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Ancillary Studies to Large Clinical Projects

Ancillary Studies to Large Clinical Projects. Group leaders and participants. - Dr. Joan McGowan Director, Division of Musculoskeletal Diseases, NIAMS - Dr. Yan Wang Program Director, Division of Skin and Rheumatic Diseases, NIAMS - Dr. Jonelle Drugan

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Ancillary Studies to Large Clinical Projects

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  1. Ancillary Studies to Large Clinical Projects • Group leaders and participants - Dr. Joan McGowan • Director, Division of Musculoskeletal Diseases, NIAMS - Dr. Yan Wang • Program Director, Division of Skin and Rheumatic Diseases, NIAMS - Dr. Jonelle Drugan • Science Policy Analyst, Office of Science Policy and Planning, NIAMS - Ms. Barbara Footer • Research Program Analyst, Division of Skin and Rheumatic Diseases, NIAMS - Ms. Shahnaz Khan • Clinical Coordinator, Division of Extramural Research Activities, NIAMS - Ms. Anna Nicholson • Clinical Coordinator, Division of Extramural Research Activities, NIAMS - Dr. Chuck Washabaugh • Scientific Review Officer, Division of Extramural Research Activities, NIAMS 2008 NIAMS Scientific Retreat

  2. Ancillary Studies to Large Clinical Projects • Overarching question - Should NIAMS consider any new policies or mechanisms to enhance or facilitate the use of ancillary studies in its mission areas? • Key discussion points - Review considerations—will vary with proposed study - Guidance for investigators designing ancillary studies 2008 NIAMS Scientific Retreat

  3. Points of ConsiderationReview • Standard Center for Scientific Review (CSR) process - ~9 months (or more) between application submission and funding - Incompatible for ancillary studies that must start concurrently with the parent study • Expedited review to encourage ancillary studies - NIAID Hyperaccelerated Award/Mechanisms in Immunomodulation Trials (R01), RFA-AI-05-028 - NHLBI Ancillary Studies to Clinical Trials (R01), RFA-HL-07-009 • Applications that are not as time-sensitive could be reviewed through the standard CSR system - Post hoc studies - Studies that do not require additional baseline measurements 2008 NIAMS Scientific Retreat

  4. Points of ConsiderationGuidance for Investigators • Issues to be negotiated with parent study before starting an ancillary study - Data access and processing - Sample storage and sharing - Publication and authorship - Payment to parent studies for staff time and data collection • Recruitment - Participation has to be voluntary, requiring additional consent - Might not recruit the desired subset of patients • Before applying for funding (even under existing mechanisms), investigators also should obtain - Written agreements from parent trial sponsors and investigators - Approval from the IRB, steering committee, and DSMB 2008 NIAMS Scientific Retreat

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