Learning : Short Courses


Data Monitoring Committees: Role of the Statistician

Scott S. Emerson, MD, PhD

June, 2014

Abstract: During the conduct of a randomized clinical trial, it is commonplace for the accruing data to be regularly monitored by a committee of independent researchers in order to assure patient safety and ethical conduct. Typically such committees are comprised of 3-5 members, including clinicians expert in the disease under study, the treatment, and/or any expected toxicities, ethicists, and a biostatistician. It is incumbent upon all members of the data monitoring committee (DMC) to collaborate fully with each other in their highly interdisciplinary task. In this short course, we will elaborate on the role of a DMC statistician in this process. We consider the review of the DMC Charter, the investigator's brochure, the protocol, and the statistical analysis plan from a DMC statistician's viewpoint. We then discuss the elements of a DMC report that will be commonly encountered, and the organized approach to the review of the data. We discuss our experience with commonly encountered problems that require particular input from the independent DMC statistician. The course is targeted to individuals who might serve on a DMC as well as those who might author the reports to a DMC.

Course Materials (pdf):   Presentation Handouts

                                     Example Protocols (from Internet):  NSCLC   CKD  GI bleeding  Obesity   Diabetes  Vasculitis

                                     Example DMC Report:                    anti-VEGFR in Metastatic NSCLC

Video Slideshows:  

  1. 1. Introduction:

  2. Clinical trial setting

  3. (Slides 1-26) (26:11)

  1. 2. Case Studies:

  2. Examples of issues in monitoring RCT

  3. (Slides 27-43) (11:54)

  1. 3. DMC Organization:

  2. Membership and functioning of DMC

  3. (Slides 82-110) (19:35)

  1. 4. Review of Documents:

  2. Review of Protocol in preparation for DMC

  3. (Slides 111-128) (08:37)

  1. 5. Review of DMC Report:

  2. Review of an Example DMC Report

  3. (Slides 190-197) (34:02)

Learning Material:

  1. Short Courses

  2. Research Talks

  3. Case Studies