Cancer Chemotherapy and Pharmacology

, Volume 42, Supplement 1, pp S88–S92 | Cite as

Systems of protocol review, quality assurance, and data audit

  • Raymond B. Weiss
Original Article

Abstract

The US National Cancer Institute (NCI) is the world’s largest sponsor of clinical trials in cancer treatment and biology, and it is responsible for the reliability of data generated by means of its funding. The cooperative groups supported by the NCI consist of main academic institutions and smaller affiliates of these institutions. The size of these groups, their geographical dispersion, and the number of studies accruing patients at any one time make it a challenge to ensure that all requirements of institutional oversight, patient consent, protocol compliance, and data submission and quality are met. Each cooperative group has established various procedures for quality assurance. These include data coordinators at the data management center of the group, study chairs, and statisticians. In addition, each group has a committee of physician-investigators and clinical research associates who make periodic site visits to all member institutions to audit the on-site medical records of a sample of patients entered at that institution. The study records are compared with the medical records for all aspects of protocol management and data generation. In addition, adherence to requirements for consent-form signing and oversight by an institutional review board is assessed. Deviations from the study requirements are evaluated as being minor or major. A written report of the audit result is provided to both the NCI and the relevant administrative components of the cooperative group. The audit process has uncovered rare instances of scientific improprieties in these NCI-funded clinical trials, but more importantly it has educated investigators and support staff to improve adherence to research and data-collection requirements, which has resulted in greater reliability of study results.

Key words

US National Cancer Institute Cooperative groups Quality assurance Cancer treatment 

References

  1. 1.
    Anonymous (1994) What’s behind the NSABP clash? Ann Oncol 5:481Google Scholar
  2. 2.
    Canellos GP, Anderson JR, Propert KJ, Nissen N, Cooper MR, Henderson ES, Green MR, Gottlieb A, Peterson BA (1992) Chemotherapy of advanced Hodgkin’s disease with MOPP, ABVD, or MOPP alternating with ABVD. N Engl J Med 327:1478PubMedGoogle Scholar
  3. 3.
    Cheung N-KV, Lazarus H, Miraldi FD, Berger NA, Abramowsky CR, Saarinen UM, Spitzer T, Strandjord SE, Coccia PF (1992) Reassessment of patient response to monoclonal antibody 3F8. J Clin Oncol 10:671PubMedGoogle Scholar
  4. 4.
    Christian MC, McCabe MS, Korn EL, Abrams JS, Kaplan RS, Friedman MA (1995) The National Cancer Institute audit of the National Surgical Adjuvant Breast and Bowel Project protocol B-06. N Engl J Med 333:1469PubMedCrossRefGoogle Scholar
  5. 5.
    Dingell JD (1993) Shattuck lecture-Misconduct in medical research. N Engl J Med 328:1610PubMedCrossRefGoogle Scholar
  6. 6.
    Federal Register (11 June, 1982) 47:25413Google Scholar
  7. 7.
    Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, Omura GA, Moore JO, Mclntyre OR, Frei M for the Cancer and Leukemia Group B (1994) Intensive postremission chemotherapy in adults with acute myeloid leukemia. N Engl J Med 331:896PubMedCrossRefGoogle Scholar
  8. 8.
    Steward WP, Vantongelen K, Verweij J, Thomas D, van Osteroom AT (1993) Chemotherapy administration and data collection in an EORTC collaborative group-can we trust the results? Eur J Cancer 29A:943PubMedCrossRefGoogle Scholar
  9. 9.
    Weiss RB, Vogelzang NJ, Peterson BA, Panasci LC, Carpenter JC, Gavigan M, Sartell K, Frei E, Mclntyre OR (1993) A successful system of scientific data audits for clinical trials. A report from the Cancer and Leukemia Group B. JAMA 270:459PubMedCrossRefGoogle Scholar
  10. 10.
    Wood WC, Budman DR, Korzun AH, Cooper MR, Younger J, Hart RD, Moore A, Eilerton JA, Norton L, Ferree CR, Ballow AC, Frei E, Henderson IC (1994) Dose and dose intensity of adjuvant chemotherapy for stage II, node-positive breast carcinoma. N Engl J Med 330:1253PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag 1998

Authors and Affiliations

  • Raymond B. Weiss
    • 1
  1. 1.Lombardi Cancer CenterGeorgetown University School of Medicine, Washington, DC and the Cancer and Leukemia Group BChicagoUSA

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