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Clinical Trials eJournal

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Viewing: 1 - 50 of 215 papers

1.

Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs

Journal of Law, Medicine and Ethics, 2013, Vol. 14, No. 3: 590-610
Number of pages: 11 Posted: 20 Jun 2013 Last Revised: 12 Sep 2014
Accepted Paper Series
Rowan University School of Osteopathic Medicine, York University and Harvard Medical School
Downloads 5,857
2.

Spending on New Drug Development

Number of pages: 19 Posted: 15 Dec 2005 Last Revised: 08 Feb 2014
Working Paper Series
Federal Trade Commission - Bureau of Economics and Federal Trade Commission - Bureau of Economics
Downloads 1,019
3.

Pharmaceutical Development Phases: A Duration Analysis

FTC, Bureau of Economics Working Paper No. 274
Number of pages: 30 Posted: 25 Oct 2004
Working Paper Series
Global Economics Group, LLC, Federal Trade Commission - Bureau of Economics and Moody's Investors Service
Downloads 947
4.

Access to Information and the Right to Health: The Human Rights Case for Clinical Trials Transparency

American Journal of Law and Medicine, Vol. 38, pp. 63-112, 2012
Number of pages: 50 Posted: 27 Sep 2011 Last Revised: 06 Mar 2015
Accepted Paper Series
University of Toronto - Faculty of Law and Independent
Downloads 730
5.

Estate of Gelsinger v. Trustees of University of Pennsylvania: Money, Prestige, and Conflicts of Interest In Human Subjects Research

HEALTH LAW AND BIOETHICS: CASES IN CONTEXT, p. 229, Sandra H. Johnson, Joan H. Krause, Richard S. Saver, & Robin Fretwell Wilson, eds., Aspen Publishers, 2009, Washington & Lee Legal Studies Paper No. 2012-8
Number of pages: 37 Posted: 03 Mar 2012
Accepted Paper Series
University of Illinois College of Law
Downloads 715
6.

Machine-Learning Models for Predicting Drug Approvals

Number of pages: 42 Posted: 25 May 2017 Last Revised: 13 Oct 2018
Working Paper Series
Massachusetts Institute of Technology (MIT) - Sloan School of Management, Massachusetts Institute of Technology (MIT) and Massachusetts Institute of Technology (MIT)
Downloads 694
7.

The Human Factor: Globalizing Ethical Standards in Drug Trials through Market Exclusion

UGA Legal Studies Research Paper No. 08-007
Number of pages: 67 Posted: 22 Apr 2008
Working Paper Series
University of Georgia School of Law
Downloads 469
8.

The Death of Jesse Gelsinger: New Evidence of the Influence of Money and Prestige in Human Research

36 American Journal of Law & Medicine 295 (2010), Washington & Lee Legal Studies Paper No. 2012-19
Number of pages: 3 Posted: 10 Apr 2012
Accepted Paper Series
University of Illinois College of Law
Downloads 432
9.

The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives

Journal of Law, Medicine & Ethics, Vol. 31, No. 3, pp. 398-418, Fall 2003
Number of pages: 21 Posted: 09 Feb 2004 Last Revised: 06 Feb 2014
Accepted Paper Series
University of Toronto - Faculty of Law and Notre Dame Law School
Downloads 423
10.

The Use of Placebos in Clinical Trials: Responsible Research or Unethical Practice?

Connecticut Law Review, Forthcoming
Number of pages: 78 Posted: 18 Oct 2000
Accepted Paper Series
Case Western Reserve University School of Law
Downloads 406
11.

Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene

Journal of Law, Medicine & Ethics, Vol. 32, No. 4, pp. 641-657, 2004
Number of pages: 17 Posted: 04 Apr 2005 Last Revised: 06 Apr 2014
Accepted Paper Series
University of Toronto - Faculty of Law
Downloads 374
12.

Pharmaceutical Knowledge Governance: A Human Rights Perspective

Journal of Law, Medicine and Ethics, Vol. 41(1), pp. 163-184, 2013
Number of pages: 22 Posted: 05 Mar 2013 Last Revised: 16 Feb 2015
Accepted Paper Series
University of Toronto - Faculty of Law
Downloads 334
13.

Redefining Health Economics: How it Can Contribute to Better Healthcare Systems?

