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Biopharmaceutical Industry Committed to Discovery and Development of New Therapies for Patients Despite Challenges

Pharma: 07.25.14 Mental health conditions affect 1 in 4 Americans and take a heavy economic toll on the United States. Efforts to find effective treatments for conditions such as anxiety, depression, schizophrenia and substance abuse disorders continue despite difficult hurdles and setbacks. Researchers face a number of challenges in finding new treatments for mental illnesses — including […]

FDA Sentinel: Catching Biopharmaceutical Sponsors by Surprise

Applied Clinical Trials Online: Jul 24, 2014 The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects. During an update on The Future of FDA’s Drug Safety Program,Andrew C. von Eschenbach stated, “The full magnitude of some potential […]

Outdated Regulations Prohibit Sharing of Scientifically Accurate Information to the Detriment of Patient Care

Phrma: 07.22.14 In May, the U.S. House Energy and Commerce Committee launched the 21st Century Cures initiative to speed the discovery, development, and delivery of new treatments and cures for patients.  The Committee is conducting a series of hearings and has released white papers on a range of topics to solicit input from patients, researchers, and leaders in government and […]

African American Women’s Perceptions and Attitudes Regarding Participation in Medical Research: The Mayo Clinic/The Links, Incorporated Partnership

Journal of Women’s Health: July 21, 2014 Objective: To examine perceptions and attitudes toward health-related research participation among professional African American women. Methods: Participants were members of an African American women’s service organization, The Links, Incorporated. Data were collected via self-administered questionnaires at The Links, Incorporated 2012 National Assembly. Sociodemographics, prior research experience, intention to participate (ITP), […]

Medical Research: It’s about you and me

Research America: July 21, 2014 Research!America’s newest fact sheet series highlights the personal stories of medical research and the importance of increasing the NIH budget in FY15. We hope you will share these fact sheets with your representatives or congressional candidates, or take it with you on Hill or in-district visits. No one who reads […]

The Personal Experience of a Clinical Trial Patient

Clinical Trials Magazine: July 21, 2014 I have been working in clinical research for over ten years. I was originally based in a Phase I Clinical Trials Unit but later moved to the NHS. After working in a number of clinical roles with patients, I now work in GCP Quality Assurance. It is my job […]

Join the ‘I’m In’ campaign

Join the ‘I’m In’ campaign

AJC: Wednesday, July 16, 2014 By Gary Puckrein Whether you’ve taken a medication today to manage a chronic disease or simply keep a headache at bay, you know that medical innovations have the power to change lives. But these breakthroughs don’t just happen. Developing new medicines is a lengthy and complex process, relying heavily on […]

Will Black People Ever Trust Clinical Trials?

Ebony: JULY 16, 2014 Dr. Danielle N. Lee on the complicated need for Blacks to trust science…and for researchers to earn that trust Writer Evette Dionne recently penned a very personal yet important article about her own HPV diagnosis for Bustle. Dionne calls attention to a reality in health science research – the lack of adequate research on health […]

Guidance for IRBs, Clinical Investigators, and Sponsors 1

FDA.GOV:  July 2014   Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors This guidance is intended to provide information to institutional review boards (IRBs), clinical investigators, and study sponsors about FDA’s informed consent regulations. This guidance, when finalized, will supersede “A Guide to Informed Consent,” issued in September 1998, by the Office of […]