Statistical Analysis & Reporting

Statistical Analysis & Reporting

There is no cookie cutter approach to statistical analysis for clinical trials – analytical designs are as diverse as the trials’ experimental designs. ARA understands that pulling together the specifications of the statistical analyses is a collaborative effort with the sponsor to understand the study objectives and how we can best support those objectives.

Digging into the Protocol

In working with sponsors, we first give careful consideration to the objectives of the protocol to determine how the objectives can be statistically supported. We brainstorm with the clinical team to project all the possible outcomes and then craft the  analytical specifications into the Statistical Analysis Plan (SAP).

Getting down to Specifics in the SAP

While the protocol is the controlling document for the analysis and broadly states the objectives of the study, the SAP specifies the types of statistical analysis that will be conducted on the various sub-populations, treatment groups, clinical indications, etc.

We also conduct research into past studies to examine the types of analyses and outcomes. In this way, we are able to build into your design plan outcomes that are more likely to be accepted by the FDA.

Exploratory Analysis

We also work with the researchers to ensure that we include any exploratory analysis in the SAP; for example, analyzing a subset of the population for a certain indication. Although exploratory analysis will not have the power to support the objectives of the study, the analysis can be hypothesis-generating and provide researchers some color on a hunch that they have and may inform future studies.