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Are these data real? Statistical methods for the detection of data fabrication in clinical trials, Al-Marzouki, Sanaa, Evans Stephen, Marshall Tom, and Roberts Ian , BMJ: British Medical Journal, Volume 331, Issue 7511, p.267-270, (2005) Abstract

Al-Marzouki, Sanaa 1 Evans, Stephen 2; Email Address: stephen.evans@Lshtm.ac.uk Marshall, Tom 3 Roberts, Ian 4; Affiliation: 1: Research student, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT 2: Professor of pharmacoepidemiology, Medical Statistics Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT 3: Senior lecturer in medical statistics, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT 4: Professor of epidemiology and public health, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT; Source Info: 7/30/2005, Vol. 331 Issue 7511, p267; Subject Term: CLINICAL trials; Subject Term: MEDICINE -- Research; Subject Term: RESEARCH -- Moral & ethical aspects; Subject Term: DATA analysis; Subject Term: STATISTICS; Subject Term: METHODOLOGY; Subject Term: CARDIOVASCULAR system -- Diseases; Subject Term: DRUGS -- Testing; NAICS/Industry Codes: 541712 Reseach and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); Number of Pages: 4p; Illustrations: 4 Charts; Document Type: Article

Clinical Trials of Drugs Used Off-Label in Neonates: Ethical Issues and Alternative Study Designs, Amin, Sanjiv B., McDermott Michael P., and Shamoo Adil E. , Accountability in Research: Policies & Quality Assurance, Volume 15, Issue 3, p.168-187, (2008) Abstract

Amin, Sanjiv B. 1; Email Address: sanjiv_amin@urmc.rochester.edu; McDermott, Michael P. 2; Shamoo, Adil E. 3; Affiliations: 1: Department of Pediatrics, University of Rochester School of Medicine, Rochester, New York, USA; 2: Departments of Biostatistics and Computational Biology and Neurology, University of Rochester School of Medicine, Rochester, New York, USA; 3: Departments of Biochemistry and Molecular Biology and Epidemiology and Preventive Medicine, University of Maryland, School of Medicine, Baltimore, Maryland, USA; Issue Info: Jul-Sep2008, Vol. 15 Issue 3, p168; Thesaurus Term: TESTING; Subject Term: CLINICAL trials; Subject Term: DRUGS; Subject Term: NEWBORN infants; Subject Term: OFF-label use (Drugs); Subject: UNITED States; Author-Supplied Keyword: active control; Author-Supplied Keyword: alternative study designs; Author-Supplied Keyword: clinical trials; Author-Supplied Keyword: ethics; Author-Supplied Keyword: neonatal emergency research; Author-Supplied Keyword: neonates; Author-Supplied Keyword: off-label; Author-Supplied Keyword: placebo; Author-Supplied Keyword: unlicensed ; Company/Entity: UNITED States. Food & Drug Administration ; Company/Entity: NATIONAL Institutes of Health (U.S.); Number of Pages: 20p; Illustrations: 2 Charts; Document Type: Article

How Much Is More Life Worth?, Brock, Dan W. , Hastings Center Report, Volume 36, Issue 3, p.17-19, (2006) Abstract

3Accession Number: 20826341; Brock, Dan W.; Source Info: May/Jun2006, Vol. 36 Issue 3, p17; Subject Term: ETHICS; Subject Term: DRUGS -- Prices; Subject Term: PRICE increases; Subject Term: ANTINEOPLASTIC agents; Subject Term: PHARMACEUTICAL industry; Company/Entity: GENENTECH Inc. Ticker: DNA; NAICS/Industry Codes: 325412 Pharmaceutical Preparation Manufacturing; Number of Pages: 3p; Document Type: Editorial

Balancing Privacy Protections with Efficient Research: Institutional Review Boards and the Use of Certificates of Confidentiality, Currie, Peter M. , IRB: Ethics & Human Research, Volume 27, Issue 5, p.7-12, (2005) Abstract

