiny is increasing because of problems that have surfaced with some drugs after their approval. Postmarketing research includes a variety of study designs and the use of registries and self-reporting of drug side effects. Along with this has come great confusion about what postmarketing research is and what a phase IV study is. Among the important strengths of phase IV research are the exposure of a broader range of patients to the drug under study, resulting in more "real-world" information about the drug's safety and efficacy, and consideration of a broader range of clinical endpoints. As a result, phase IV, or postmarketing research, has become an integral part of the drug evaluation process for a wide range of agents. The authors discuss the different types of study designs that are common under the phase IV terminology and provide some examples. They also discuss the use of registries and self-reporting of adverse events using the MedWatch System.

Authors+Show Affiliations

University of Alabama at Birmingham, Division of Prev. Medicine, 1717 11th Ave S, MT638, Birmingham, AL 35205-4731, USA.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

17766697

Citation

Glasser, Stephen P., et al. "Importance and Challenges of Studying Marketed Drugs: what Is a Phase IV Study? Common Clinical Research Designs, Registries, and Self-reporting Systems." Journal of Clinical Pharmacology, vol. 47, no. 9, 2007, pp. 1074-86.
Glasser SP, Salas M, Delzell E. Importance and challenges of studying marketed drugs: what is a phase IV study? Common clinical research designs, registries, and self-reporting systems. J Clin Pharmacol. 2007;47(9):1074-86.
Glasser, S. P., Salas, M., & Delzell, E. (2007). Importance and challenges of studying marketed drugs: what is a phase IV study? Common clinical research designs, registries, and self-reporting systems. Journal of Clinical Pharmacology, 47(9), 1074-86.
Glasser SP, Salas M, Delzell E. Importance and Challenges of Studying Marketed Drugs: what Is a Phase IV Study? Common Clinical Research Designs, Registries, and Self-reporting Systems. J Clin Pharmacol. 2007;47(9):1074-86. PubMed PMID: 17766697.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Importance and challenges of studying marketed drugs: what is a phase IV study? Common clinical research designs, registries, and self-reporting systems. AU - Glasser,Stephen P, AU - Salas,Maribel, AU - Delzell,Elizabeth, PY - 2007/9/4/pubmed PY - 2007/11/7/medline PY - 2007/9/4/entrez SP - 1074 EP - 86 JF - Journal of clinical pharmacology JO - J Clin Pharmacol VL - 47 IS - 9 N2 - The new drug application database submitted to the US Food and Drug Administration for drug approval (phases I-III or phases 1-3) is limited both in scope and size. Although randomized controlled trials, the hallmark of phase III trials, are the gold standard for the drug-approval process, they invariably have a number of limitations, including relatively small sample sizes, selective populations, short follow-up, the use of intermediate (surrogate) endpoints (almost always), and limited generalizability. The challenges of monitoring drugs once approved are also numerous. After approval by the Food and Drug Administration, marketed drugs undergo continued scrutiny, and this scrutiny is increasing because of problems that have surfaced with some drugs after their approval. Postmarketing research includes a variety of study designs and the use of registries and self-reporting of drug side effects. Along with this has come great confusion about what postmarketing research is and what a phase IV study is. Among the important strengths of phase IV research are the exposure of a broader range of patients to the drug under study, resulting in more "real-world" information about the drug's safety and efficacy, and consideration of a broader range of clinical endpoints. As a result, phase IV, or postmarketing research, has become an integral part of the drug evaluation process for a wide range of agents. The authors discuss the different types of study designs that are common under the phase IV terminology and provide some examples. They also discuss the use of registries and self-reporting of adverse events using the MedWatch System. SN - 0091-2700 UR - https://www.unboundmedicine.com/medline/citation/17766697/Importance_and_challenges_of_studying_marketed_drugs:_what_is_a_phase_IV_study_Common_clinical_research_designs_registries_and_self_reporting_systems_ L2 - https://doi.org/10.1177/0091270007304776 DB - PRIME DP - Unbound Medicine ER -