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 studied, and minorities left out, treatments that are less effective could lead to greater numbers of hospitalizations, driving up the [...]

2017-11-07T12:22:35+00:00November 10, 2017|General|

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 review single patient expanded access request involving investigational drugs or biologics. This change, which permits an IRB chair or designee [...]

2018-05-25T16:30:55+00:00November 8, 2017|General|

What can a new atlas of DNA tell us about genetic probabilities?

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, [...]

2017-11-07T12:22:28+00:00November 3, 2017|General|

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 [...]

2017-09-27T06:08:43+00:00October 31, 2017|General|

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?

2017-09-27T06:08:35+00:00October 27, 2017|General|

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 [...]

2017-09-27T06:08:29+00:00October 24, 2017|General|

What information can the donation of one patient’s tumor yield about metastasis?

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 [...]

2017-09-27T06:08:21+00:00October 20, 2017|General|

What is the iMPACT Program and how will it bring diversity to clinical trials?

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 [...]

2017-09-27T06:08:14+00:00October 17, 2017|General|

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 [...]

2017-09-27T06:08:04+00:00October 13, 2017|General|
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