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 has shown how some genes are turned off and on. Previously, such information was not available at this scale. However, [...]
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 treatments. The Food and Drug Administration's Center for Drug Evaluation and Research and their Center for Biologics Evaluation and Research combined [...]
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 another treatment, often for a more common disease, through the regulatory process more quickly. How does this program work? http://bit.ly/2f5RXjm
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 several variables. Some similarities, such as requests for background information, arose in both populations. But differences in requests for amenities such [...]
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. The reasons for the quick metastasis have been unknown. However, parents who lost their child gave a generous donation of [...]
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 between nonprofit organizations and the National Cancer Moonshot. The goal is to create a program that can be replicated throughout [...]
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 trials are being held. In addition, many pharmaceutical companies are researching similar drugs, meaning there can be significant competition for [...]
In addition to its current grants to support travel, lodging and living expenses to enable research professionals from resource-poor countries to study research ethics and management, WCGF has expanded grant opportunities to include grants for salary support and Master's Theses and Doctoral Dissertations. Through the salary support grants, WCGF aims to assist faculty members in [...]
The reasons minority participants avoid clinical trials are well documented. Historical lack of consent, little diversity within the research team, and a percieved lack of relevance could all seem to push patients away. But researchers are working with community leaders, introducing trial navigators and working with doctors who have many patients from minority communities are [...]
The Food & Drug Administration (FDA) has recently released a Manual of Policies and Procedures (MAPP) for the use of an investigational drug in an emergency - whether during or outside business hours. Because of the urgent nature of these requests, the FDA reviews the applications as soon as they're received. Also, because this process [...]