Identification errors in medical research: Privacy at all costs?

Area of Science:

• Laboratory Medicine
• Clinical Research Quality Assurance

Background:

• Misidentified patient samples in laboratory medicine can cause severe adverse events, including incorrect diagnoses and transfusion errors.
• While patient sample misidentification is known in routine care, its impact in clinical research is less understood but potentially more widespread.
• Data clarification forms (DCFs) are issued for discrepancies in clinical trial data, with higher rates sometimes indicating poorer trial quality.

Purpose of the Study:

• To investigate the rate and impact of patient sample misidentification in a clinical research setting.
• To assess the proportion of data clarification forms (DCFs) related to sample identification errors in clinical trials.
• To propose strategies for mitigating misidentification errors in clinical research.

Main Methods:

• Analysis of data from five clinical trials involving 822 histology or blood specimens.
• Review of data clarification forms (DCFs) issued for specimen discrepancies.
• Categorization of DCFs to identify those related to sample identification errors.

Main Results:

• DCFs were issued for 21% (174/822) of specimens across the five clinical trials.
• A significant majority of these DCFs, 67% (117/174), were attributed to sample identification issues.
• These identification errors were detected before data compromise or adverse events occurred.

Conclusions:

• Patient sample misidentification is a prevalent issue in clinical research, with a substantial percentage of errors linked to identification.
• Current practices for patient identifiers in research lack stringency, necessitating improvements.
• Implementing de-identified data points and formalised specimen accession processes, similar to routine care, can reduce misidentification errors in clinical research.