Ethical and scientific issues in studying the safety of approved drugs / Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies.

Format:

Book

Contributor:

Institute of Medicine (U.S.). Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs.

Institute of Medicine (U.S.). Board on Population Health and Public Health Practice.

National Academies Press (U.S.)

Language:

English

Subjects (All):

Drugs--Testing--Moral and ethical aspects--United States.

Drugs.

Clinical trials--Moral and ethical aspects--United States.

Clinical trials.

Drug approval--United States.

Drug approval.

Physical Description:

1 online resource (291 p.)

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academies Press, c2012.

Language Note:

English

Summary:

An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.

Contents:

""Front Matter""; ""Reviewers""; ""Preface""; ""In Memoriam

Dr. Thomas Ten Have""; ""Contents""; ""Abstract""; ""Summary""; ""1 Introduction""; ""2 Incorporating Benefit and Risk Assessment and Benefit-Risk Management into Food and Drug Administration Decision-Making""; ""3 Evidence and Decision-Making""; ""4 Selection and Oversight of Required Postmarketing Studies""; ""5 Synthesis""; ""Appendix A: Other Elements of the Food and Drug Administration Amendments Act""; ""Appendix B: Committee's Letter Report""; ""Appendix C: Open Session Agendas""

""Appendix D: Decision Conferencing and Multicriteria Decision Analysis""""Appendix E: Benefit and Risk Assessment and Management Plan Document Template""; ""Appendix F: Committee Biosketches""

Notes:

Description based upon print version of record.

Includes bibliographical references.

ISBN:

9780309218160

0309218160

9781283636445

1283636441

9780309218146

0309218144

OCLC:

811594850