Medical University

of South Carolina

Hollings Cancer Center at MUSC

Biostatistics Shared Resource

at Hollings Cancer Center

Division of Biostatistics & Epidemiology at  MUSC

Early Phase Clinical Trials Working Group

 

About us:  We are a group of biostatisticians at the Medical University of South Carolina who are interested in learning more about and developing methodology related to early phase clinical trials. 

Some of our applied areas of interest are cancer and neurology.

 

Current members:  Elizabeth Garrett-Mayer, Sharon Yeatts, Yuko Palesch, Dipankar Bandyopadhyay, Emily Kistner-Griffin, Hiya Banerjee, Renee Martin, Amy Wahlquist, Kent Armeson, Cody Chiuzan, Jody Ciolino, Joyce Nicholas, Angela Wu, Bethany Wolf, Betsy Hill.

 

Our meetings:  We meet the third Monday of the month from 1:15-2:30 in Room 304 of Cannon Place (135 Cannon St.).

 

Interested in joining?   Please contact us to join our email list.

 

Our calendar:

 

Date

Presenter

Topic

Links to Paper(s)

September 20, 2010

Liz Garrett-Mayer

Organizational meeting and overview

Zohar and Chevret (2007)

Suman et al. (2008)

Clinical Cancer Research volume with focus on Phase 0 trials

October 18, 2010

Amy Wahlquist

Designing Phase 0 Cancer Clinical Trials

Murgo et al (2008)

November 15, 2010

Cody Chiuzan

Outcome adaptive methods in dose-finding trials

Whelan et al. (2008);   Thall, Cook, Estey (2006)

December 20, 2010

Yuko Palesch

 Futility Designs

January 24*, 2011

Jody Ciolino

Modified toxicity probability interval (mTPI)

  TPI.pdf, mTPI.pdf; pdf of Jody’s slides

February 21, 2011

Liz Garrett-Mayer

Likelihood early stopping designs in phase II clinical trials 

 Early stopping for phase II cancer studies:  a likelihood approach (long)

Early stopping for phase II cancer studies:  a likelihood approach (short)

March 21, 2011

Betsy Hill

Seamless Phase I-II Trial Design for Assessing Toxicity and Efficacy for Targeted Agents.

Hoering, LeBlanc, Crowley paper

* this is the 4th Monday, due to MLK Jr Holiday on the 3rd Monday.

 

Some useful references:

Clinical Cancer research volume with focus on Phase I trials

Tutorial on CRM

EWOC (Tighiouart M, Rogatko A, Babb JS.)

BioPharmNet website

 

Ideas for future discussion topics:

Software and resources for implementing early phase trial designs

Phase 0 trials

Dose finding trials in non-toxic agents.

Designing early phase studies with targeted agents.

White papers on BioPharmNet website