FDA to Examine Inclusion of Subpopulations in Clinical Trials
The Food and Drug Administration (FDA) announced that it will hold a hearing to obtain input on the issues and challenges associated with the collection, analysis, and availability of demographic subgroup data (i.e. sex, race/ethnicity, and age) in applications for approval medical products. The hearing will take place on April 1, 2014 from 9:00am-3:00pm at the FDA White Oak Campus (10903 New Hampshire Ave, Silver Spring, MD). The FDA will solicit input at the hearing on approaches that might be used to encourage enrollment of subgroup participants in clinical trials. They will also look at appropriate sources of information to define disease prevalence in subgroups, best practices for establishing inclusion and exclusion criteria for clinical trials, and considerations for capturing, analyzing and communicating subgroup data to multiple audiences. Accelerate Cure/Treatments for Alzheimer’s Disease (ACT-AD) will be represented at this hearing. A public docket will remain open until May 16, 2014 for those interested in commenting after the hearing. It can be accessed via the following link: https://www.federalregister.gov/articles/2014/03/04/2014-04625/action-plan-for-the-collection-analysis-and-availability-of-demographic-subgroup-data-in
Viewpoints of key stakeholders heard at the meeting and received through the docket will inform FDA’s process for developing an action plan on the extent to which clinical trial participation and safety and effectiveness data by demographic subgroups is included in applications submitted to FDA. This action plan was required by the Food and Drug Administration Safety and Innovation Act (FDASIA).
Attendance at the hearing is free but registration is required. The event will also be available via webcast. For more details and to register, click here.
Health Affairs: The Long Reach of Alzheimer’s Disease
The April 2014 issue of Health Affairs is a thematic issue titled The Long Reach of Alzheimer’s Disease. The special issue will explore many important topics raised by this disease such as how to provide optimal care to dementia patients; how Alzheimer’s disease treatment varies internationally, and how public-private research collaborations can lead to more effective treatments. The thematic issue was made possible with support from Accelerate Cure/Treatments for Alzheimer’s Disease (ACT-AD), Eli Lilly and Company, Janssen Research & Development, and the Alzheimer’s Association.
The Long Reach of Alzheimer’s Disease will be unveiled at a briefing on April 9, 2014 from 8:30 am-12:30 pm at W Hotel in Washington, DC (515 15th Street NW). Panels during the briefing will highlight research challenges and methods of delivering care and support to people with dementia and their caregivers. Dr. Richard Hodes, Director of the National Institute on Aging at the National Institutes of Health will deliver the keynote address at the event.
The briefing is free and open to the public. For more details on the event and to register, click here.
NIBIB Director to Host Seminar on Technological Advances
The National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of the National Institutes of Health, supports research that integrates engineering and the physical and life sciences to transform medicine. Dr. Roderic Pettigrew, Director of the NIBIB, invites patient advocates to a seminar at the NIH campus on Friday, April 25, 2014 from 10:00 a.m. to 11:30 a.m. to hear about some of the remarkable research being developed by NIBIB grantees and intramural research scientists. The seminar will include hands-on demonstrations for participants to see, feel, and experience the technological advances being made with NIBIB support.
The NIBIB strives to improve health by leading the development and accelerating the application of biomedical tools and technologies that can see inside the body without being invasive, make diagnoses at the time of examination, help precisely guide and monitor the delivery of therapies, and improve our understanding of disease. With this new knowledge scientist will be able to develop the next generation of tools and technologies that are smaller, faster, cheaper, and more effective, vastly improving health care for all.
There is no fee participate in the seminar. To attend, please RSVP to Kate Egan ([email protected]) by April 18, 2014.
ACT-AD Chair to Screen Pocket Films at French Embassy
The Alliance for Aging Research has developed a series of animated pocket films on Alzheimer’s disease in partnership with David Shenk, noted author of The Forgetting. These five short films are narrated by David Hyde Pierce and their purpose is to provide a better understanding of Alzheimer’s disease, reduce stigma, improve care, and help the search for a cure. Originally developed in English, these films have been translated into 14 languages.
The Alliance for Aging Research is screening these pocket films during a cocktail reception held at the Embassy of France (4104 Reservoir Rd., NW, Washington, DC) on April 24, 2014 from 6:00 pm-8:00 pm.
The event is free but registration is required. Please RSVP to Sarah DiGiovine at [email protected].
GE Launches MIND App for Patients and Caregivers
This month, GE Healthcare launched a second online initiative under its Make an Impact on Neurological Disorders (MIND) Campaign. The GE MIND app, newly available for iPads on iTunes, is designed to educate users about the benefit of art and music for people with neurological diseases such as Alzheimer’s disease, Parkinson’s disease and brain trauma. Art and music can evoke strong emotional responses, which may persist longer than the memory of the experience. Research also suggests that listening to music can have some benefit to people who have Alzheimer’s disease by relieving stress, and by reducing anxiety, depression and agitation. The MIND app helps patients and caregivers connect – emotionally, physically, and interactively. Most importantly, the MIND app is fun, stimulating, and creates an important vehicle for expression for those affected by neurological diseases.
The MIND app is free and can be downloaded at iTunes.