Currie, Peter M. 1; Affiliation: 1: Georgetown University Law Center, Washington, DC.; Source Info: Sep/Oct2005, Vol. 27 Issue 5, p7; Subject Term: INSTITUTIONAL review boards (Medicine); Subject Term: RESEARCH; Subject Term: DISCLOSURE of information; Subject Term: DRUGS -- Law & legislation; Subject Term: DRUG abuse -- Prevention; Subject Term: MEDICAL ethics committees; Number of Pages: 6p; Document Type: Article

Sex, Politics, and Morality at the FDA: Reflections on the Plan B Decision, Davidoff, Frank , Hastings Center Report, Volume 36, Issue 4, p.20-25, (2006) Abstract

2Accession Number: 20320610; Davidoff, Frank; Source Info: Mar/Apr2006, Vol. 36 Issue 2, p20; Subject Term: CONTRACEPTIVES; Subject Term: GOVERNMENT policy; Subject Term: DRUGS, Nonprescription; Subject Term: MEETINGS; Subject Term: ABORTION; Subject Term: UNITED States; Company/Entity: UNITED States. Food & Drug Administration; Number of Pages: 6p; Document Type: Editorial

Plan B: Politics and Values at the FDA, Again, Dresser, Rebecca , Hastings Center Report, Volume 34, Issue 6, p.9-10, (2004) Abstract

Dresser, Rebecca; Source Info: Nov/Dec2004, Vol. 34 Issue 6, p9; Subject Term: DRUGS, Nonprescription; Subject Term: CONTRACEPTIVE drugs; Subject Term: UNITED States; Company/Entity: BARR Pharmaceuticals Inc. Company/Entity: UNITED States. Food & Drug Administration; Number of Pages: 2p; Document Type: Article

A New Era in Drug Regulation?, Dresser, Rebecca , Hastings Center Report, Volume 35, Issue 3, p.10-11, (2005) Abstract

Dresser, Rebecca; Source Info: May/Jun2005, Vol. 35 Issue 3, p10; Subject Term: DRUGS -- Law & legislation; Subject Term: LAW reform; Subject Term: DRUGS -- Standards; Subject Term: MEDICINE -- Research; Subject Term: UNITED States; Company/Entity: UNITED States. Food & Drug Administration; NAICS/Industry Codes: 541712 Reseach and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); Number of Pages: 2p; Document Type: Article

The Curious Case of Off-Label Use, Dresser, Rebecca , Hastings Center Report, Volume 37, Issue 3, p.9-11, (2007) Abstract

Dresser, Rebecca; Source Info: May/Jun2007, Vol. 37 Issue 3, p9; Subject Term: DRUGS; Subject Term: DRUGS -- Administration; Subject Term: MEDICINE -- Formulae, receipts, prescriptions; Subject Term: LABELING; Subject Term: UNITED States; Company/Entity: UNITED States. Food & Drug Administration; Number of Pages: 3p; Document Type: Article

Pharma Goes to the Laundry: Public Relations and the Business of Medical Education, Elliott, Carl , Hastings Center Report, Volume 34, Issue 2, p.18-23, (2004) Abstract

Hastings Center ReportAccession Number: 14774056; Elliott, Carl; Source Info: Sep/Oct2004, Vol. 34 Issue 5, p18; Subject Term: MEDICAL education; Subject Term: PHARMACEUTICAL industry; Subject Term: PUBLIC relations; Subject Term: MEDICAL literature; Subject Term: DRUGS; Subject Term: FINANCE; Company/Entity: WYETH (Company) (1860-2009); NAICS/Industry Codes: 424210 Drugs and Druggists' Sundries Merchant Wholesalers; NAICS/Industry Codes: 611310 Colleges, Universities, and Professional Schools; NAICS/Industry Codes: 325412 Pharmaceutical Preparation Manufacturing; NAICS/Industry Codes: 541820 Public Relations Agencies; Number of Pages: 6p; Document Type: Essay

Protecting the Nation's Military May Include the Use of Investigational New Drugs, Embrey, Ellen , Accountability in Research: Policies & Quality Assurance, Volume 10, Issue 2, p.85, (2003) Abstract

Embrey, Ellen; Issue Info: Apr2003, Vol. 10 Issue 2, p85; Subject Term: ARMED Forces; Subject Term: DRUGS; NAICS/Industry Codes: 424210 Drugs and Druggists' Sundries Merchant Wholesalers; Number of Pages: 6p; Document Type: Article

