CANCER CLINICAL TRIALS WORKING GROUP

Meeting notes:
October 17, 2005:  Sequential monitoring of clinical trials using likelihood methods (Jeff Blume's slides 2000, slides 2005)
October 24, 2005:   Use of support in DSMBs (Jay Herson's notes)
October 31, 2005:    Simulation results with survival endpoint (Amanda Blackford's slides, R code)
November 7, 2005:   More simulation results with survival endpoint (Amanda Blackford's slides, R code)
November 14, 2005:   Yet more simulation results with survival endpoint (Amanda Blackford's slides, R code)
November 21, 2005:   Robustness of likelihood inference to violations of model (Liz G-M's slides, R code ( functions, commands) )
November 28 2005:   Two-stage design methods for continuous outcomes (Steve Piantadosi presented.  slides TBA )
December 5, 2005:  Randomized Discontinuation Designs (Zhe's slides,  link to article)
December 12, 2005:  cancelled due to conflicts
December 19, 2005:  cancelled due to oncology biostats Christmas party
December 26, 2005:  cancelled due to Christmas holiday
January 2, 2006:  cancelled due to New Year's holiday
January 9, 2006:  Robustifying likelihoods in the context of time-to-event outcomes (Liz's slides, Royall and Tsou article)
January 16, 2006:  cancelled due to MLK Jr holiday
January 23, 2006:  More on robustifying likelihoods:  see slides from Jan 27.
January 30, 2006:  More on robustifying likelihoods (liz's slides)
February 6, 2006:  Two stage design with multiple outcomes of interest (Amanda's slides, article)
February 13, 2006:   Results from WHI study:  low-fat diet association with cancer risk (Xiaobu's slides, article)
February 20, 2006:  cancelled due to illness of presenter
February 27, 2006:  Statistical issues with the WHI (Prentice et al. Biometrics article, Elizabeth Sugar's slides)
March 6, 2006:  Bayesian designs for monitoring TTE outcomes (Thall et al. Clinical Trials article, Liz G-M's slides)
March 13, 2006:  no agenda--catch up on current projects
March 20, 2006:  Two-treatment simultaneous dose escalation (Elizabeth Sugar's slides)
March 27, 2006:   Meta-analysis of prostate cancer survival curves based on limited information (Amanda Blackford)
April 3, 2006:  Introduction to the EAST software (Jay's slides)
April 10, 2006:  Statistical and design issues in biomarker studies (pdf by Baker et al., Liz's slides)
April 17, 2006:  meeting cancelled (Easter Monday)
April 24, 2006:  informal updates
May 1, 2006:  cancelled due to conflicts
May 8, 2006:  power calculations for linear regression with multiple predictors  (Zhe's slides, paper)
May 15, 2006:  Liz's talk for SCT (slides)
May 22, 2006:  cancelled due to SCT meeting
May 26, 2006: cancelled due to Memorial Day holiday
Summer hiatus.....
July 19, 2006:  non-inferiority trials (Jay's slides, three references:  ref1, ref2, ref3)
August 2, 2006:  organizational meeting (document from Jay r.e. FDA)
August 17, 2006:  PK and PD endpoints in cancer clinical trials (Elizabeth's slides, Foster slides)
August 31, 2006:  Competing risks analysis using R (Liz's slides)
September 7, 2006:  no meeting
September 14, 2006:  no meeting
September 21, 2006:  update on early stopping in Phase II studies with TTE outcomes (liz's slides)
September 28, 2006:   Randomized Phase II studies:  when to use them versus single arm (Clinical Trials paper)
October 5, 2006:   Using TITE-CRM  trial design for Phase I studies (JCO paper, Biometrics paper)
October 12, 2006:  Ciprian Crainiceanu on "non-dominance" in a setting of mixture models with binary outcomes.
October 19, 2006:   More TITE-CRM:  Application to a trial with gemcitabine+radiation therapy in pancreatic cancer (JCO paper)
October 26, 2006:  Steve Piantadosi discusses his entropy approach to sample size calculations for proof-of-principle studies (Clinical Trials paper, slides)
November 2, 2006:  Jay Herson discusses confidence intervals for censored survival data (see references 2, 4, and 5 below, slides).
November 9, 2006:  Steve Piantadosi discusses "landmark" analyses and time-dependent covariate analyses.  (mantel and byar paper)
November 16, 2006:   No meeting (to many of us absent)
November 23, 2006:  THANKSGIVING  (give thanks for having the day off)
November 30, 2006:  Jay Herson discusses estimation of differences in Poisson rates (see references 1 and 6 below)
December 7, 2006:  Discussion of Phase I trial conduct with CRMs.  Software, options, practical issues. 
December 14, 2006:  Discussion of FDA meeting r.e. adaptive designs.  (jay's slides)
December 21, 2006:  Two-stage adaptive designs for phase II clinical trials with binomial outcome. (banerjee and tsiatis paper)


Additional Manuscripts of Interest:

1) Berry (1983) The Analysis of Mortality by the Subject-Years Method.  Biometrics, 39(1), pp. 173-184.

2) Brookmeyer and Crowley (1982) A Confidence Interval for the Median Survival Time.  Biometrics, 38(1), pp. 29-41.

3) Haybittle (1971) Repeated Assessment of Results in Clinical Trials of Cancer Treatment.  British Journal of Radiology, 44, pp. 793-797.

4) Murphy (1995)  Likelihood Ratio-Based Confidence Intervals in Survival Analysis.  JASA, 90, pp. 1399-1405.

5)  Thomas and Grunkmeier (1975) Confidence Interval Estimation of Survival Probabilities for Censored Data.  JASA, 70, pp. 865-871.

6)  Ng HK and Tang ML. Testing the equality of two Poisson means using the rate ratio. Statistics in Medicine 24: 955-965, 2005