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 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-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 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