Praxis makes perfect?, Fins, Joseph J. , Hastings Center Report, Volume 23, Issue 5, p.16-19, (1993) Abstract

Fins, Joseph J.; Source Info: Sep/Oct93, Vol. 23 Issue 5, p16; Subject Term: DRUGS; Subject Term: HOSPITALS -- Administration; Subject Term: PURCHASING; NAICS/Industry Codes: 424210 Drugs and Druggists' Sundries Merchant Wholesalers; Number of Pages: 4p; Document Type: Article; Full Text Word Count: 2795

Ethical, Evidence-Based Guidelines for Contraceptive Use in Research, Kaposy, Chris, and Baylis Françoise , IRB: Ethics & Human Research, Volume 32, Issue 5, p.1-9, (2010) Abstract

Kaposy, Chris 1 Baylis, Françoise 2; Affiliation: 1: Assistant Professor of Health Care Ethics, Memorial University of Newfoundland, St. John¿s, NL, Canada 2: Professor and Canada Research Chair in Bioethics and Philosophy, Dalhousie University, Halifax, NS, Canada; Source Info: Sep/Oct2010, Vol. 32 Issue 5, p1; Subject Term: CLINICAL trials; Subject Term: CONTRACEPTION; Subject Term: DRUGS; Subject Term: FETUS; Subject Term: MEDICAL policy; Subject Term: MEDICAL protocols; Subject Term: MEDICINE -- Research; Subject Term: RESEARCH -- Moral & ethical aspects; Subject Term: EVIDENCE-based medicine; Subject Term: INSTITUTIONAL review boards (Medicine); Subject Term: RESEARCH subjects (Persons); Subject Term: DRUGS -- Physiological effect; Subject Term: ETHICS; Subject Term: LABELING; Subject Term: UNITED States; Company/Entity: UNITED States. Food & Drug Administration; NAICS/Industry Codes: 923120 Administration of Public Health Programs; NAICS/Industry Codes: 541712 Reseach and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); Number of Pages: 9p; Illustrations: 1 Chart; Document Type: Article

Parenting in an era of genetics, McGee, Glenn , Hastings Center Report, Volume 27, Issue 2, p.16-22, (1997) Abstract

McGee, Glenn; Source Info: Mar/Apr97, Vol. 27 Issue 2, p16; Subject Term: DRUGS; Subject Term: PARENTING; Subject Term: MORAL & ethical aspects; Number of Pages: 7p; Document Type: Article; Full Text Word Count: 5949

Experimentality: on the global mobility and regulation of human subjects research , Petryna, Adriana , Polar: political and legal anthropology review, Volume 30, Issue 2, p.288-304, (2007) Abstract

in thematic issue 'Papering ethics, documenting consent: the new bureaucracies of virtue'article

Comparing Drug Effectiveness at Health Plans: The Ethics of Cluster Randomized Trials, Sabin, James E., Mazor Kathleen, Meterko Vanessa, Goff Sarah L., and Platt Richard , Hastings Center Report, Volume 38, Issue 5, p.39-48, (2008) Abstract

SABIN, JAMES E. MAZOR, KATHLEEN METERKO, VANESSA GOFF, SARAH L. PLATT, RICHARD; Source Info: Sep/Oct2008, Vol. 38 Issue 5, p39; Subject Term: DRUGS -- Effectiveness; Subject Term: RESEARCH; Subject Term: CLINICAL trials; Subject Term: METHODOLOGY; Subject Term: MEDICINE -- Research; Subject Term: RANDOMIZED controlled trials; NAICS/Industry Codes: 541712 Reseach and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); Number of Pages: 10p; Document Type: Article

Contraception in Research:A Policy Suggestion, Schonfeld, Toby L., and Gordon Bruce G. , IRB: Ethics & Human Research, Volume 27, Issue 2, p.15-20, (2005) Abstract

Schonfeld, Toby L. Gordon, Bruce G.; Source Info: Mar/Apr2005, Vol. 27 Issue 2, p15; Subject Term: DRUGS -- Research; Subject Term: WOMEN -- Physiology; Subject Term: BIRTH control; Subject Term: CONTRACEPTION; Subject Term: FETUS; Subject Term: PREGNANT women; Subject Term: RESEARCH; NAICS/Industry Codes: 621410 Family Planning Centers; Number of Pages: 6p; Document Type: Article

