This post is sponsored by DIA.
As Alzheimer’s research evolves, two things remain consistent—the challenges associated with subject recruitment and the critical role caregivers play in the process. With an estimated 5.3 million Americans living with Alzheimer’s disease in 2015, the need for research—and research subjects—is greater than ever.
Recruiting for Alzheimer’s registries comes with many inherent challenges: the varying degree of symptoms from individual to individual, privacy uncertainties and complications, and the need to involve both the individual and the caregiver in the process. When building registries to support Alzheimer’s clinical trials, “caregivers, or ‘study partners,’ are absolutely critical,” says Craig A. Metz, PhD, Senior Vice President, Zinfandel Pharmaceuticals, Inc. “Often, the partner may notice emerging issues before the person developing the disease. We absolutely need to enroll partners in these registries.”
Dr. Metz will chair an upcoming panel discussion at the DIA 2015 51st Annual Meeting on this topic. “Using Registries to Support Recruitment in Alzheimer’s Disease (AD) Prevention or Delay-of-Onset Studies” will focus on the challenges of building and using registries to recruit subjects for trials on delay-of-onset of mild cognitive impairment due to Alzheimer’s disease. Tactics and tools for registry recruitment and access, as well as methods for ensuring Health Insurance Portability and Accountability Act (HIPAA) and regulatory compliance, also will be addressed. Data evaluating the potential impact of registries on recruitment in an ongoing clinical trial will be presented.
Panelists will include Kathleen Anne Welsh-Bohmer, PhD, Professor, Duke University; Rachel L. Nosheny, PhD, Research Scientist, Center for Imaging of Neurodegenerative Diseases, San Francisco VA Medical Center; Joshua Grill, PhD, Department of Psychiatry & Human Behavior, Institute for Memory & Neurological Disorders, University of California, Irvine.
“It’s a new day in Alzheimer’s research,” said Dr. Metz. “Through previous clinical trials, we’ve learned that therapeutic intervention once the disease is established may not be effective. Ongoing development of innovative disease biomarkers and identification of potential risk factors have fostered a new paradigm for Alzheimer’s disease research focused on treating individuals prior to the emergence of significant clinical symptomatology or evidence of cognitive decline. Public awareness of the disease is greater than ever, and the availability of novel investigational therapies holds great promise for a therapeutic breakthrough. What is needed now are new recruiting tools for the large, long-term clinical trials required to bring this promise to fruition.” Registries may form an important component of this toolkit.
Join Dr. Metz and the panelists to discuss these issues and more at the upcoming panel, “Using Registries to Support Recruitment in Alzheimer’s Disease (AD) Prevention or Delay-of-Onset Studies,” taking place June 16, 10:30 am – 12:00 pm ET at the DIA 2015 51st Annual Meeting.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The meeting brings together a global network of life sciences professionals to foster innovation that will lead to the development of safe and effective medical products and therapies. This year’s event offers more than 245 educational offerings throughout 20 tracks, 450+ exhibiting companies, and more than 125 representatives from global regulatory agencies. The meeting provides participants with a valuable opportunity to network with professionals from around the world, share knowledge, and build new relationships.
Register for DIA’s 2015 51st Annual Meeting and join the conversation on Twitter @DrugInfoAssn using #DIA2015.
