Minimally Disruptive Research: A Respectful Approach to Conducting Clinical Studies
Sara Dick, MS, CCRP, Research Protocol Specialist, Mayo Clinic
The design and conduct of clinical studies must achieve the research goals while minimizing the work allocated to participants (clinicians and patients). Research must impose the smallest positive footprint on clinical care activities. We have come to call this, Minimally Disruptive Research. Our adherence to this new standard requires participants (both patients and clinicians) as research partners to engage with investigators at every step of the research process to ensure that all procedures result in CAREFUL and KIND Research.
The Importance of the Clinical Research Enterprise in Assuring its Quality and Success
Dr. Robert O'Neill, PhD, Senior Statistical Advisor, FDA
Virtually every clinical study of a medical product that reaches Phase II or Phase III can have commercial implications and will be subject to regulatory oversight (e.g. IND or IDE), and eventually regulatory review if submitted to support market approval and health claims. Dr. O'Neill will discuss important aspects of study planning, conduct, analysis, reporting, quality assurance, monitoring, staff training and competencies relevant to the clinical research enterprise. The perspective will be that of the regulatory scientific review of evidence to support claims and the components of that process.
Recent Advances in the Early Detection of Alzheimer's Disease
Dorene Rentz, PsyD, Co-Dir, Center for Alzheimer's Research & Treatment, Brigham & Women's Hospital
With the advent of in vivo amyloid and tau imaging, we know that 30% of all cognitively normal older adults harbor significant pathological burden consistent with the diagnosis of Alzheimer’s disease (AD). Identified as preclinical AD, these underlying pathophysiological changes are occurring 15-20 years in advance of clinical symptoms. Dr. Rentz will discuss the theoretical concept of preclinical AD, the recent understanding of cognitive changes associated with biomarker evidence of preclinical AD, and current prevention strategies and treatment trials that are being implemented in the field.