Researchjournali’s Journal of Economics Vol. 4 | No. 1 January | 2016 ISSN 2347-8233 ,
Number of pages: 12 Posted: 08 Feb 2016
Accepted Paper Series
Universidad Isalud
Downloads 286
14.

Duties to Subjects in Clinical Research

Vanderbilt Law Review, 2005
Number of pages: 59 Posted: 28 Jul 2004
Accepted Paper Series
Seton Hall University School of Law
Downloads 263
15.

Regulating Clinical Research: Informed Consent, Privacy, and Irbs

Capital University Law Review, Vol. 31, 2003
Number of pages: 25 Posted: 21 Apr 2003
Accepted Paper Series
Case Western Reserve University School of Law
Downloads 255
16.

Mandatory Clinical Trial Registration: Rebuilding Public Trust in Medical Research

GLOBAL FORUM UPDATE ON RESEARCH FOR HEALTH, Vol. 4: Equitable Access: Research Challenges for Health in Developing Countries, pp. 40-46, London: Pro-Book Publishing, 2007
Number of pages: 7 Posted: 14 Jan 2008 Last Revised: 17 Feb 2014
Accepted Paper Series
University of Toronto - Faculty of Law and University of Manitoba - Faculty of Law (deceased)
Downloads 232
17.

Independent Clinical Trials to Test Drugs: The Neglected Reform

Saint Louis University Journal of Health Law & Policy, Vol. 6, p. 113, 2012, Suffolk University Law School Research Paper No. 12-58
Number of pages: 55 Posted: 30 Dec 2012 Last Revised: 19 Aug 2013
Accepted Paper Series
Suffolk University Law School
Downloads 229
18.

Commercialized Medical Research and the Need for Regulatory Reform

U Toronto, Legal Studies Research Paper No. 967393, JUST MEDICARE: WHAT'S IN, WHAT'S OUT, HOW WE DECIDE, C. Flood, ed., University of Toronto Press, 2006
Number of pages: 17 Posted: 07 Mar 2007
Accepted Paper Series
University of Toronto - Faculty of Law
Downloads 219
19.

Does Focus Improve Operational Performance? Lessons from the Management of Clinical Trials

Number of pages: 37 Posted: 07 May 2005
Working Paper Series
Harvard Business School and Harvard Business School
Downloads 202
20.

Putting Contract Research Organisations on the Radar: An Exploratory Study on Outsourcing of Clinical Trials by Pharmaceutical Companies To Contract Research Organisations in Non-Traditional Trial Regions

Number of pages: 103 Posted: 13 Feb 2011
Working Paper Series
Stichting Onderzoek Multinationale Ondernemingen (SOMO), affiliation not provided to SSRN and affiliation not provided to SSRN
Downloads 197
21.

The Ethics of Postmarketing Observational Studies of Drug Safety Under Section 505(o)(3) of the Food, Drug, and Cosmetic Act

38 American Journal of Law and Medicine 577-606 (2012), U of Houston Law Center No. 2012-A-19
Number of pages: 30 Posted: 15 Mar 2012 Last Revised: 02 Jul 2014
Accepted Paper Series
University of Houston Law Center
Downloads 195
22.

FDA Regulation of Off-Label Promotion: An Answer

Number of pages: 21 Posted: 09 Feb 2012
Working Paper Series
Sidley Austin LLP
Downloads 184
23.

U.S. Regulatory Challenges for Gene Editing

Number of pages: 8 Posted: 29 Jul 2016
Working Paper Series
Loyola University Chicago School of Law
Downloads 181
24.

Conflicts of Interest in Clinical Research: Advocating for Patient-Subjects

Widener Law Symposium Journal, Vol. 8, No. 1, 2001
Number of pages: 10 Posted: 01 Apr 2002
Accepted Paper Series
Drexel University - Department of Family, Community & Preventive Medicine
Downloads 179
25.

Independent Drug Testing to Ensure Drug Safety and Efficacy

Journal of Health Care Law & Policy, Vol. 18, p. 43, 2015, Edmond J. Safra Working Papers, No. 23, Suffolk University Law School Research Paper No. 14-44
Number of pages: 40 Posted: 19 Sep 2013 Last Revised: 10 Jan 2015
Accepted Paper Series
Suffolk University Law School
Downloads 171
26.

