Data and monitoring

Another practical issue concerns the amount and type of data collected. In an early trial, it may be necessary to collect detailed data on compliance and toxicity. Even if the ultimate aim is to improve survival through the use of a new treatment, it may be important to collect data on intermediate outcome measures such as recurrence or progression. As the public health trial will generally be larger, it should be designed to make participation as easy as possible and onerous data collection is known to be a major deterrent. Investigations which are not part of normal practice should be limited or eliminated if they are not (or no longer) necessary for assessing safety and outcome. The very minimum which might be collected is basic patient identification, allocated treatment, and outcome. If the main outcome is survival, then this can, in some countries, be obtained through central population records with no need, in theory, to collect any further data. While this extreme is rarely realistic, it serves as a good starting point for deciding what data to collect.

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