Ancillary Studies to Large Clinical Projects Group leaders and participants -Dr. Joan McGowan Director, Division of Musculoskeletal Diseases, NIAMS -Dr.

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Presentation transcript:

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

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

Points of Consideration Review 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 NHLBI Ancillary Studies to Clinical Trials (R01), RFA-HL 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

Points of Consideration Guidance 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