The Limits of FDA's Authority to Regulate Clinical Research Involving High-Throughput DNA Sequencing

Symposium: Emerging Issues and New Frontiers for FDA Regulation, 70 Food and Drug Law Journal 259-287 (2015), U of Houston Law Center No. 2014-A74
Number of pages: 30 Posted: 22 Aug 2014 Last Revised: 26 Aug 2015
Accepted Paper Series
University of Houston Law Center
Downloads 171
27.

Cioms' Placebo Rule and the Promotion of Negligent Medical Practice

European Journal of Health Law, Vol. 11, pp. 153-174, 2004
Number of pages: 22 Posted: 02 Nov 2004
Accepted Paper Series
University of Toronto - Faculty of Law, University of Neuchatel, KU Leuven, University of KwaZulu-Natal and McGill University
Downloads 170
28.

Medical Research and Intangible Harm

University of Cincinnati Law Review, Vol. 74, p. 941, 2006, U of Houston Law Center No. 2006-A-23
Number of pages: 72 Posted: 03 Jul 2006
Accepted Paper Series
University of North Carolina School of Law
Downloads 169
29.

Why Is Research in Early-Stage Cancer Research so Low? A Re-Assessment of Budish, Roin and Williams (2015)

Number of pages: 26 Posted: 16 Jun 2017
Working Paper Series
Oregon Health and Science University and Oregon Health and Science University
Downloads 155
30.

Trusting Doctors: Tricky Business When it Comes to Clinical Trials

Boston University Law Review, Vol. 81, Pp. 423, 2001
Number of pages: 31 Posted: 31 Jul 2001
Accepted Paper Series
Boston University - School of Law
Downloads 154
31.

What to Do When You Can't Hear the Whistleblowing: A Proposal to Protect the Public's Health by Providing Whistleblower Protection for Medical Researchers

Indiana Health Law Review, Vol. 9
Number of pages: 96 Posted: 19 Apr 2011 Last Revised: 28 Jul 2013
Accepted Paper Series
Texas Tech University School of Law
Downloads 152
32.

Coerced Participation in Clinical Trials: Conscripting Human Research Subjects

Administrative Law Review, Vol. 62, No. 2, 2010
Number of pages: 38 Posted: 28 Apr 2010
Accepted Paper Series
University of Florida - Levin College of Law
Downloads 151
33.

Clinical Trials in Economics

American Economic Association, Ten Years and Beyond: Economists Answer NSF's Call for Long-Term Research Agendas
Number of pages: 2 Posted: 09 Aug 2011
Working Paper Series
University of California, Berkeley - School of Information
Downloads 149
34.

Welfare Versus Autonomy in Human Subjects Research

Florida State University Law Review, Forthcoming
Number of pages: 46 Posted: 09 Jul 2009 Last Revised: 09 Feb 2014
Accepted Paper Series
affiliation not provided to SSRN and University of Oxford - Uehiro Centre for Practical Ethics
Downloads 149
35.

Unbefriended and Unrepresented: Better Medical Decision Making for Incapacitated Patients Without Healthcare Surrogates

33(4) Georgia State University Law Review 923-1019 (2017)
Number of pages: 98 Posted: 09 May 2017 Last Revised: 16 Aug 2017
Accepted Paper Series
Mitchell Hamline School of Law
Downloads 136
36.

Beneficial and Unusual Punishment: An Argument in Support of Prisoner Participation in Clinical Trials

Indiana Law Review, Vol. 33, 1999
Number of pages: 44 Posted: 30 Mar 2000 Last Revised: 24 May 2014
Accepted Paper Series
Case Western Reserve University School of Law
Downloads 134
37.

What is Fair Participant Selection?

OXFORD TEXTBOOK OF CLINICAL RESEARCH ETHICS, Ezekiel J. Emanuel, et al eds., p. 377, 2008
Number of pages: 11 Posted: 01 Jul 2009
Accepted Paper Series
University of Maryland Francis King Carey School of Law and affiliation not provided to SSRN
Downloads 133
38.

Can Research Subjects of Clinical Trials in Developing Countries Sue Physician-Investigators for Human Rights Violations?

New York Law School Journal of Human Rights, Vol. 16, pp. 737-768, 2000
Number of pages: 32 Posted: 08 Dec 2000 Last Revised: 24 Feb 2015
Accepted Paper Series
Georgia State University College of Law
Downloads 130
39.

