title: A quality assurance audit: phase III trial of maximal androgen deprivation in prostate cancer (TROG 96.01).
abstract: In 1997 the Trans-Tasman Radiation Oncology Group (TROG) performed a quality assurance (QA) audit of its phase III randomized clinical trial investigating the effectiveness of different durations of maximal androgen deprivation prior to and during definitive radiation therapy for locally advanced carcinoma of the prostate (TROG 96.01). The audit reviewed a total of 60 cases from 15 centres across Australia and New Zealand. In addition to verification of technical adherence to the protocol, the audit also incorporated a survey of centre planning techniques and a QA time/cost analysis. The present report builds on TROG's first technical audit conducted in 1996 for the phase III accelerated head and neck trial (TROG 91.01) and highlights the significant progress TROG has made in the interim period. The audit provides a strong validation of the results of the 96.01 trial, as well as valuable budgeting and treatment planning information for future trials. Overall improvements were detected in data quality and quantity, and in protocol compliance, with a reduction in the rate of unacceptable protocol violations from 10 to 4%. Audit design, staff education and increased data management resources were identified as the main contributing factors to these improvements. In addition, a budget estimate of $100 per patient has been proposed for conducting similar technical audits. The next major QA project to be undertaken by TROG during the period 1998-1999 is an intercentre dosimetry study. Trial funding and staff education have been targeted as the key major issues essential to the continued success and expansion of TROG's QA programme.
authors.affiliation: Department of Radiation Oncology, Newcastle Mater Misericordiae Hospital, Waratah, Westmead, New South Wales. mdjwd1@cc.newcastle.edu.au
authors.forename: A
authors.initials: A
authors.lastname: Steigler
authors.forename: H
authors.initials: H
authors.lastname: Mameghan
authors.forename: D
authors.initials: D
authors.lastname: Lamb
authors.forename: D
authors.initials: D
authors.lastname: Joseph
authors.forename: J
authors.initials: J
authors.lastname: Matthews
authors.forename: I
authors.initials: I
authors.lastname: Franklin
authors.forename: S
authors.initials: S
authors.lastname: Turner
authors.forename: N
authors.initials: N
authors.lastname: Spry
authors.forename: M
authors.initials: M
authors.lastname: Poulsen
authors.forename: J
authors.initials: J
authors.lastname: North
authors.forename: O
authors.initials: O
authors.lastname: Kovacev
authors.forename: J
authors.initials: J
authors.lastname: Denham
mesh_terms: D000726:Androgen Antagonists / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D003365:Costs and Cost Analysis; D005485:Flutamide / Q000627:therapeutic use*; D017273:Goserelin / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008485:Medical Audit / Q000191:economics; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D011785:Quality Assurance, Health Care; D018714:Radiotherapy, Adjuvant; D013997:Time Factors
chemical_list: D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D017273:Goserelin; D005485:Flutamide