CenterWatch Monthly July 2008 Issue
Maine Moves First with Clinical Trial Transparency Law
Maine law now requires sponsor companies to publicly disclose information about most clinical trials of FDA-approved prescription drugs that are sold in Maine. Sponsors must document protocol details in a clinical trials registry and report results for key trial endpoints. About 45 pharmaceutical companies have complied with Maine’s law, but those companies and others have voiced serious concerns about how Maine’s law relates to federal requirements. The federal trial results database will preempt the Maine law, but Maine regulators insist that won’t be fully in place until at least 2010. In the intervening years, sponsors will have to be aware of what transparency regulations Maine and dozens of others states are implementing.
Regulatory and Ethical Issues in Gene Therapy Research
Scientific advances, including gene therapy research, often push the envelope on issues such as informed consent, continuing oversight, reporting serious adverse events, conflict of interest and determining risk versus benefit. There have been a number of changes in the government’s regulatory oversight of gene therapy trials. The unexpected death of a participant in a gene therapy trial in 2007 resulted in renewed scrutiny of these protocols and the approval process that allows them to go forward. To further advance the possibilities of treating cancers and other diseases, subjects who agree to enroll in gene therapy trials must be protected from harm.
Impact on Clinical Research of European Legislation FP7 Project Underway
The Impact on Clinical Research of European Legislation (ICREL) project is funded by the European Commission’s Seventh Framework Programme (FP7) to measure and analyze the direct and indirect impact of the European Union Clinical Trial Directive 2001/20/EC and EU-related legislation on all categories of clinical research. The one-year ICREL project is being carried out by a consortium composed of the European Forum for Good Practice (EFGCP), European Clinical Research Infrastructure Network (ECRIN), European Organisation for Research and Treatment of Cancer (EORTC), Hospital Clinic I Provincial de Barcelona and the Ethics Committee of the University of Vienna.
Eye On: Ovarian Cancer
Most ovarian cancers are classified as ovarian epithelial carcinomas, which originate from cells on the ovarian surface, or malignant germ cell tumors that originate from egg cells. According to the National Cancer Institute, there are 21,650 estimated new cases of ovarian cancer in the United States in 2008, and 15,520 deaths, making it the fourth most common cause of female cancer death.
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