Playing with propranolol, Slomka, Jacquelyn , Hastings Center Report, Volume 22, Issue 4, p.13-17, (1992) Abstract

Slomka, Jacquelyn; Source Info: Jul/Aug92, Vol. 22 Issue 4, p13; Subject Term: DRUGS; NAICS/Industry Codes: 424210 Drugs and Druggists' Sundries Merchant Wholesalers; Number of Pages: 5p; Document Type: Article; Full Text Word Count: 4183

Opinion: Gene patenting and medical research: a view from a pharmaceutical company, Stott, Mike, and Valentine Jill , Nature Reviews Drug Discovery, Volume 3, Issue 4, p.364-368, (2004) Abstract

Stott, Mike 1; Email Address: jill.b.valentine@gsk.com Valentine, Jill 1; Email Address: mike.j.stoll@gsk.com; Affiliation: 1: Corporate Intellectual Property, Glaxo Smith Khine plc, 980, Great West Road, Brentford, Middlesex, TW8 9GS, UK.; Source Info: Apr2004, Vol. 3 Issue 4, p364; Subject Term: PHARMACEUTICAL industry; Subject Term: PATENTS; Subject Term: MEDICINE -- Research; Subject Term: DRUGS -- Research; Subject Term: DRUGS -- Design; Subject Term: DRUG development; NAICS/Industry Codes: 541712 Reseach and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); NAICS/Industry Codes: 325412 Pharmaceutical Preparation Manufacturing; Number of Pages: 5p; Document Type: Article

Testing Drugs in Pediatric Populations: The FDA Mandate, Tauer, Carol A. , Accountability in Research: Policies & Quality Assurance, Volume 7, Issue 1, p.37, (1999) Abstract

Tauer, Carol A.; Issue Info: Oct99, Vol. 7 Issue 1, p37; Thesaurus Term: TESTING; Thesaurus Term: GOVERNMENT policy; Thesaurus Term: RESEARCH; Subject Term: DRUGS; Subject Term: CHILDREN; Subject Term: MORAL & ethical aspects; Subject: UNITED States ; Company/Entity: UNITED States. Food & Drug Administration; Number of Pages: 22p; Document Type: Article; Full Text Word Count: 8356

The Antidepressant Debate and Ethically Defensible Placebo-Controlled Trials, Waring, Duff R. , IRB: Ethics & Human Research, Volume 30, Issue 6, p.12-16, (2008) Abstract

Waring, Duff R.; Source Info: Nov/Dec2008, Vol. 30 Issue 6, p12; Subject Term: MEDICAL ethics; Subject Term: MEDICINE -- Research; Subject Term: PLACEBOS (Medicine); Subject Term: CLINICAL trials; Subject Term: ANTIDEPRESSANTS; Subject Term: PSYCHOTROPIC drugs; Subject Term: DRUGS -- Testing; Subject Term: MORAL & ethical aspects; Subject Term: RANDOMIZED controlled trials; Number of Pages: 5p; Document Type: Article

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis, Weihrauch, Thomas R. , Science & Engineering Ethics, Volume 10, Issue 1, p.151-155, (2004) Abstract

Weihrauch, Thomas R. 1; Email Address: thomas.weihrauch.tw@bayer-ag.de; Affiliation: 1: Pharmaceutical Research Center, Bayer AG, Germany; Source Info: Jan2004, Vol. 10 Issue 1, p151; Subject Term: PLACEBOS (Medicine); Subject Term: DRUGS -- Effectiveness; Subject Term: SAFETY; Subject Term: DRUGS -- Side effects; Subject Term: MEDICAL ethics; Author-Supplied Keyword: adverse drug reactions; Author-Supplied Keyword: clinical trials; Author-Supplied Keyword: Declaration of Helsinki; Author-Supplied Keyword: efficacy; Author-Supplied Keyword: ethics; Author-Supplied Keyword: placebo; Number of Pages: 5p; Illustrations: 1 Diagram; Document Type: Article

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