LECTURE 23 2011

LECTURE 23 2011 - Interim Analyses of Clinical Trials A...

Info iconThis preview shows pages 1–13. Sign up to view the full content.

View Full Document Right Arrow Icon
Interim Analyses of Clinical Trials A Requirement
Background image of page 1

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
Outline Background and how DSMBs arose and function Group sequential methods Examples
Background image of page 2
Suggested Reading Ellenberg S, Fleming TR, DeMets DL Data Monitoring Committees in Clinical Trials. A Practical Perspective John Wiley & Sons, LTD, 2002
Background image of page 3

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
Research on Human Subjects and Data Monitoring Committees Nuremburg Code (1949) Declaration of Helsinki (1964) Belmont Report (1979) Greenberg Report (1967) FDA Guidance on DMCs (2006)
Background image of page 4
Structure for Cooperative Studies (Greenberg Report) Policy Board or Advisory Committee National Advisory Heart Council Initial review group Institute staff Executive Committee or Steering Committee Coordinating Center Participating Units Cont Clinical Trials 9:137-48, 1988.
Background image of page 5

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
Monitoring Committee Acronyms PAB = Policy advisory board DSMB = Data and Safety Monitoring Board DMC = Data Monitoring Committee ESMB = Efficacy and safety monitoring board OSMB = Observational study monitoring board
Background image of page 6
Responsibilities Steering Committee Study design Patient recruitment and follow-up Data collection Quality assurance Study reports DMC or DSMB Safety of patients Protection of integrity of study Review of blinded data on safety and efficacy of treatments Review of trial conduct, amendments and external data
Background image of page 7

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
Starting Point A randomized study Uncertainty with respect to the relative safety and benefits of treatments to be compared Protocol to address the scientific question Informed consent with explicit or implicit mention of interim monitoring Plan for timely data collection and safety monitoring
Background image of page 8
In the End Want… Confidence in the answer A report in which you can specify: - Number of interim analyses - Reason for stopping, if early - Monitoring guidelines used - DSMB membership
Background image of page 9

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
Interim Analyses Rationale Safety is best assured by comparing the rate of adverse events with a control group Studies should not stop before there is a definitive answer and should not continue longer than necessary to obtain one Regular assessment of the relevance of the question Regular assessment of whether the trial will address the question posed There are ethical, scientific and economic reasons for interim monitoring of data for clinical trials.
Background image of page 10
Reasons for Early Termination of Clinical Trials Based on accumulated data from the trial: Unequivocal evidence of treatment benefit or harm Unexpected, unacceptable side effects No emerging trends and no reasonable chance of demonstrating benefit Based on overall progress of the trial: Failure to include enough patients at a sufficient rate Lack of compliance in a large number of patients Poor follow-up Poor data quality
Background image of page 11

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
Today All NIH sponsored clinical trials are required to have a data monitoring plan NIH-sponsored trials with clinical endpoints have a DSMB Many industry sponsored studies have a DSMB
Background image of page 12
Image of page 13
This is the end of the preview. Sign up to access the rest of the document.

This note was uploaded on 11/21/2011 for the course PUBH 7420 taught by Professor Ph7420 during the Spring '07 term at Minnesota.

Page1 / 41

LECTURE 23 2011 - Interim Analyses of Clinical Trials A...

This preview shows document pages 1 - 13. Sign up to view the full document.

View Full Document Right Arrow Icon
Ask a homework question - tutors are online