jmp clinical: roadmap and case studies · pdf filecopyright © 2013, sas institute inc....

Copyright © 2013, SAS Insti tute Inc. Al l r ights reserved.

JMP CLINICAL:

ROADMAP AND CASE STUDIES

GEOFFREY MANN, PHD

JMP LIFE SCIENCES PRODUCT MANAGER


DRUG DISCOVERY

AND DEVELOPMENT

PROCESS

A drug can be defined as any compound

introduced into a living organism, animal or

human, in order to prevent or to cure a

disease, only to attenuate symptoms, or to

establish a diagnosis

Copyright © 2013, SAS Insti tute Inc. Al l r ights reserved.3

LeadCompound

BiologicalTests

PrepareIND

Phase I Phase II Phase IIIPrepare

NDALaunch

FormulationDevelopment

FormulationDevelopment

Process Research

PilotDevelopment

Commercial Plant Transferand Start-Up

Discovery Pre-Clinical Development Clinical Trials Approval & SM

Product Development

Process Development

Years: 0 2 7 9

NEW CHEMICAL/BIOLOGICAL ENTITY TIMELINE (FROM DISCOVERY TO LAUNCH)

Biomarkerdiscovery

Target and Lead Identification &

Validation

JMP/JMPG JMP ClinicalJMP Clinical JMP Clinical

JMP JMP/JMP PROJMP

JMP


CLINICAL

BIOINFORMATICS

Health Data Integration

Patient Data

Demographic Clinical Data

GWAS RNA Expression

ProteomicsFlow

CytometryBioassay

SCIENTIFIC

Prepare For Analysis


LIFE SCIENCES R&D TEAM


RUSS WOLFINGER

• http://blogs.sas.com/content/jmp/2012/12/05/russ-wolfinger-elected-2012-

aaas-fellow/

• Analytically Speaking: https://www.youtube.com/watch?v=QAumH0Uf6rA

http://blogs.sas.com/content/jmp/2012/12/05/russ-wolfinger-elected-2012-aaas-fellow/


RICHARD ZINK


MEDICAL WRITERS


MEDICAL WRITERS ADVERSE EVENT NARRATIVES

The goal of a medical writer is to create narratives for the Clinical Study Report

(FDA Submission document) for Serious Adverse Events, Permanently

Discontinued Subjects, Adverse Events of Special Interest and Adverse Events

associated with Specific Standard MedDRA Qeuries (disease associated

adverse events).


MEDICAL

WRITINGTRADITIONAL VS. JMP CLINICAL

Traditional

• Outsource to CROs, Medical Writing

Services Companies

• Price per study or subject population

• Time consuming

• Requires quality and validation with

data sources

• Requires access to sensitive data

JMP Clinical

• Generate 100s of narratives in seconds

• Modify text for Medical Writers Needs

• Keep Templates for Therapeutic Areas

• Limit Access to data

• Deploy Narratives with Interactive

Patient Profiles to Writers

• Provide access to more safety and

efficacy reports


MEDICAL MONITORS


MEDICAL MONITORS SAFETY AND EFFICACY

The goal of a medical monitor is to evaluate the safety (adverse events) and

efficacy (questionairres) of the patients. Often blinded (they don’t know the

treatment) data as the trial is ongoing it is very important to them to look at

Adverse Events, Labs, Concomitant Medications and other data before they go

into the Data Safety Monitoring Board (DSMBs) at the end of the

week/month/etc… In early phases (I or IIA), this evaluation can help determine

the proper dose. In later phases it is more straightforward to look for outliers

with safety signals.


MEDICAL

MONITORINGTRADITIONAL VS. JMP CLINICAL

Traditional

• Tables Figures and Listings

• Slow Interaction between Medical

Staff and Biometrics/Biostatistics

• Disconnection between Tables and

Patient Profiles

• Pricing for these users tends to be on

a per study basis.

JMP Clinical

• Speed up communication between

various parties

• Specialized Visualizations for Safety

and Efficacy

• Ease of use with built-in workflow

• Immediate access to patient profiles

and patient narratives from any

visualization or table

• Feedback from Regulatory Agencies


CLINICAL OPERATIONS


CLINICAL OPERATIONSCENTRAL STATISTICAL (DATA INTEGRITY) AND

RISK-BASED MONITORING

The goal of clinical operations is to determine what safety and data quality risks

are present in a clinical trial, risks that could potentially hinder a regulatory

submission or drug approval. The risk-based monitoring methods of

TransCelerate Biopharma and other statistical monitoring techniques can help

users identify data anomalies, and perform further investigation to determine

whether factors related to the patients, clinical sites, vendors, or the sponsor

are responsible for lapses in safety or data quality.


CLINICAL

OPERATIONSTRADITIONAL VS. RISK-BASED

Traditional

• Monitoring visit set on predetermined

schedule

• All studies and sites treated equally

• Lower Site Monitor productivity

• Up to 1/3 (some say ½) of trial costs

• Human review is only 85% accurate

• 95% of data findings were or could have

been identified from database

Risk-Based Monitoring

• Visits driven by:

• Workload

• Quality

• Safety signals

• Site Monitor productivity focus:

• Subject safety

• Data integrity

• Regulatory compliance

• Provides insight for data trends across

time, patients, monitors, investigators

and clinical sites


CLINICAL

OPERATIONS/BIOST

ATISTICS

TRADITIONAL VS. CENTRALIZED STATISTICAL

MONITORING

Traditional

• Monitoring visit set on predetermined

schedule

• All studies and sites treated equally

• Lower Site Monitor productivity

• Up to 1/3 (some say ½) of trial costs

• Human review is only 85% accurate

• 95% of data findings were or could have

been identified from database

Central Statistical Monitoring

• Patient/Site performance using the

following methods


BIOSTATISTICS


BIOSTATISTICIANS


BIOSTATISTICS SUPPLY SAFETY DATA AND SUPPORT FOR MANY TEAMS

The goal for biostatistics is to help users identify important safety differences

between treatments, and, similar to the statistical monitoring techniques above,

support operational aspects of clinical trials that may not receive attention from

statisticians due to workload in other areas.


BIOSTATISTICS TRADITIONAL VS. JMP CLINICAL

Traditional

• Tables, Listing, Figures

• Prepare SDTM data

• Prepare ADaM data

• Prepare raw data

• Submission ready data and metadata

JMP Clinical

• May be like Clinical Operations

• Support Medical Monitors by creating

our dashboards

• Evaluate ADaM data with our reports


REGULATORY AGENCIES


REGULATORY

AGENCIES

• Safety and Efficacy Views

• SAS Panels

• Subgroup Analysis

• Data Integrity Views

• Patient vs Site Anomolies

• Relative Risk and Odds Ratios

• Hy’s Law


FUTURE DIRECTIONS


FUTURE

DIRECTIONS

• Benefit Risk Assessment

• WHO Drug

• Continued Improvement of the

User Interface

• Clinical Events

• Therapeutic Area

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