Investigating centre effects in a multi-centre clinical trial of superficial bladder cancer

✍ Scribed by Takuhiro Yamaguchi; Yasuo Ohashi

• Publisher: John Wiley and Sons
• Year: 1999
• Tongue: English
• Weight: 112 KB
• Volume: 18
• Category: Article
• ISSN: 0277-6715
• DOI: 10.1002/(sici)1097-0258(19990815)18:15<1961::aid-sim170>3.0.co;2-3

✦ Synopsis

This paper examines the amount of variation among centres and estimates the overall e!ect of therapy in a multi-centre cancer clinical trial with censored failure time data. To investigate the centre e!ects, the variation in the treatment e!ect must be taken into consideration in addition to the variation in the baseline risk. We treat centre e!ects as random ones and extend the penalized partial likelihood approach proposed by McGilchrist to estimate the treatment-by-centre interaction as well as the baseline risk. This method is applied to data from a super"cial bladder cancer clinical trial investigating the e$cacy of intravesical chemotherapy after transurethral resection. In this trial, although there exists some degree of centre variation, especially in the baseline risk, the treatment is e!ective in preventing recurrence among the participating centres. This result indicates that the treatment e!ect is generalizable to the target population.