drug safety management safety is good business

Drug Safety ManagementSafety is good business.

Potential for Extracting Data from Sample Databases

January 31, 2003

Y. Renee Lewis, Chief Operating Officer

Life Sciences Research OfficeEvaluating Adverse Event Systems for

Dietary Supplements

Company Proprietary 2

Agenda

About QED Solutions, Inc.

Data Considerations

Analyzing the Data

Research Capabilities

Summary

About QED Solutions


QED Overview

Company Focus: Web-based Drug Safety Management Solutions – product with supporting services.

Sophisticated analytical tools that support pharmacovigilance and safety surveillance investigations

Research capabilities to aid medical professionals in finding and understanding patterns of drug behavior provided in details of adverse event data

Services: Implementation, application hosting, data validation, data extraction/aggregation, data extensions, limited research (primarily with partners)

Client-base: 22 major pharmaceutical and bio-technology firms.

Primarily Global Safety Office, Medical Affairs or Epidemiology.


Product Overview - QscanTM

Products: One research solution, access multiple data setsOne research solution, access multiple data sets

QscanTM FDA – subscription service to AE data released from the FDA through FOIA

QscanTM World – subscription service to AE’s received by the WHO at Uppsala Monitoring Center representing 67 countries (CIOMs and MedWatch forms)

QscanTM PRO – internal application to review data collected at a pharmaceutical company

Statistics: Proportional analysis, frequency profiling, correlations, comparisons

Others: Automatic detection alerts to simplify monitoring of hypothesis

Research capabilities to aggregate independent cases into series for analysis


Product Maturity12/1998 Founded by Victor Gogolak to develop solutions for pharmacovigilance

10/1999 Begin development of first product (data and application

06/2000 QscanTM Alpha released at DIA conference, Glaxo first Alpha customer

10/2000 QscanTM FDA 1.0 released to public

12/2000 Roche purchased – first production customer

06/2001 QscanTM FDA 1.2 released

09/2001* QscanTM FDA 1.5 released (General Release Product)


04/2002 QscanTM FDA 1.6.1 released

06/2002 QscanTM World alpha released

08/2002* QscanTM World 1.7 released


03/2003 QscanTM FDA 2.0 and World 2.0

Aggressive release schedule includes:

• Data manipulation features• Analytic techniques• Data sets or updates

Aggressive release schedule includes:

• Data manipulation features• Analytic techniques• Data sets or updates


Using Tools

What you can do with tools:

Monitor and detect requested patterns in the data Research general patterns and trends Probe and analyze hypothesis Show how the reported data compares consistent with proposed

populations Identify strength of association between elements in a set of cases Compare two different sets of data Store saved results and data for future review, comparison Export data for additional analysis or reporting

What QscanTM does not do:

Provide “answers” – medical judgment is required Show causality – must use other methods Directly support regulatory reporting process

Data Considerations


Data Issues - General

Data Availability – no “good source” for herbals, vitamins or OTC’s

No regulation to drive data collection – voluntary No regulation around data review or analysis No source specific to this domain

– Safety is a public policy issue – Does data makes a company possibly vulnerable

OR does it provide a competitive advantage?

Data Quality

Limited training on data collection for these items – data collected by accident!

Data collection poor, not controlled Many consumer reports with no medical follow up Lack of integrity of data relationships (e.g., time to onset) FDA and World only report “serious and unexpected” – bad things


Data Considerations with QscanTM SourcesQscanTM FDA (through FOIA or other 3rd party)

FDA data released under FOI in “raw” form (verbatim terms) Released quarterly - approximately 6 month latency Nov 1997 to present - Adverse Event Reporting (AERs); MedDRA reaction

dictionary (very old release) 1969 – October 1997 - Spontaneous Reporting System (SRS); COSTART mapped

to MedDRA Regulations to control volume of data – severe and unexpected

QscanTM World World Data – 67 countries – CIOMs except US Includes FDA data, but only “non-consumer” reports WHO-ART reaction dictionary; WHO-DD Some noticeable latency in data collection (years in some countries)

QscanTM PRO Internal data – Post Market and Clinical Trial World Health Organization – Uppsala Monitoring Centre Clinical Trials


Sample Data

Dictionary mappingsand aggregations

Suspect vsnon-suspect


Verbatims (Show Source)


Data Examples – Case Listing

Follow-on processing

Reactions – MedDRA terminologyDuplicates? Twins?


Sample – Case Detail

All the data is made available to review every known detail.

Additional elements can be easily added.


Other Possible Data Sources

Commonly used for analysis

Consumer reports to the company GPRD (General Practice Research Database) Claims data Registries

Uncommonly used, commonly used as data extenders

Prescription data - denominator Medical records (closed systems like Kaiser Permanente) Medical records with claims data (hard to find) Genomic databases, Toxicology data Internet sites

Requirements for use

Structured Coded (dictionary, reactions, outcomes, demographics)

Analyzing the Data


If it’s so bad, why use this data?

Availability ….Many AE’s include herbals, vitamins and OTCs as a by-product of the process

Severely under reported, but can assume that the under reporting is uniform

Many herbals, vitamins and OTCs have been around for a long time – our data goes back to 1969

Patterns may emerge using more sophisticated techniques:– Proportional Analysis– Correlation

Reactions are coded (MedDRA and WHO-ART) Drug names are mapped and can be remapped easily Available today, immediately


Analytics

Common output with these data

Rates and counts Proportional reporting rates – “out of norm” Odds Ratio (where appropriate) Correlations Comparisons – standard backgrounds, other data sets Trends

Ability to export data from the system

Continued analysis and imaging Documentation Information sharing

Requires structured information

Dictionaries and terminologies Setup for both analysis and research (drill-down)


Research Social Circumstances – PRR 2.98

Details• Case 3570383Drug abuser

• Case 3618733Refusal of treatment

Primary suspect on both!

Positive Dechallenge

Research Capabilities


Case Series and Search Criteria

Ability to group cases based on criteria, for example

Reactions Concomitants Demographics Report dates Outcomes Medically significant

Methods to find “difficult” groupings, for example

Cases where these two drugs occur together Cases with this drug or that drug Cases where this drug occurs, but not that drug Cases with only these reactions

Ability to review out put and refine criteria based on results

Facility to share results with interesting information or comments


What’s it take to make data “analyzable?”Structured data for elements coded to terminologies, where possible

Drug/compounds (primary, concomitants, suspect drugs and why) Reaction Terms Outcomes Demographics

Additional information is a plus to increases capabilities and understanding

Condition data Time to onset Report dates

Good intake procedures improve the data quality

Handling of consumer reports Medical review of reports Data collection tools and automation procedures Application and data access for review, follow-up and analysis Methodologies – passive and active

Summary


Summary

Not much available today, so make the most of what’s there

You can use what is available to your advantage with the “right” approaches

Tools and software frameworks make the task less arduous, data readily available

Better data sources for herbals and vitamins are sorely needed

Qscan-like tools can be used against any spontaneous data source with some minimal effort

Dictionaries, standard terminologies and proper mapping techniques make the data systematically available

drug safety management safety is good business

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