Bayesian clinical trials at the University of Texas M. D. Anderson Cancer Center.
BACKGROUND
The Bayesian approach is being used increasingly in medical research. In particular, it has become a standard in designing clinical trials at the University of Texas M. D. Anderson Cancer Center.


OBJECTIVE
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METHODS
To address the extent and nature of Bayesian trials conducted at M. D. Anderson, we reviewed the protocols registered in the Protocol Document Online System between 2000 and early 2005. We summarize our findings and give details for three innovative trials that typify those in which a Bayesian approach has played a major role at the center.


RESULTS
Of 964 protocols reviewed, 59% were conducted solely at M. D. Anderson and the rest were multicenter trials. Bayesian designs and analyses were used in about 20% (195/964) of the protocols that we reviewed. Of the 520 protocols identified as phase I or II drug trials, about 34% were Bayesian. Most of the 195 Bayesian trials were designed by M. D. Anderson statisticians. The Bayesian design features most commonly used were the continuous reassessment method in phase I (toxicity) trials, adaptive randomization in phase II trials, and designs to monitor efficacy and toxicity simultaneously. We also provide an insider's view regarding some practical considerations that have made the design and implementation of so many Bayesian trials possible.


CONCLUSIONS
We reviewed only a subset of all M. D. Anderson protocols, but did not exclude any available in electronic form.


CONCLUSIONS
The large number of Bayesian trials conducted at M. D. Anderson testifies to the receptivity to the Bayesian approach within the center, including principal investigators, regulatory review committees, and patients. Statisticians who take a Bayesian perspective can successfully work to establish a culture of innovation in clinical trial design.
Biswas
Swati
S
Department of Biostatistics, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, USA.
Liu
Diane D
DD
Lee
J Jack
JJ
Berry
Donald A
DA
D000046:Academic Medical Centers; D000570:American Cancer Society; D001499:Bayes Theorem; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D013781:Texas; D014481:United States