ns1450x - computerized systems in clinical research

Computerized

Systems in

Clinical Research

(NS1450X)

eClinical - Computerized Systems in Clinical Research (NS1450X)

The rapid adoption of computerized systems in the management of clinical trials is quickly changing not only the dynamics

of clinical trials but also redefining the roles of individuals working in the field. While the focus of a clinical trial will always

ultimately be on the safety of the patients, eClinical applications now impact everything from case report form collection, to

how often sites are monitored, to communication with the patients. This course focuses on understanding how sponsors,

contract research organizations, hospitals, universities, clinical investigators and you are being impacted by the movement

to eClinical applications. While the instructor will be showing various computer applications as part of the course, students

will not be hands-on, will not need computers nor need to be "tech-savvy". The goal of the course is to exposure you to the

eClinical applications that you will most likely work with as a CRA or CRC.

Pre/Co-Requisite: Essentials of Initiating Clinical Research (NS14601 or NS14602 or NS14603)

NS1450X Agenda

6:00PM

15 Mins

Introductions

15 Mins Review of Clinical Trials; all Phases

60 Mins

Electronic Data Capture (EDC)

Clinical Trial Management Systems (CTMS)

7:30PM

Break till 7:45PM

45 Mins

Risk Based Monitoring (RBM)

20 Mins Questions and Clarifications

8:50PM Close

Introductions

1. Your Name

2. Have you taken the Essentials of Initiating Clinical

Research course? The Healthcare Statistics course?

3. Working in the Clinical Trial Industry now?

4. What would you like to learn from this course?

Introductions

1. Your Name – Judson Chase

Research course? The Healthcare Statistics course? –

About six years ago

3. Working in the Clinical Trial Industry now? – Indirectly

4. What would you like to learn from this course? –

Comfort with the “tools” of clinical research

Judson Chase - clinical trial experience

• Abbott Nutrition

• AbioMed

• AmeriPath

• AmerisourceBergen

• Amgen

• Apex International

• Astellas Pharma

• AstraZeneca

• Bausch and Lomb

• Bayer

• Baxter Healthcare

• Biogen Idec

• BioMarin

• Biomet

• Boehringer-Ingelheim

• BostonScientific

• Bristol-Myers Squibb

• Celgene

• Cochlear

• Covance

• Covidien

• CR Bard

• CSL Behring

• Kyphon

• Lifeline

• Lifescan (J & J)

• MEDRAD MDS Pharma

• Medimedia

• Medpace

• Medtronic

• Merck

• Millennium Pharma

• Nestle

• Novartis

• Novo Nordisk

• Novotech

• NxStage Medical

• Paratek

• Pfizer

• PharmaNet

• Phillips Healthcare

• PRA International

• Purdue Pharma

• Quark Pharma

• Quest Diagnostics

• RadPharm

• Daiichi Sankyo

• deCODE Genetics

• ELAN

• Eli Lilly

• eMed

• Galderma

• GE Healthcare

• Genzyme

• Genzyme Genetics

• Gilead

• Greatbatch

• Grünenthal

• Hill-Rom

• Hologic

• ICON

• Idenix

• ImClone

• Infinity Pharma

• