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Importance of Pilot Data

It may seem ironic that pilot data are always needed to garner funding even when one is requesting funding to conduct a pilot study. The point is that some proof of concept is needed to show that the request for funds, whether for a small- or large-scale complex study, is reasonable, can be conducted in the proposed time line, and has potential to yield important outcomes. The type of pilot data required will depend upon the phase of development of the intervention. For example, even when requesting funds for manual development and protocol advancement, providing pilot data demonstrating the feasibility of the approach is necessary. This may take the form of focus groups or a needs assessment in which the outcomes demonstrate support for the significance of the proposed intervention. When requesting funds for a Phase III efficacy trial, each primary aim should be supported by pilot data that show positive outcomes and support an investment in the proposed trial. For proposed interventions that are multicomponent, it is necessary to demonstrate the feasibility of each component through pilot testing.

Pilot testing of some sort is important at every phase including translation and implementation. As discussed previously, obtaining even small funds from one’s department or university can thus be extremely helpful in building an intervention and should be sought after and utilized to pilot test different elements or protocols of an intervention. In addition, pilot data to support other elements of a proposal are important. These include but are not limited to demonstrating that the recruitment plan (see Chapter 10) is feasible and will yield the targeted sample size (see Chapter 9), and that the interview battery does not cause undo participant burden. Also important are data supporting the projected attrition rate, the adequacy of measures, and approaches to data capturing.

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