Clinical Research Milestones

300+ milestones in clinical research.  Milestones wanted!

• 2000: Department of Health and Human Services transfers Office for Protection from Research Risks from National Institutes of Health to Office of the Secretary, and renames it the Office for Human Research Protections
• 2000: National Coverage Decision provides for Medicare coverage of “routine” costs of “qualifying” clinical trials.
• 2000: World Health Organization (WHO) issues "Operational Guidelines for Ethics Committees That Review Biomedical Research."
• 2000: World Medical Association, in a meeting in Edinburgh, expands on the Declarations of Helsinki and Tokyo by prohibiting the use of placebo controls when there is a known effective treatment. Subsequent clarification removes the prohibition.
• 2001: After Ellen Roche dies during an asthma drug study, Office for Human Research Protections suspends all Federally-funded clinical research at Johns Hopkins University School of Medicine and affiliated institutions. At the time, Johns Hopkins University was the leading recipient of Federal research funding.
• 2001: Association for the Accreditation of Human Research Protections Programs (AAHRPP) is established.
• 2001: Clinical Trials Directive (European Union Directive 2001/20/EC) simplifies and harmonizes (“approximates”) administrative provisions governing clinical trials in the European Union.
• 2001: Health Insurance Portability and Accountability Act requires privacy and security for personal health information.
• 2001: In the cases of Ericka Grimes and Myron Higgins v. Kennedy Krieger Institute, relating to a research study on the prevention of lead poisoning among inner-city children, Maryland Court of Appeals rules that parents cannot consent to participation by their children “in nontherapeutic research or studies in which there is any risk of injury or damage to the health of the subject.”
• 2002: Animal Efficacy Rule authorizes FDA to approve drugs based on animal test results if human testing is not practical because the drugs prevent or ameliorate “serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic biological, chemical, radiological, or nuclear substances.”
• 2002: Best Pharmaceuticals for Children Act provides six-month patent extension for manufacturers who conduct pediatric trials.
• 2002: Medical Device User Fee and Modernization Act authorizes user fees for FDA premarket reviews.
• 2002: Pharmaceutical Research and Manufacturers Association (PhRMA) adopts “Principles on Conduct of Clinical Trials.”
• 2002: Time Magazine (April 22) publishes cover story by Michael D. Lemonick and Andrew Goldstein, titled, “Human Guinea Pigs: Some patients join clinical trials out of desperation. Others to help medicine advance. Whom do you blame if they get sick – or even die?”
• 2003: American Association for Cancer Research removes the name of Cornelius P. Rhoads from its annual award given to young cancer investigators, because it came to its notice that at least 13 Puerto Rican subjects had died in the 1930s after Dr. Rhoads injected them with cancer cells. Dr. Rhoades also made highly racist remarks about the inhabitants of Puerto Rico.
• 2003: FDA approves Bristol-Myers Squibb’s Pravigard PAC (pravastatin sodium and buffered aspirin) based on Bayesian data analysis.
• 2003: In Diaz v. Hillsborough County Hospital Authority lawsuit, class action plaintiffs settles case for $3.8 million in damages for “dignitary harm” that involves no physical harm.
• 2003: National Coverage Decision states that Medicare/Medicaid will cover certain costs associated with device trials.
• 2003: Pediatric Research Equity Act gives FDA authority to require pediatric studies of pharmaceutical products.
• 2003: Pfizer uses Bayesian methods to discontinue the adaptive ASTIN trial of treating stroke with neutrophil inhibitory factor (NIF), based on futility.