Clinical Research Practice Guide, First Edition with CD-ROM (AHLA Members)
American Health Lawyers Association Mark G. Bloom, J.D., C.L.P., C.R.C.P.; Patricia Brent, J.D., M.P.H.; J. Andrew Lemons, Esquire; Melissa L. Markey, Esquire; R. Harold McCard, Esquire; Elizabeth J. McCubrey, Esquire, M.P.H.; Lena Robins, Esquire; Lawrence W. Vernaglia, J.D., M.P.H.
CHAPTER 1. Protection of Human Research Subjects Protection of Human Subjects
Background of Human Subject Protection
Research and Informed Consent
CHAPTER 2. Institutional Review Boards: Ensuring the Protection of Human Research Participants The Development of Human Subject Protection
Federal Regulation of Research
Applicability of Federal IRB Regulations
The IRB Review Process
CHAPTER 3. A Brief Overview of the Federal Regulatory Approval Process for Pharmaceuticals, Medical Devices, and Biologicals The Drug Research Process
Stages of a Clinical Trial
Investigational New Drug Application
New Drug Application
Abbreviated New Drug Application
Regulation of Medical Devices
Regulatory Process Relating to Biologicals
CHAPTER 4. Regulatory Oversight and Investigations FDA
Office for Human Research Protections
Office of Research Integrity
National Institutes of Health
Office of Inspector General
CHAPTER 5. An Overview of Intellectual Property for the Healthcare Law Practitioner Basis of U.S. Intellectual Property Rights
The Bayh-Dole Act of 1980
The "Clinical Trial" Exception to Patent Infringement
Madey v. Duke University
The CREATE Act of 2004
The Patent "Troll" Phenomenon
CHAPTER 6. Information Management in Clinical Trials Privacy and Confidentiality and the Related Challenges Associated with Information Management
Information Management - Sources of Protection
Accounting for Research Disclosures
CHAPTER 7. Insurance Coverage for Clinical Trial Services General Concepts and Funding for Clinical Trials
Medicare Coverage for Clinical Trials
Specific Criteria for Medicare Coverage of Clinical Trials
Medicare Coverage for Medical Device Trials
Landmark Case - The Rush Settlement
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Clinical trials play an essential part in the advancement of healthcare in the United States and abroad. They are designed to evaluate, using human subjects, the safety and efficacy of new drugs, devices, treatments, or preventative measures. As health law and life sciences continue to overlap, those who represent healthcare entities need a better understanding of that interrelationship, and we believe the Clinical Research Practice Guide will deliver that.
This new publication discusses the development of human subject protections, the federal approval process for pharmaceuticals, medical devices, and biologics, including investigational new drug applications (IND), new drug applications (NDA), abbreviated new drug applications (ANDA), medical devices, and biologics. It also provides an introduction to the intellectual property considerations for healthcare attorneys includes not only an extensive discussion of the basics of intellectual property rights in the United States, the patent application process, patent infringement allegations, and an institutional intellectual property checklist, sample clauses.
The publication also provides chapters on information management, accounting for research disclosures, and critical components of reimbursement. The discussion includes coverage of the Civil False Claims Act and the Federal Anti-kickback statute, the Stark regulations, and the landmark settlement between the federal government and Rush University Medical Center for overpayments received by the hospital.
Health Lawyers commends this new publication to all involved with healthcare entities that are involved with clinical trials, or contemplating involvement in the future.