Clinical Trials
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This site provides links to websites listing information about clinical trials undertaken by manufacturers
of prescription drugs.
Maine law requires manufacturers or labelers of prescription drugs to list information on clinical
trials on prescription drugs that have been FDA-approved for marketing and are (or have been) dispensed,
administered, delivered or promoted in Maine. Certain registration and results information must be
posted on clinical trials conducted or sponsored by the manufacturer on or after October 15, 2002.
The date by which the information must be posted varies depending on when the trial occurred and when
the drug first enters Maine. Please note that the links below may not contain all clinical trials of
a drug. For example, a trial conducted by an entity that is not a manufacturer or labeler would not
be subject to this Maine law.
The Maine law, entitled"An Act Regarding Advertising by Drug Manufacturers and Disclosure
of Clinical Trials," imposes other responsibilities on drug manufacturers.
- Letters to Prescription Drug Manufacturers:
- Advisory RE Clinical Drug Trial Reporting – October 24, 2008 Word*
| PDF*
- Advisory RE Clinical Drug Trial Reporting – March 30, 2009 Word*
| PDF*
- Clinical Trials Reporting Update – September 2008 Word*
| PDF*
- Additional Information on the Implementation of Maine's new law (updated March 2006) Word*
| PDF*
- Original letter: Word*
| PDF*
- Clinical Trial Rules
- Adoption of Final Rules
- A
joint rule between the Department of Health and Human Services, 10-144, Chapter 275, Section
1, and Office of Attorney General, 26-239, Chapter 111 - Prescription
Drug Clinical Trial Reporting Word*
- Chapter 605
- Information on drug safety and recalls:
Maine Advisory Regarding FDA Concerns About Posting of Drug Trial Results and Promotion Word*
| PDF*
Manufacturers or labelers having a particular difficulty complying with Maine clinical drug trial
reporting requirements should contact the State of Maine regarding the particular issue. The State
will entertain a compliance plan in some circumstances. Communication should be to: Thomas Bradley,
Assistant Attorney General, Maine Office of Attorney General, 6 State House Station, Augusta, ME 04333,
or by email to Thomas.Bradley@Maine.gov.
Clinical trials and results for the following Manufacturers can be found at
Name of Manufacturers:
- Abbott
- Alkermes
- Allergan
- Amylin
- Astellas Pharma Inc.
- Braintree
- Bristol Myers Squibb
- Cubist Pharmaceuticals, Inc.
- DEY, L.P.
- Eisai Medical Research, Inc
- Jazz Pharmaceuticals
- Johnson & Johnson
|
- MedImmune, LLC
- Merck
- PAR Pharmaceutical
- Pfizer
- Procter & Gamble Pharmaceuticals
- Sanofi Aventis
- Sepracor, Inc.
- Solstice Neuroscience, Inc.
- Tap Pharmaceutical Products Inc.
- UCB Inc.
- Wyeth
|
Resources:
Amgen
This site contains information about clinical trials sponsored by Amgen. |
Bristol-Myers Squibb
This site contains information about clinical trials sponsored by Bristol-Meyers Squibb. |
Lilly Trials
This site contains information about clinical trials sponsored by Eli Lilly and Company. |
Centerwatch
The CenterWatch Clinical Trial Results Database is a new reference resource for patients,
their advocates and for health professionals. |
Roche Trials
This site contains information about clinical trials sponsored by Roche. |
Forest Clinical Trials
This site contains information about clinical trials sponsored by Forest Clinical Trials. |
Novartis
Clinical Trials
This site contains information about clinical trials sponsored by Novartis. |
Sanofi
Aventies
This site contains information about clinical trials sponsored by Sanofi Aventies. |
Boehringer Ingelheim
This site contains information about clinical trials sponsored by Boehringer Ingelheim. |
Astrazeneca Clinical Trials
This site contains information about clinical trials sponsored by Astrazeneca. |
| |
Ligand
Ligand is an early-stage biotech company that focuses on discovering and developing new drugs
that address critical unmet medical needs in the areas of thrombocytopenia, cancer, hepatitis
C, hormone-related diseases, osteoporosis and inflammatory diseases. |
Organon
Organon is a global leader in the creation of innovative prescription medicines for gynecology,
fertility, neuroscience and anesthesia. |
Genzyme Clinical Research
Genzyme's clinical research program is focused on the areas of medicine where it markets commercial
products, namely rare inherited disorders, kidney disease, orthopaedics, cancer, transplant
and immune diseases, and diagnostic testing. |
Glaxo Smith Kline
The GlaxoSmithKline (GSK) Clinical Trial Register provides
an easily accessible repository of data from GSK-sponsored clinical trials, supplementing communications
in journals, at scientific meetings, in letters to healthcare professionals and in approved
prescribing information. |
Sepracor
Sepracor lists their clinical trial results on ClinicalStudyResults.org |
Bayer Healthcare
Bayer Healthcare database. |
Novo Nordisk
This site contains information about clinical trials sponsored by Novo Nordisk. |
Gilead Sciences
The purpose of this clinical trial results database is to make objective, scientific information
about clinical trials conducted by Gilead Sciences, Inc. publicly available in a standard,
summarized format. |
Allergan, Inc
Allergan, Inc. is a global specialty pharmaceutical company that is driven by technology and
innovation. |
Solvay
Pharmaceuticals, Inc
Solvay Pharmaceuticals is perpetually engaged in the process of developing and testing new
treatment options in the areas of cardiology, gastroenterology, mental health, women’s
health and specialized markets. |
| |
Contact:
Jennifer Cook
Pharmacy Unit, Office of Maine Care Services
jennifer.cook@maine.gov
