Think Tank
The History of trial acceleration
This timeline contains Trial Acceleration Milestones and Regulatory Milestones.
A Trial Acceleration Milestone is a landmark event that provided significant improvements to Clinical Trial processes.
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This timeline contains Trial Acceleration Milestones and Regulatory Milestones.
1980
Trial Acceleration Milestones:
Baltimore Phase I Unit
Baltimore Phase I Unit begins advertising clinical trial opportunities on local radio – J. Needham
Tufts Center for the Study of Drug Development
Founded in 1976, Tufts Center for the Study of Drug Development introduces comprehensive metrics and analysis to drug development cycle times. - M. Hovde
1981
Regulatory Milestones
Revised Regulations for Human Subject Protections
FDA and the Department of Health and Human Services revise regulations for human subject protections, based on the 1979 Belmont Report. The revised rules provide for wider representation on institutional review boards and they detail elements of what constitutes informed consent, among other provisions.
1982
Trial Acceleration Milestones:
Quintiles
Quintiles is incorporated in NC - M. Hovde
Regulatory Milestones
Tamper-Resistant Packing Regulations
Tamper-resistant Packing Regulations issued by FDA to prevent poisonings such as deaths from cyanide placed in Tylenol capsules.
1983
Regulatory Milestones
Orphan Drug Act
Orphan Drug Act passed, enabling FDA to promote research and marketing of drugs needed for treating rare diseases.
1984
Regulatory Milestones
Drug Price Competition and Patent Term Restoration Act
Drug Price Competition and Patent Term Restoration Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without repeating the research done to prove them safe and effective.
1985
Regulatory Milestones
AIDS Test
AIDS test for blood approved by FDA in its first major action to protect patients from infected donors.
1986
Regulatory Milestones
Childhood Vaccine Act
A Childhood Vaccine Act requires patient information on vaccines, gives FDA authority to recall biologics, and authorizes civil penalties.
1987
Regulatory Milestones
Investigational Drug Regulations Revised
Investigational drug regulations revisedto expand access to experimental drugs for patients with serious diseases with no alternative therapies.
1988
Regulatory Milestones
Food and Drug Administration Act of 1988
Food and Drug Administration Act of 1988 officially establishes FDA as an agency of the Department of Health and Human Services.
1989
Regulatory Milestones
FDA Issues a Nationwide Recall
FDA issues a nationwide recall of all over-the-counter dietary supplements containing 100 milligrams or more of L-Tryptophan.
1990
Regulatory Milestones
Congress passes the Anabolic Steroid Act
Congress passes the Anabolic Steroid Act of 1990. Nutrition Labeling and Education Act requires all packaged foods to bear nutrition labeling and all health claims for foods. Safe Medical Devices Act is passed, requiring nursing homes, hospitals, and other facilities that use medical devices to report to FDA incidents that suggest that a medical device probably caused or contributed to the death, serious illness, or serious injury of a patient.
1991
Regulatory Milestones
Regulations Published to Accelerate the Review of Drugs
Regulations published to Accelerate the Review of Drugs for life-threatening diseases. Common Rule: This rule issues requirements for researchers who obtain and document informed consent.
1992
Regulatory Milestones
First book on patient recruitment
Spilker and Cramer co-author first book on patient recruitment underscoring site challenges. - G. Sweet
Generic Drug Enforcement Act
Generic Drug Enforcement Act imposes debarment and other penalties for illegal acts involving abbreviated drug applications. Prescription Drug User Fee Act requires drug and biologics manufacturers to pay fees for product applications and supplements, and other services.
1993
Regulatory Milestones
MedWatch
A consolidation of several adverse reaction reporting systems is launched as MedWatch, designed for voluntary reporting of problems associated with medical products to be filed with FDA by health professionals. Revising a policy from 1977 that excluded women of childbearing potential from early drug studies, FDA issues guidelines calling for improved assessments of medication responses as a function of gender. Companies are encouraged to include patients of both sexes in their investigations of drugs and to analyze any gender-specific phenomena.
1994
Regulatory Milestones
Butler Clinical Recruitment
The CRO, PPD organizes what would become Butler Clinical Recruitment (now owned by Quintiles) and Pharmaceutical Research Plus to recruit 3,600 GI patients in 6 weeks using TV, radio and print and centralized screening. ñ S. Ballenger Uruguay Round Agreements Act extends the patent terms of U.S. drugs from 17 to 20 years.
1995
1996
1997
Regulatory Milestones
Wide-Ranging Reforms in Agency Practices
Food and Drug Administration Modernization Act reauthorizes the Prescription Drug User Fee Act of 1992 and mandates the most wide-ranging reforms in agency practices since 1938.
1998
Regulatory Milestones
Internet clinical trial recruiting begins
Internet clinical trial recruiting begins, with companies like Acurian, Veritas Medicine, HopeLink, and others learning to harness the Internet to identify and communicate with patients and sites. - J. Hollway
Radiant Research founded. - M. Hovde
FDA Promulgatess the Pediatric Rule
FDA promulgates the Pediatric Rule, a regulation that requires manufacturers of selected new and extant drug and biological products to conduct studies to assess their safety and efficacy in children.
1999
Regulatory Milestones
ClinicalTrials.gov is founded.
ClinicalTrials.gov is founded.
2000
2001
Regulatory Milestones
Monitorforhire.com
Monitorforhire.com, the first Internet based resource management tool is launched. - S. Freedman
The use of eLearning and portal technology is identified as a solution to accelerate and improve the site selection, protocol training and study document completion process helping reduce cycle times and improve site performance. - L. Converse
2002
Regulatory Milestones
Pharmacy Data is Utilized
Pharmacy data is utilized in a HIPAA-compliant way to enroll patients for a diabetes trial - Acurian
The Best Pharmaceuticals for Children Act improves safety and efficacy of patented and off-patent medicines for children. In the wake of the events of September 11, 2001, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 is designed to improve the country's ability to prevent and respond to public health emergencies, and provisions include a requirement that FDA issue regulations to enhance controls over imported and domestically produced commodities it regulates.
2003
Regulatory Milestones
Acurian Uses Pharmacy Data to Specifically Target and Recruit Patients
Acurian uses pharmacy data to specifically target and recruit patients in HIPAA-compliant manner. - S. Ballenger
The Center for Information & Study of Clinical Research Participation is founded by Ken Getz. - M. Hovde
FDA is given clear authority under the Pediatric Research Equity Act to require that sponsors conduct clinical research into pediatric applications for new drugs and biological products. Health Insurance Portability and Accountability Act.
2004
Regulatory Milestones
Acurian Completes Second Program in Which Over 10,000 Patients
Acurian completes second program in which over 10,000 patients were screened using Direct-To-Patient outreach exclusively. - S. Ballenger
Project BioShield Act of 2004 authorizes FDA to expedite its review procedures to enable rapid distribution of treatments as countermeasures to chemical, biological, and nuclear agents. Vioxx withdrawal and COX-2 shakeup. FDA bans dietary supplements containing ephedrine.
2005
Regulatory Milestones
Formation of the Drug Safety Board is announced
Formation of the Drug Safety Board is announced, consisting of FDA staff and representatives from the National Institutes of Health and the Veterans Administration.
2006
2007
2008
2009
2010
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Submit a Trial Acceleration Milestone for 1980
A Trial Acceleration Milestone is a landmark event that provided significant improvements to Clinical Trial processes. If you were involved in one of these events, or know of one, please submit it with this form. Once it is reviewed by Trial Acceleration Institute, it may be included in our Timeline.
If your milestone is accepted, you will be contacted by a representative from Trial Acceleration Institute prior to posting your milestone.
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