How is the FDA widening the scope of the Reagan Udall Expanded Access Navigator to assist patients with rare or orphan diseases?
Patients with rare diseases face unique challenges. Often, there may be no FDA approved treatments for them, or the patient population with an orphan disease is very small – it may be difficult to find [...]
Today is Giving Tuesday - a day to remember that much of the good in the world is undertaken by not-for-profit organizations. WCG Foundation's goals in expanded access, ethical training for medical research professionals, and [...]
For heart attack patients unwilling to enroll in traditional rehabilitation programs, what could be a good alternative?
The American Heart Association has recently reported a study in which patients who have suffered a heart attack, and were unwilling or unable to enroll in cardiac rehabilitation programs, had success with tai chi. Those [...]
The NIH and a consortium of biotechnical companies have created PACT, or the Partnership for Accelerating Cancer Therapies, to encourage the development of new immune based treatments for cancer. In some types of cancer, immunotherapies [...]
As patients who are receiving treatments via expanded access for diseases are outside of the controlled environment of a clinical trial, their experiences may be considered to be more "real-world." A multi-national chart review has [...]
Recent research of stem cells in mice has produced a more precise way to deliver chemotherapy to the tumor microenvironment of metastatic cancer. As opposed to targeting cancer cells directly, as other stem cell research [...]
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 [...]