Upon completion of a study, the investigators analyze the results and prepare a study report that includes data and conclusions. ICH also provides guidance on the preparation of study reports.(PDF - 471 KB)
The researcher analyzes the data "in aggregate," meaning the data are combined so that no one can determine whose data are whose. The analysis proceeds according to the statistical and analytic plan outlined in the study protocol. There are multiple acceptable approaches to analyzing data. Generally, goals of the study and the question being asked guide the selection of the type of analysis. In addition to the primary analysis that is defined in the protocol statistical analytic plan in advance, there can be exploratory, or secondary analyses that are developed after the study is completed with each involving a different type of approach. The primary analysis is what is used to reach any conclusions and the exploratory analyses are used to generate new ideas or hypotheses for planning future studies.
Clinical research results must be interpreted in context. The results of other studies, the conclusions from meta-analyses, and examinations of possible alternative explanations for the results are all considered to place the results in context of the medical and public health application.
For study results to be interpretable, they must minimize bias and minimize uncertainty. Factors that can contribute to increased bias or uncertainty include:
- Incomplete data
- Terminology that is not appropriately defined
- High number of participants who leave the study before completion
- Not performing specified analyses
- Ambiguity in measurements
- Combining data in ways not specified in the statistical analytic plan
Resources for analyzing the data and interpreting the results
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