Guidelines for quality assurance in multicenter trials: a position paper

Area of Science:

• Clinical Trials Methodology
• Data Integrity in Research
• Multicenter Study Design

Background:

• Concerns regarding data falsification in a National Surgical Adjuvant Project for Breast and Bowel Cancer trial led to public, press, and congressional scrutiny.
• Questions arose about the quality, integrity, analysis, and conclusions of clinical trial data.
• This scrutiny prompted a need for enhanced standards in clinical trial data management.

Purpose of the Study:

• To address issues of data integrity and auditing in clinical trials.
• To establish comprehensive guidelines for quality assurance in multicenter clinical trials.
• To recommend actions for addressing data quality problems.

Main Methods:

• Formation of a subcommittee by the Society for Clinical Trials leaders in 1995.
• Subcommittee members consulted on data cleanliness, auditing requirements, and audit procedures.
• Development of guidelines for quality assurance standards based on subcommittee discussions.

Main Results:

• Initial discussions revealed that data auditing alone is insufficient for ensuring data integrity.
• The subcommittee concluded that a broader approach to quality assurance is necessary.
• Guidelines were prepared to set standards for quality assurance in multicenter clinical trials.

Conclusions:

• Data auditing is not sufficient to guarantee data integrity in clinical trials.
• Comprehensive quality assurance standards are essential for multicenter clinical trials.
• Guidelines are provided to enhance data integrity and outline actions for detected problems.