Good Statistical Practice-development of tailored Good Clinical Practice training for statisticians

Area of Science:

• Clinical Research Methodology
• Statistical Integrity in Trials
• Regulatory Compliance in Healthcare

Background:

• Current Good Clinical Practice (GCP) training is generic and lacks statistical relevance for research professionals.
• Statisticians require role-specific training to effectively implement regulatory requirements in clinical trials.
• Existing training variations impact the quality, transparency, and reproducibility of statistical conduct in research.

Approach:

• The Good Statistical Practice (GCP for Statisticians) project developed tailored training materials based on MHRA GCP guidelines.
• A survey confirmed the need for dedicated GCP training for statisticians in clinical research.
• Training materials were critically reviewed and piloted with clinical trial unit (CTU) researchers and regulatory bodies.

Key Points:

• A comprehensive, accessible, and piloted training package was created specifically for statisticians.
• Materials cover legislation and best practices for statistical activities throughout clinical trial processes.
• Exercises and real-life scenarios bridge the gap between theoretical knowledge and practical application.

Conclusions:

• Role-specific GCP training is essential for statisticians to ensure transparent and reproducible statistical activities.
• The developed training materials are freely available for adoption nationally and internationally.
• Implementing this training promotes adherence to regulatory standards and enhances overall clinical research quality.