Primary Recommendations

Build quality into the scientific and operational design and conduct of clinical trials

Focus on what matters most

• “Quality” is defined as the absence of errors that matter (i.e., errors that have
  a meaningful impact on patient safety or interpretation of results)
• Determine what matters for a specific trial

Develop a quality management plan

• Initiate plan in parallel with protocol development
• Focus on areas of highest risk for generating errors that matter
• Seek regulatory review of plan

Assess performance in important parameters

• Prospectively measure error rates of important parameters
• Tailor monitoring approach (e.g., site visits, central, statistical) to the trial
  design and key quality objectives

Improve training and procedures

• Based on measured parameters

Report findings of quality management approach

• Include issues found, actions taken, impact on analysis and interpretation of
  results
• Incorporate into regulatory submissions and publications
• Encourage inclusion in International Committee of Medical Journal Editors
  requirements

Ancillary Recommendations

Share knowledge and experience

• Collaborate among academia, industry, and regulators to share
  methodologies and data

Encourage appropriate regulatory guidance

• Emphasize key principles of quality trials (i.e., human subjects protection,
  reliable results, protocol adherence)
• Encourage risk-focused oversight of trials

Promote education and awareness

• Focus on those involved in design, implementation, analysis,
  interpretation, regulation, inspection, and publication of clinical trials
• Include users of results (e.g., health care providers, doctors, patients)

Seek international adoption and harmonization

• Facilitate global adoption of proposed changes

References

Landray MJ, Grandinetti C, Kramer JM, et al. Clinical Trials: Rethinking How We
Ensure Quality. Drug Information Journal November 2012; 46:657-660.

Morrison BW, Cochran CJ, White JG, et al. Monitoring the quality of conduct of
clinical trials: a survey of current practices. Clinical Trials June 2011; 8(3):342-9.