Medical Research Oversight from the Corporate Governance Perspective: Comparing Institutional Review Boards and Corporate Boards

William and Mary Law Review, Vol. 46, November 2004
Number of pages: 112 Posted: 27 Jul 2004
Accepted Paper Series
University of North Carolina School of Law
Downloads 128
40.

Shared Value for Patients and Pharmaceutical Companies

Number of pages: 14 Posted: 22 Jun 2011 Last Revised: 28 Jul 2013
Working Paper Series
DePaul University - Center for Strategy, Execution and Valuation
Downloads 124
41.

Introduction to: 'Human Subjects Research Regulation: Perspectives on the Future'

Human Subjects Research Regulation: Perspectives on the Future (I. Glenn Cohen & Holly Fernandez Lynch eds., MIT Press 2014)
Number of pages: 9 Posted: 04 Aug 2014
Accepted Paper Series
Harvard Law School and Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania
Downloads 123
42.

Protecting Trade Secrets Under International Investment Law: What Secrets Investors Should Not Tell States

John Marshall Review of Intellectual Property Law, Vol. 15 (2), 2016
Number of pages: 31 Posted: 28 Mar 2016
Working Paper Series
Max Planck Institute for Innovation and Competition
Downloads 117
43.

7th Revision of the Declaration of Helsinki: Good News for the Transparency of Clinical Trials

Croatian Medical Journal, Vol. 50, pp. 105-110, 2009
Number of pages: 6 Posted: 19 Aug 2011 Last Revised: 24 May 2014
Accepted Paper Series
Canadian Institute for Health Information and University of Toronto - Faculty of Law
Downloads 109
44.

Analytical Framework for Examining the Value of Antibacterial Products

Submitted to the U.S. Department of Health and Human Services, April 2014, Boston Univ. School of Law, Public Law Research Paper No. 14-25
Number of pages: 107 Posted: 22 Sep 2015 Last Revised: 22 Oct 2015
Accepted Paper Series
Eastern Research Group, Inc., Eastern Research Group, Inc., Eastern Research Group, Inc., Eastern Research Group, Inc., Eastern Research Group, Inc., Eastern Research Group, Inc. and Boston University School of Law
Downloads 105
45.

Human Rights and the Regulation of Transnational Clinical Trials

Political Studies, Forthcoming, Amsterdam Law School Research Paper No. 2012-23, General Subserie Research Paper No. 2012-01
Number of pages: 18 Posted: 16 Feb 2012 Last Revised: 21 Jun 2014
Accepted Paper Series
University of Amsterdam
Downloads 105
46.

Legal Regulation of the Use of Race in Medical Research

Journal of Law, Medicine & Ethics, Vol. 34, pp. 535-551, 2006, Seton Hall Public Law Research Paper No. 970683
Number of pages: 33 Posted: 16 Mar 2007
Accepted Paper Series
Seton Hall University - School of Law and Seton Hall University - School of Law
Downloads 104
47.

In Plain Sight: A Solution to a Fundamental Challenge in Human Research

Journal of Law, Medicine, and Ethics, Forthcoming, Virginia Public Law and Legal Theory Research Paper No. 2012-54
Number of pages: 24 Posted: 09 Sep 2012 Last Revised: 24 May 2014
Accepted Paper Series
University of Virginia Center for Biomedical Ethics and Humanities and University of Virginia School of Law
Downloads 101
48.

Crowdsourcing Clinical Trials

Minnesota Law Review, Vol. 98, 805, 2014
Number of pages: 63 Posted: 28 Jan 2014
Accepted Paper Series
Harvard Medical School
Downloads 100
49.

Continued Concern: Human Subject Protection, the Irb, and Continuing Review

Tennessee Law Review, Forthcoming
Number of pages: 59 Posted: 15 May 2001
Accepted Paper Series
Case Western Reserve University School of Law
Downloads 96
50.

The Markingson Case and the Ethics of Institutional Proceduralism

in Trudo Lemmens and Bernadette J. Richards, "Recent Developments: Investigating research and Accessing Reproductive Material" (2014) 11(1) Bioethical Inquiry 11-16 DOI 10.1007/s11673-013-9503-2
Number of pages: 9 Posted: 31 Mar 2014 Last Revised: 07 Apr 2014
Accepted Paper Series
University of Toronto - Faculty of Law
Downloads 94