First Clinical Research Milestones
- 2005: Journal of Clinical Research Best Practices publishes first issue.
- 2005: World Health Organization (WHO) specifies “Minimal Registration Data Set” for registering clinical trials.
- 2006: TeGenero's Phase I study of monoclonal antibody TGN1412 for treating inflammatory diseases injures six study participants by triggering a massive cytokine release.
- 2007: D.C. Circuit Court affirms district court ruling in the Abigail Alliance case that there is no fundamental right of access to experimental drugs for the terminally ill.
- 2007: Food and Drug Administration Amendments Act (FDAAA) expands registry requirement to all clinical trials (except Phase I), gives FDA enforcement power over post-marketing commitment studies, and allows FDA to require a Risk Evaluation and Mitigation Strategy (REMS) for drugs associated with greater safety risks.
- 2008: FDA's Office of Critical Path Programs announces the Clinical Trials Transformation Initiative (CTTI), a public-private partnership to improve the quality and efficiency of clinical trials.
- 2010: Congress enacts Patient Protection Affordable Care Act, including the Physician Payment Sunshine Provision, which requires, among other things, that clinical investigators disclose financial compensation in excess of $10 from pharmaceutical and medical device companies.
- 2010: Havasupai Tribe v. Arizona State University Board of Regents case settles, highlighting group risks in clinical research.
- 2011: President’s Bioethics Commission for the Study of Bioethical Issues publishes report, "'ETHICALLY IMPOSSIBLE' STD Research in Guatemala
from 1946 to 1948," on its investigation of U.S. Public Health Service clinical research.
- 2014: The Goldwater Institute, a public policy advocacy and research organization, puts forth model Right-to-Try legislation that attempts to give terminally ill patients, who have “nothing to lose,” the opportunity to try an unproven and possibly dangerous treatment that might save or prolong their life. Later that year, Colorado is the first state to pass right-to-try legislation.
- 2016: Bial's Phase I study of BIA 10-2474, a potential treatment for pain and anxiety, kills Guillaume Molinet and causes brain damage to four other study participants.
- 2017: DHHS and 15 other federal agencies publish revisions to the Common Rule.
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