Inclusion Across the Lifespan PDF
Preview Inclusion Across the Lifespan
Inclusion Across the Lifespan Marie A. Bernard, MD Janine A. Clayton, MD Dawn Corbett, MPH 1 Objectives of Presentation st • Review steps taken to implement requirements of 21 Century Cures regarding age of participants in clinical research • Present proposed changes to policy and procedures 2 Background 3 Timeline of NIH Inclusion Policies and Participant Data Collection 1986 1993 1998 2002 2015 2016 • NIH • PL103-43 • NIH issues • NIH requires • NIH issues • 21st Century establishes requires policy electronic notice Cures Act policy inclusion of requiring submission changing includes new encouraging women and inclusion of definition of requirements of researchers minorities in children in child from on age of aggregate- to include NIH clinical NIH clinical individuals participants level women in research research under 21 to in NIH participant studies under 18 Clinical data on Research sex/gender race and ethnicity 4 4 Requires NIH to: 1. Convene a workshop on age groupings and age exclusions in clinical research within 180 days of enactment • Post workshop findings on NIH website 2. Publish data on age of participants in NIH clinical research, including pediatric subgroups 3. NIH Director must determine whether the inclusion guidelines on age need revision within 180 days of the workshop 5 5 Actions Taken 6 Inclusion Across the Lifespan Workshop June 1-2, 2017 Bethesda, MD Purpose: To discuss the challenges and barriers to including children and older adults in clinical trials and to identify strategies that would produce more age-inclusive clinical trials. 7 7 Inclusion Across the Lifespan Working Groups • Four working groups discussed the following topics: • Study Populations • Ethical Issues • Study Design • Data Collection and Reporting • Workshop identified a number of themes applicable to NIH, government research entities, and the scientific community as a whole. • Videocast available at https://videocast.nih.gov/launch.asp?23334 8 Inclusion Across the Lifespan RFI 9 10
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