This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Soran, A Articles by Passarello, M Search for Related Content PubMed PubMed Citation Articles by Soran, A Articles by Passarello, M Social Bookmarking                         What's this?

Centralized medical monitoring in phase III clinical trials: the National Surgical Adjuvant Breast and Bowel Project (NSABP) experience

L Nesbitt

E P Mamounas

B Lembersky

J Bryant

S Anderson

A Brown

M Passarello

NSABP Biostatistical Center, One Sterling Plaza, Suite 350, 201 N. Craig Street, Pittsburgh, PA 15213, USA

Background There is a need for data quality assurance procedures in phase III cancer trials. At the National Surgical Adjuvant Breast and Bowel Project (NSABP) ‘real-time’ systems have been developed for quality assurance and study monitoring: (1) manual review and triage of data forms by data managers at the time of submission; (2) computerized edit checking of all submitted data forms; (3) systematic review of eligibility, treatment compliance and toxicity in the first 100 patients of a new protocol; (4) prospective centralized medical review of all reported serious adverse events, treatment failures, second primary cancers and deaths; (5) quarterly review and approval of study summary data files by project statistician; and (6) on-site auditing.

Purpose To assess the utility of an additional final comprehensive review of all patient records to confirm eligibility, disease status and vital status prior to manuscript submission.

Methods Four phase III NSABP studies, which had been monitored using the triagebased quality assurance program described above, were selected for analysis (n = 7972). Charts for 5965 patients were identified that had not been previously medically reviewed for protocol events of recurrence, second primary cancer or death. Submitted source documents and data forms of these 5965 NSABP patient records underwent medical review to verify patient eligibility, disease status and vital status.

Results This final comprehensive review found no additional treatment failures or deaths, identified seven additional cases of ineligibility, was time-intensive requiring enormous use of expensive resources, and was therefore judged not to add significantly to the integrity of the database.

Limitations Our findings are influenced by the procedures the NSABP employs for quality assurance and study monitoring for Phase III clinical trials and may have limited generalizability to other settings.

Conclusion In the presence of multiple quality assurance and data monitoring systems, the rare discrepancies found between the data forms and source documentation does not support the routine use of a final comprehensive chart review for phase III trials at the NSABP Biostatistical Center.

Clinical Trials, Vol. 3, No. 5, 478-485 (2006)
DOI: 10.1177/1740774506070747


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				K. Ruddy, E. Mayer, and A. Partridge Patient adherence and persistence with oral anticancer treatment CA Cancer J Clin, January 1, 2009; 59(1): 56 - 66. [Abstract] [Full Text] [PDF]