# Presentation: 204671

## The CDER 2001 

**Good Review Practices**

***Lisa Rarick, MD***
**Center for Drug Evaluation & Research**
***Review Standards Staff/QA Program***
**Food and Drug Administration**

- DIA 37th Annual Meeting
- Denver July 10th, 2001

**The CDER 2001 **
**Good Review Practices Initiative**
***Clinical***

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## GRP Initiative--Clinical

**Good Review Practices**

**GRP Initiative--Clinical**

***History***
***Current Status***
***Challenges***
***Future***

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***Clinical***

## History

**Good Review Practices**

**History**

***1994 Consensus Action Plan--Clin/Stat***
***11 “Tracks”***
*** ******Coordination, evolution, policy database, IND, data-handling, personnel, project development, content/format, internal communications, consensus document, training***

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***Clinical***

## GRP--Template

**Good Review Practices**

**GRP--Template**

***Table of Contents Template effective March 30, 2001***
***One-year implementation***
***Feedback--written, interviews, audits, all-hands/brown bag sessions, working group***
***Final with Guidance--Spring, 2002***

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***Clinical***

## Standard Review Template

**Good Review Practices**

**Standard Review Template**

*** ******Cover Sheet***
***Table of Contents***
***Executive Summary***
***Clinical Review***
***Intro/Background***
***Clinically relevant findings from other disciplines***
***PK/PD***
***Clinical Data description and source***
***Clinical Review methods***
***IRE, IRS***
***Dosing, Regimen, Administration***
***Special Populations***
***Conclusions/Recommendations***

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***Clinical***

## Executive Summary

**Good Review Practices**

**Executive Summary**

***Recommendations***
***Approvability?***
***Phase 4 studies and/or risk management steps?***
***Summary of Clinical Findings***
***Orientation to the Review***
***“******Stand alone” document***
***Not recapitulation of assessment process***
***Language appropriate for the educated lay reader***

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***Clinical***

**Notes:**
Review Templates and Executive Summary

1.  Leveraging information to support quality, safety, and efficacy

2.  Provide sponsors with a knowledge of application requirements

3.  Guide Reviewers to utilize the information provided by sponsors

GRP Web page

Workroom
Resource Room
Document Control
Dialog
Training

## Executive Summary--Continued 

**Good Review Practices**

**Executive Summary--Continued **

***Brief  (eg 5 pages)***
***Overview of Clinical Program***
***Efficacy***
***Claim/population***
***Size of effect***
***Relationship of endpoint to pt benefit***
***Relationship to other drugs available for the indication***
***Resolved and unresolved issues***

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***Clinical***

**Notes:**
Systemic Approach

(integration of CDER disciplines, clinical divisions, internal consultant and service functions, and management)

Functional feedback mechanisms
- one-on-one dialog
- small discussion groups
- larger forums and workships

Focus on functional feedback mechanisms  
one-on-one dialog
small discussion groups
larger forums and workshops

## Executive Summary--continued

**Good Review Practices**

**Executive Summary--continued**

***Safety***
***Adequacy of testing***
***Serious side effects, common side effects***
***Relationship of side effects to known tox***
***interaction potential***
***trial exposure/effect vs anticipated market exposure/effect***
***warnings***
***relationship to other drugs available for indication***

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***Clinical***

**Notes:**
Systemic Approach

(integration of CDER disciplines, clinical divisions, internal consultant and service functions, and management)

Functional feedback mechanisms
- one-on-one dialog
- small discussion groups
- larger forums and workships

Focus on functional feedback mechanisms  
one-on-one dialog
small discussion groups
larger forums and workshops

## Executive Summary--continued

**Good Review Practices**

**Executive Summary--continued**

***Recommendations***
***Summary of Clinical Findings***
***Overview***
***Efficacy***
***Safety***
***Dosing***
***Special Populations***

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***Clinical***

**Notes:**
Systemic Approach

(integration of CDER disciplines, clinical divisions, internal consultant and service functions, and management)

Functional feedback mechanisms
- one-on-one dialog
- small discussion groups
- larger forums and workships

Focus on functional feedback mechanisms  
one-on-one dialog
small discussion groups
larger forums and workshops

## Challenges/Future

**Good Review Practices**

**Challenges/Future**

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*** ******Clinical***

***  ******Format compliance***
***  ******Content standards***
***  ******Safety Document, Evidence Doc, ICH and other guidance criteria, etc***
***  ******Target Audience, access to reviews***
***  ******Other Standard setting***
***  ******IND review standardization--Format and Content***
***  ******Meeting preparation standards***
***  ******Secondary and Executive Review Standards***
***  ******Communications and Training, Process Development***

**Notes:**
Systemic Approach

(integration of CDER disciplines, clinical divisions, internal consultant and service functions, and management)

Functional feedback mechanisms
- one-on-one dialog
- small discussion groups
- larger forums and workships

Focus on functional feedback mechanisms  
one-on-one dialog
small discussion groups
larger forums and workshops

## Acknowledgements

**Good Review Practices**

**Acknowledgements**

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*** ******Clinical***

***Office of the Center Director  ***
***Office of Medical Policy***
***Center for Biologics Evaluation and Research***
*** ******Review Standards Staff--***
***Michael Ortwerth, PhD--Project Lead***
***Judy McIntyre, Ruby Jordan ***
***Working Groups, Feedback teams, Process Teams***
***Multidiscipline work***

**Notes:**
Systemic Approach

(integration of CDER disciplines, clinical divisions, internal consultant and service functions, and management)

Functional feedback mechanisms
- one-on-one dialog
- small discussion groups
- larger forums and workships

Focus on functional feedback mechanisms  
one-on-one dialog
small discussion groups
larger forums and workshops