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ANCILLARY STUDIES...




STAR*D MULTI-CENTER ANCILLARY STUDY POLICY CONCERNING REGIONAL CENTER SELECTION:
The guiding principles of the STAR*D policy concerning Regional Center selection of for participation in ancillary studies are the following:
  • 1) "Level of Interest" - Regional Center Directors need to notify the Chair of the Ancillary Study Committee (Dr. Fava) of their interest in participation in the ancillary studies available. Dr. Fava will ensure that Regional Center Directors will be informed of any ancillary study approved by the STAR*D and subsequently funded.

  • 2) "Fair Distribution of Wealth": - the STAR*D EC Committee will make a specific effort to reward all Regional Centers for their participation in STAR*D by ensuring that all interested regional Centers have the opportunity to participate in ancillary studies. The STAR*D EC Committee will also attempt to distribute equally and fairly such participation, while considering all other guiding principles.

  • 3) "Hands-on Experience" - The Coordinating Center of the funded ancillary study will always be one of the regional centers for that particular study to ensure that the principal investigators for the ancillary study itself will have hands-on experience with the protocol that they are running and to further increase the motivation to enroll patients into the main protocol of STAR*D. In addition, this will ensure that the efforts to obtain funding for such ancillary study proposal will be rewarded.

  • 4) Pertinent Experience - The STAR*D EC Committee will make a specific effort to ensure that, whenever possible, the Regional Centers with prior pertinent experience in the area of research of the ancillary study would participate in such study, if they show interest.

  • 5) Performance in the STAR*D Protocol - Once the study is up and running, the STAR*D EC Committee will make a specific effort to ensure that, whenever possible, the Regional Centers with the best performance (in terms of enrollment and relative lack of protocol violations) in the main STAR*D protocol would participate in the ancillary study, if they show interest.

  • 6) Participation and performance of each Regional center in both STAR*D and its ancillary studies is reviewed by the STAR*D EC Committee every 6 months; if the performance of a particular Regional Center in STAR*D is considered poor and the ancillary study is considered a further obstacle to enrollment, the STAR*D EC Committee has the right to replace such Regional Center with another Center that is performing well in STAR*D and is interested in participating.

  • 7) The Regional Centers will respond to the enclosed questionnaire whenever a new ancillary study becomes available; their responses will be preliminarily ranked by the Ancillary Study Committee (chaired by Drs. Fava and Rush) and then reviewed by the STAR*D EC Committee, which will establish the final ranking. Such ranking will be used for the Regional Center Selection.