Newsletter vol. 9 | FDA Office of Minority Health
2016: Year in Review
Year of Clinical Trial Diversity
In early 2016, FDA Commissioner Dr. Robert Califf launched the Year of Clinical Trial Diversity effort. We developed a complementary campaign, #ClinicalTrialsChampions, to amplify the message regarding the need for increased diversity in clinical trials. The campaign featured 6 PSA’s focused on increasing awareness of minority participation in clinical trials which were launched on World Sickle Cell Day. We also developed a comprehensive communications toolkit for stakeholders and the campaign generated 7.3 million impressions, 6,300 views, and a reach of 4 million via Thunderclap thanks to our loyal supporters like you.
Multilingual Outreach Workshop
Last May, OMH partnered with FDA's Office of External Affairs to host our first multilingual workshop. The workshop titled "Multilingual Outreach Strategy 101: What You Need to Know About Engaging Multilingual Audiences" was held at the FDA White Oak Campus and was available to the public via webcast. The workshop was conducted as part of OMH's leadership of the FDA Language Access Plan, an initiative to identify the needs of people with limited English proficiency (LEP) and to provide meaningful access to language-assistance services. Experts from the FDA, USAGov, and the Department of Justice shared information about using innovative techniques to deliver multilingual information to limited English proficiency populations.
Clinical Trials Symposium
In September, we partnered with the University of Miami to host a two-day seminar in Coral Gables. The symposium, “Improving Clinical Research in the Age of Precision Medicine,” focused on scientific, regulatory, and ethical aspects of clinical trials as well as quality assurance practices. It also provided important updates on FDA Regulatory requirements for clinical trials and perspectives from the front lines of clinical research. FDA Commissioner Dr. Robert Califf was the keynote speaker and our Assistant Commissioner for Minority Health, Dr. Jonca Bull, also gave a presentation. The event was extremely successful and more than 500 participants attended the event.
Health Disparities Research: OMH Research and Collaboration Program
Our Research and Collaboration Program worked with FDA centers and external partners to support research studies about minority health and health disparities over the past year. The program has an extramural and intramural research component. The program gained ground this year in studying medical conditions that disproportionately affect racial and ethnic subgroups and identified future directions for research and aiding regulatory decision-making.
Some of the research projects our intramural program funded include; Racial Disparities in Multiple Myeloma, Underutilization of Generic Medications in Underserved Patients, and Advertising and Promotional Labeling in Adult Immunization Disparities. The office also had multiple Centers for Excellence in Regulatory Research Science and Innovation (CERSI) projects with Georgetown University (Targeting triple negative breast cancer in African American women), University of California San Francisco/Stanford (Safer Labeling of Pediatric Medications: Reducing Literacy-related Health Disparities among Chronically Ill Adolescents), Johns Hopkins University (Workshop Clinical Trials: Assessing Safety and Efficacy for a Diverse Population). We also fund a genomics fellow at Harvard University School of Medicine.
Throughout 2016 our office hosted than half a dozen fellows and pharmacy students. Our students hailed from institutions such as Howard University, the University of Washington, and Florida Agricultural and Mechanical University.
FDA OMH DRAFT GUIDANCE WEBINAR - January 24, 2017
Join us on Tuesday, January 24, 2017 from 12:00 pm – 1:00 pm EST to learn about our recently released guidance document Collection of Race and Ethnicity Data in Clinical Trials-Guidance for Industry and FDA Staff. Speakers will include FDA Assistant Commissioner for Minority Health Dr. Jonca Bull and OMH's Dr. Martin Mendoza.
Last fall, the FDA Office of Minority Health (OMH) issued a draft guidance document to outline FDA's expectations for and recommendations on use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials for FDA regulated medical products conducted in the United States and abroad. The webinar will highlight the importance of the inclusion of appropriate populations in trials by sponsors, as well as the use of standard terminology for age, sex, gender, race, and ethnicity with the goal of ensuring that subpopulation data is collected consistently.
You can register and find more information about the webinar on the Eventbrite page. If you have any questions, please feel free to emails us at firstname.lastname@example.org
Ninth Annual Sentinel Initiative Public Workshop - February 2, 2017
The Food and Drug Administration is hosting a public workshop entitled “Ninth Annual Sentinel Initiative Public Workshop.” Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Topics will include an update on the state of FDA's Sentinel Initiative, including an overview of the current state of Sentinel System safety surveillance activities, and uses of the Sentinel System accomplished in 2016.
The event will be held on February 2, 2017, from 9 a.m. to 4:30 p.m. EST at the Barbara Jordan Conference Center at the Kaiser Family Foundation, 1330 G St. NW., Washington, DC 20005. For additional travel and hotel information, please refer to https://healthpolicy.duke.
Patient-Focused Drug Development for Sarcopenia - April 6, 2017
On April 6, 2017, FDA is conducting a public meeting on Patient-Focused Drug Development for sarcopenia, loss of muscle mass and loss of muscle function or strength that occurs with age. The purpose of the meeting is to gather patients’ perspectives on symptoms and daily impacts that matter most to them, and to discuss current treatment options. This meeting is an exciting opportunity for patients to bring their voice to FDA and the drug development process. Learn more and register to attend the meeting in-person or via webcast by visiting https://sarcopeniapfdd.
Patient-Focused Drug Development for autism - May 4, 2017
On May 4, 2017, FDA is conducting a public meeting on Patient-Focused Drug Development for autism. The purpose of the meeting is to gather patients’ perspectives on symptoms and daily impacts that matter most to them, and to discuss current treatment options. This meeting is an exciting opportunity for patients to bring their voice to FDA and the drug development process. Learn more and register to attend the meeting in-person or via webcast by visiting https://autismpfdd.eventbrite.
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