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ANCILLARY STUDIES...




BUDGETARY ASPECTS OF THE PROPOSAL:
Investigators who are interested in proposing an ancillary study and need further clarifications about budgetary or other aspects of their proposal are encouraged to contact the Chairperson of the ASC (Dr. Fava) who will provide them with written instructions outlining the general principles of ancillary studies and asking the investigators to address the issue of the projected burden on patients and investigators within their application, including a budget for expenses related to the implementation of their ancillary study and to offset the procedural burden. Some examples are provided below, using the following projected costs: a $25 consent form fee and a $25 procedure fee per patient (for either a blood draw or the administration of questionnaires) to offset the burden on staff at the different venues, a $25 study participation fee to offset the burden on subjects, 15% effort of each Regional Center director at an average investigator salary (including fringe benefits) of $150,000, and 25% effort of a research assistant at each Regional Center to coordinate and facilitate the implementation of the added procedures, at an average salary (including fringe benefits) of $49,000.
  • One type of ancillary study proposal may involve all the Regional Centers. For example, an ancillary proposal on pharmacogenomics might propose to conduct a single blood draw for 2000 patients at all 12 Regional Centers. Using the projected costs mentioned above, this application should therefore include in the budget 1.8 FTEs for Regional Center directors, 3 FTEs for research assistants at the Regional Center level, and $150,000 for direct procedural costs ($100,000 for the consent form and procedure fees at the different venues and $50,000 for the participation fees). If subjects would be enrolled into STAR*D over three years and the fees were evenly distributed over these years, the yearly direct cost to offset the procedural burden for such a proposal would be $467,000, divided into the 14 Regional Centers. As the complexity and the time commitment of the procedures involved in the proposed study increases (and the procedures of the STAR*D protocol and of the approved and up and running ancillary studies will be made available through the STAR*D web page), the proposing investigator should factor those considerations into the budget plus the NIMH indirect rates for the 14 Regional Centers.


  • A second type of proposal may involve an ancillary study carried out only at some (but not all) Regional Centers. Whenever possible, applications for NIMH funding of such proposals should utilize the collaborative R-01 grant mechanism. For example, an ancillary study proposal on pharmacogenomics might propose to conduct a single blood draw for 660 patients at four Regional Centers. This application should therefore include in the budget 0.6 FTE for Regional Center investigators, 1 FTE for research coordinators at the Regional Center level, and $49,500 for direct procedural costs ($33,000 for the consent form and procedure fees at the different venues and $16,500 for the participation fees). If subjects would be enrolled into STAR*D over three years and the fees were evenly distributed over these years, the yearly direct cost to offset the procedural burden for this proposal would be $156,500, divided into the 4 Regional Centers.


  • A third type of proposal may involve an ancillary study to be carried out only at a single Regional Center. Even if submitted by one of the Regional Center investigators, this type of proposal is also required to provide a specific budget to offset the procedural burden as it is in the Regional Center's best interests to ensure that the ancillary study facilitates and does not impede subject recruitment and retention. In addition, such a proposal should include a letter of support from the Regional Center Director supporting the added initiative and providing reassurance that the procedural burden has been dealt with appropriately, and it also must appraise the likely effect on enrollment and participation of subjects in the STAR*D protocol. The proposing investigator should contact the Regional Center Director with the prior knowledge and approval of the ASC and the STAR*D EC.
Another aspect of the budget should involve data management and analysis. Proposing investigators are encouraged to contact Dr. Steve Wisniewski or his designee about a collaboration with the University of Pittsburgh Epidemiology Data Center.

Ancillary Studies Data Management and Analysis

The data management activities for all STAR*D ancillary studies will be carried out by the STAR*D Data Coordinating Center (DCC). Therefore, any STAR*D ancillary study application will be required to support the necessary personnel at the STAR*D DCC.

The STAR*D DCC will work with investigators submitting ancillary studies to devise the best approach to collecting and managing the data. STAR*D will be using a number of data entry techniques that can be used in ancillary studies which will be available to investigators. This includes direct data entry during telephone interview, scanning, and integrated voice recognition (IVR) entry over the telephone. In addition, other data collection and entry solutions are available.

Investigators for ancillary studies are encouraged, although not required, to have the statistical analyses conducted by the STAR*D DCC. If this approach is taken, then the necessary support will need to be included in the budget for statistical personnel. Whether or not the DCC is to carry out the data analyses, all final analyses will need to be reviewed Drs. Lavori and Wisniewski. This will include the shipment of all source code, documentation, and data set for review.

In the case of an ancillary study aimed at seeking support from a pharmaceutical company, the budget for the ancillary study should be reviewed by the ASC before the proposal is submitted for funding.