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Longitudinal studies, sequential design, and grant renewals: what to do with preliminary data.

Longitudinal studies, protocols involving sequential design, and grant renewals all involve generating and evaluating preliminary research data. Longitudinal studies are designed to follow subjects over a specified period, for example, three years. In studies involving sequential design, the investigators observe the data as they become available, and make a decision to end the trial at the precise point where the accumulating results become statistically significant. Grant renewals provide for the continuation of protocols along previously specified lines. These types of studies pose serious ethical problems for IRB review. It is good scientific procedure and essential to the protection of human subjects to examine preliminary data to make sure that subjects are not being exposed to serious or unnecessary risks and that time and other resources are not being squandered. However, the addition of a new piece of information changes slightly the estimates of risks and benefits. In a controlled clinical