# Presentation: 784652

##      CCOP, MBCCOP & Research Base                            Meeting

- September 17-18, 2007
- Joan K. Mauer, Chief
- Linda McClure, Clinical Trials Monitoring Specialist
- Clinical Trials Monitoring Branch
- Cancer Therapy Evaluation Program
- Division Of Cancer Treatment and Diagnosis
- NCI, NIH

##                        INTRODUCTION

- CTEP/NCI sponsors approximately 135 active INDs at any given time
- Clinical trials are conducted through clinical Cooperative Groups and Cancer Centers
- Approximately 28,000 new patients are enrolled annually in treatment trials

## Overview

- NCI’s Clinical Trials Cooperative Group Program (the “Groups”) is distinctive among NIH-supported clinical trials programs:
- A standing clinical trials infrastructure that is continuously available to test new therapeutic strategies
- Consists of researchers at institutions affiliated with the Groups who jointly develop and conduct trials in multi-institutional settings
- Flexible research agenda allows change of strategy in response to changing scientific opportunities and new discoveries

## U.S. Clinical Trials Treatment Sites(# of Sites by State that Currently have Patients Enrolled on Open Trials)

-  1Dot = 5 sites

**Total Sites = 1,878**
**2004 Data**

**U.S. Clinical Trials Treatment Sites****(# of Sites by State that Currently have Patients Enrolled on Open Trials)**

## NCI Cooperative Group Program 2007:  10 Groups - 9 adult and 1 pediatric

**Multimodality:**
- Cancer and Acute Leukemia Group B (CALGB)
- Eastern Cooperative Oncology Group (ECOG)
- North Central Cancer Treatment Group (NCCTG)
- Southwest Oncology Group** **(SWOG)
- NCI of Canada – Clinical Trials Group (NCIC-CTG)**
**Specialty:**
- American College of Surgeons Oncology Group (ACOSOG)
- National Surgical Adjuvant Breast & Bowel Project (NSABP)
- Gynecologic Oncology Group (GOG)
- Radiation Therapy Oncology Group** **(RTOG)
- Children’s Oncology Group (COG)
- ** NCIC-CTG funding limited to participation in Intergroup trials

##   Cooperative Group QC and QA Program

- Groups have well established QC programs for monitoring data through statistical office
- 1982 on-site audit required for Cooperative Group Program with NCI oversight
- NCI standardized guidelines used to conduct audits
- Each Group institution audited at least once every 3 years

##  Data Monitoring
Continuous process through-out the trial
Off-site
 Includes all patients 
     on the trial

- Continuous process through-out the trial
- Off-site
-  Includes all patients
-      on the trial

-  Auditing
- Independent review at one point in time
- On-site
- Based on PI & Institution, subset of patients on trial

**Data Monitoring *****vs***** Auditing**

*Both include expert Medical Review within the NCI Cooperative Group System with On-going Education for all Group Members**** ***

## NCI Cooperative Group On-Site Audit Program

**Audit Program is Based on Institutions NOT specific trials**
**Purpose of the on-site Audit Program:**
**Document accuracy of data submitted to Groups with independent verification of study data with source documents**
**Verify investigator compliance with protocol & regulatory requirements**
**Serves as an educational tool opportunity for audit team to share with institution staff information on data quality, data management, & other aspects of QA**

## NCI Cooperative Group On-Site Audit Program

**3 Components of Audit:**
**IRB/Regulatory (IRB documentation; Content IC; AE & Safety Reports)**
**Pharmacy (NCI DARFs; shipping/returns; shelf count, check pt records)**
**Patient Case Review (Source Data Verification – Protocol Compliance)**
**Informed Consent**
**Eligibility**
**Treatment**
**Toxicity**
**Data Timeliness - Quality**

## NCI Cooperative Group On-Site Audit Program

- Audit program based on institutional performance under a Principal Investigator for Cooperative Group at that site
- Auditing program is a independent review process with an educational component
- NCI standard guidelines for conduct of audits & requires all institutions be audited at least once every 36 months but all sites at risk for audit at any time (e.g., special audits)
- Clinical Trials Monitoring Branch (CTMB) at NCI/CTEP has direct oversight responsibility for the audit system
**Conducts Co-site visits on about 10% of all audits  **
**CTMB Auditing Guidelines publicly available at: ****http://ctep.info.nih.gov/monitoring/guidelines.html**