The Melanoma Genomics Managing Your Risk Study randomised controlled trial: statistical analysis plan

Area of Science:

• Genomics and personalized medicine
• Dermatology and cancer prevention
• Public health and behavioral science

Background:

• The Melanoma Genomics Managing Your Risk Study is a randomized controlled trial investigating the impact of personal genomic risk information on ultraviolet radiation (UV) exposure.
• The study stratifies participants by phenotypic risk (low or high) and aims to reduce UV exposure, with primary outcomes measured at 12 months.
• Secondary outcomes include UV exposure patterns, sun protection behaviors, and ethical considerations of population-level genomic testing.

Purpose of the Study:

• To prospectively publish the pre-determined statistical analysis plan (SAP) before database lock and the commencement of data analysis.
• To ensure transparency and minimize potential analysis bias by adhering to a pre-defined SAP.
• To outline the statistical procedures for analyzing primary, secondary, subgroup, and sensitivity analyses of the trial outcomes.

Main Methods:

• The SAP details data synthesis, analysis principles, and statistical procedures for the randomized controlled trial.
• The plan was approved after recruitment closure and before patient follow-up completion.
• Health economic outcomes will be analyzed separately; this SAP focuses on clinical and behavioral outcomes.

Main Results:

• The statistical analysis plan is consistent with best practices for transparent reporting.
• Adherence to the SAP will ensure the integrity of the trial's findings.
• The plan facilitates a rigorous evaluation of the intervention's efficacy.

Conclusions:

• The developed SAP for the Melanoma Genomics Managing Your Risk Study will guide the final data analysis.
• Following this plan is crucial for maintaining high standards of internal validity.
• The SAP aims to minimize analysis bias, ensuring reliable and trustworthy results.