The News Review:
- ACR Comments on NEJM Article on Globalization of Clinical Research
- Questions f Ethics Quality Cloud Globalization f Clinical Trials
- Transparency Globalization Growing in Clinical Research Enhanced …
ACR Comments on NEJM Article on Globalization of Clinical Research
PR Newswire (press release) NY -
A well-trained global investigator network is in the best interest of all participants in the drug development process. However the globalization of the clinical trials enterprise is a complex endeavor involving many factors. Unfortunately the authors’ ignored one of the primary drivers behind the globalization of clinical research: the limited participation rate in clinical trials in the United States and Western Europe. According to the non-profit Center for Information & Study on Clinical Research Participation 80% of clinical trials in the United States are delayed at least one month because of unfulfilled enrolment. The ramifications of this limited participation are clear. According to the National Cancer Institute fewer than 5% of cancer patients participate in clinical trials; but if the participation rate doubled to just 10% studies could be completed in one year rather than the typical three-to-five years. ACR and its members work extensively to increase clinical trial participation in the U.
Related from Indoorenvirons: StemCells Inc. Comments on PLoS Medicine Article Concerning Cell …
Questions f Ethics Quality Cloud Globalization f Clinical Trials
eMaxHealth.com NC -
-based pharmaceutical companies are moving their clinical trials overseas at warp speed raising questions about ethics quality control and even the scientific value of their findings for people back in the U. Many of the trials are taking place in developing countries in Eastern Europe and Asia where study participants are often poorer and less educated than are study participants in the U. according to researchers at Duke Clinical Research Institute (DCRI). “The FDA is supposed to provide oversight for such trials but it simply wasn’t designed to handle this kind of situation” says Kevin Schulman MD the senior author of the report appearing in the New England Journal of Medicine. Schulman says the number of Food and Drug Administration investigators based outside the U.
Transparency Globalization Growing in Clinical Research Enhanced …
Modern Medicine NJ -
19 (HealthDay News) — All clinical trial data and the U. Food and Drug Administration database should be publicly available and global clinical research should be conducted in relevant populations for potential applications of the intervention according to two articles published in the Feb. 19 issue of the New England Journal of Medicine. In the first article Alastair J.
