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 [...]
Though the cells from breast cancer tumors of African American women and white women have an overwhelming number of similarities, aggressiveness of tumors and outcomes of the disease are drastically different. African American women are much more likely to be diagnosed at a younger age, and are more likely to have more aggressive types of [...]
How many types of cells are in the human body? Two hundred? More? A researcher found a new way to take a census of cells.
There are around 37 trillion cells in the human body. But those can be categorized into how many types? A simple Google search will yield a result of about 200, but some researchers, including Jay Shendure, a geneticist at the University of Washington, think that number is quite low. Therefore, Dr. Shendure has created a [...]
How can patients, who often don’t enroll in clinical trials because they are far from home, join trials that could save their lives?
As the ubiquity and growing dependability of online communication grows, telemedicine has proven to be a boon for patients, especially those in rural areas where the number of physicians is dwindling. And, as discoveries in the lab have been leading to promising medical treatments, the supply of patients hasn’t been able to meet the demand [...]
What is expanded access and how can a desperately ill patient find treatment through this process? Are there online tools available for navigating the steps needed?
Expanded access, also known as compassionate use, is a process by which a patient can petition both the maker of an experimental treatment and the US Food and Drug Administration for access to the treatment outside a clinical trial. The Regan-Udall Foundation has created an Expanded Access Navigator to educate patients and their physicians about [...]
A new study from Bioethics International shows that a majority of drugs provided to very ill patients via the Food and Drug Administration's (FDA) expanded access program - 76% - eventually gain marketing approval from FDA. However, few safety and efficacy data from expanded access uses are reported to the public before such approval. http://prn.to/2vtgDeN
Leading cancer organizations have formed a coalition and provided recommendations to extend better care to minorities. What do they suggest?
A summit attended by healthcare experts and representatives from the National Institutes of Health (NIH), American Cancer Society, the American Society for Cancer Research (ASCR), and American Society of Clinical Oncology (ASCO) convened, producing a list of recommendations to extend better cancer screening and care to currently underserved minority populations. Among the recommendations is to [...]
The Reagan-Udall Foundation Navigator: An Online Tool to Help Desperately Ill Patients Considering Compassionate Use Treatment Options
Expanded access, also known as compassionate use, is a process by which a patient can request both the manufacturer of an experimental product (treatment) and the US Food and Drug Administration for access to the treatment outside of a clinical trial. Desperately ill patients, family caregivers and treating physicians often consider this option, but navigating [...]
A 2015 study demonstrates a continuing, significant lack of participation among minorities in clinical trials in the US. This is the case even though more than 70% of Americans stated that, if advised by their physicians, they would participate in a clinical trial. The importance of participation is critical because individuals of different race, ethnicity [...]
Good science is based on sound research design and ethical basis, competent researchers and high quality, transparent and reproducible data. With the significant and swiftly occurring advances being made in technology, science and medicine, good science, coupled with sound research ethics, is critical to research participants and ultimately, the public. While many in the research [...]