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Related Experiment Videos

The Mid-Atlantic Oncology Program's comparison of two data collection methods.

D M Jasperse1, S W Ahmed

  • 1EMMES Corporation, Potomac, MD 20854.

Controlled Clinical Trials
|September 1, 1989
PubMed
Summary

Circuit riding data managers (CDMs) offer a viable alternative to local data managers (LDMs) in cancer clinical trials. CDMs collected data more accurately, especially regarding toxicity, compared to LDMs.

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Area of Science:

  • Oncology
  • Clinical Trials Data Management
  • Health Services Research

Background:

  • The standard method for cancer clinical trials data capture relies on local data managers (LDMs).
  • The Mid-Atlantic Oncology Program (MAOP) explored an alternative approach using circuit riding data managers (CDMs).

Purpose of the Study:

  • To compare the accuracy and reliability of clinical trial data collected by CDMs versus LDMs.
  • To assess the consistency of data coding for patient toxicity and treatment outcomes.

Main Methods:

  • Identical study forms were completed by both LDMs and CDMs for randomly selected patients on MAOP protocols.
  • Data discrepancies were resolved by a blinded principal investigator (PI).
  • A total of 1023 pairs of codes were compared, with 129 (13%) discrepancies identified.

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Main Results:

  • The PI's resolutions more frequently matched data collected by CDMs (66%) than LDMs (34%), a statistically significant difference (chi 2 = 9.61, p < 0.005).
  • CDMs consistently coded toxicities as more severe than LDMs and were found to be more accurate.
  • Discrepancies were noted in 13% of compared data points.

Conclusions:

  • Circuit riding data managers (CDMs) are a reliable alternative to local data managers (LDMs) for cancer clinical trials.
  • CDM data collection may improve the accuracy of toxicity reporting in oncology research.
  • This model is particularly suitable for regional oncology programs.