July 2008 – The CenterWatch Monthly : Volume 15, Issue 6, June 2008
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 end points.
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.
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 theEuropean 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 EuropeanForum for Good Practice (EFGCP), European Clinical ResearchInfrastructure Network (ECRIN), European Organisation for Research andTreatment of Cancer (EORTC), Hospital Clinic I Provincial deBarcelona 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.
- Month in Review
- In the Pipeline
- Opportunities Underway