Could wider inclusion of minority patients in clinical trials actually lower the cost of healthcare overall?
Lack of accurate data regarding potential side effects or differences in effectiveness in treatments between white Americans and patients of different ethnic backgrounds often leads to less affordable options of care. When drugs have been [...]
New Waiver in IRB Process Speeds FDA Single Patient Expanded Access Approval; Updated Information available on WCGF website.
On October 3, 2017, Dr. Scott Gottlieb, FDA Commissioner, testified before the US House of Representatives Subcommittee on Health, Committee on Energy and Commerce. He announced a significant change to the way that IRB may [...]
How could a new treatment, given previously under expanded access, successfully treat a serious disease of the eye?
A treatment for neurotrophic keratitis, initially given under expanded access, has been approved for use in European countries. The treatment, a genetically engineered nerve growth factor, has been shown to heal the corneas of affected [...]
Researchers funded by the National Institutes of Health (NIH) have completed an atlas of human DNA that influence gene expression. Gene expression is shown through observable traits like eye color or disease risk; this research [...]
Expanded access allows patients to receive innovative new drugs. How often does the FDA approve patients’ requests?
The FDA's expanded access program has allowed many desperately ill patients to receive experimental treatments in an effort to save lives. Just last fiscal year, over 1,700 requests were made by patients to access experimental [...]
What is a .@US_FDA priority review voucher and how does it expand opportunity for #medicalresearch of #rarediseases?
The priority review voucher program incentivizes pharmaceutical companies to research drugs for very rare diseases. When a drug developer researches a rare disease, a voucher is received by that organization from the FDA to move [...]
What kind of information can be gained from a mock clinical trial? How can this procedure help us learn about diversifying clinical trials?
Two populations in the United States - one in Altoona, Pennsylvania, the other in Atlanta, Georgia - of similar incomes, but different racial backgrounds, were enrolled in a mock clinical trial to gauge participation given [...]
Michelle Monje, MD, PhD, is a researcher studying a rare type of pediatric brain tumor, Diffuse Intrinsic Pontine Glioma (DIPG). This type of cancer often spreads quickly and the patient dies only months after diagnosis. [...]
iMPACT is a three-year pilot program focusing on the recruitment and retention of minorities in cancer clinical trials. Its aim is to remove barriers and improve access to cancer-related clinical trials and is a partnership [...]
How is it possible that a great many promising cancer drugs create a problem for research and trials?
There are many new immunotherapeutic drugs for cancer in the research pipeline. Too few patients are available to fill the clinical trials, as many are receiving treatment from physicians outside of the research institutions where [...]