FDA Standards Development and Implementation

1
FDA Standards Development and Implementation
Pharm Toxicology Advisory Subcommittee
Meeting June 10, 2003

• Randy Levin, M.D.
• Director, Office of Information Management
• Center for Drug Evaluation and Research
• Food and Drug Administration

2
Overview

• Standards organizations
• FDA Data Council, CHI, HL7, ICH, CDISC
• Initiatives
• Electronic submissions of applications
• Clinical and non clinical study data
• Annotated ECG waveform data

3
Standards Development Organizations

• Government
• e.g., FDA Data Council, Consolidated Health
  Informatics
• Accredited Standards Development Organizations
  (SDO)
• e.g., Health Level Seven (HL7), American National
  Standards Institute (ANSI)
• Other
• e.g., ICH, CDISC

4
FDA Data Council

• FDA Data Council
• Standards development for health and regulatory
  data and terminology for the FDA
• Representatives from all agency centers and
  Office of the Commissioner
• Standards
• Involved in national and international standards
  development efforts

5
Standards Development Process
Centers/Offices Identify data or terminology
standard need
Data Council Coordinate development and promote
implementation
Standard Development Organization
Working group of FDA experts
6
Consolidate Health Informatics

• CHI
• Part of Presidents eGov initiative
• Set healthcare related standards for interagency
  use
• Representatives from government agencies involved
  in healthcare (e.g., HHS, DoD, VA)
• Standards
• Use HL7 messaging standards
• LOINC for laboratory tests terminology
• Others related to primary health care
• DICOM for transmission of radiology images
• NCPDP for prescription messages
• IEEE standard for ECG monitoring messages

7
Health Level Seven

• Standards Development Organization for issues
  related to healthcare information
• Accredited by the American National Standards
  Institute (ANSI)
• Open, international membership
• Involved in standards development activities
• Health Insurance Portability and Accountability
  Act
• National Health Information Infrastructure
• Consolidated Health Informatics
• Technical committees for development of FDA
  standards
• Regulated Clinical Research Information
  Management
• Vocabulary
• Government special interest group

8
ICH

• International Conference on Harmonisation
• Develop standards for communication between
  regulatory authorities and pharmaceutical
  industry
• Representatives from drug regulatory authorities
  in the US, EU and Japan and pharmaceutical
  organizations (i.e., PhRMA, EFPIA and JPMA)
• Standards
• Common Technical Document
• Electronic Common Technical Document
• Individual case safety reports
• MedDRA

9
CDISC

• Clinical Data Interchange Standard Consortium
• Develop standards for communication of clinical
  trial data between pharmaceutical partners and
  between pharmaceutical companies and regulatory
  authorities
• Representatives from vendors, pharmaceutical
  companies, CROs, industry consultants and
  government agencies
• Standards
• Submissions data model

10
Standard Initiatives

• Electronic submissions of applications
• Study reports
• Structured protocols
• Structured Product Labeling
• Individual Case Safety Report
• Electronic MedWatch
• Stability data
• Annotated ECG waveform data
• Study data

11
Clinical and Animal Study Data

• Data standards
• Organization based on CDISC version 3 submission
  data model
• Terminology
• Standard procedures
• Analysis tools
• Repository

12
CDISC Version 3 Submission Data Model

• A study is a collection of observations
• Types of observations
• Interventions
• Therapeutic and experimental treatments
• Events
• Incidences independent of planned study
  evaluations (e.g., adverse reactions)
• Findings
• Observations resulting from planned
  evaluationsons to address a specific question
  (e.g. lab test result)

13
Standard Descriptive Variables

• Observations characterized by descriptive
  variables
• Types of descriptive variables
• Topic
• identifies the focus of the observation
• Identifiers
• identifies the subject of the observation
• Timing
• describes the start and end of the observation
• Qualifiers
• describes the traits of the observation

14
Observations Characterized Using Standard
Descriptive Variables
Example Observation
Subject 101A
nausea
had mild
starting on study day 6
15
Annotated ECG Waveform Data

• Data standards
• Organization based on HL7 RIM version 3 message
• Information transported in XML file
• Standard procedures
• Viewer
• Analysis tools
• Repository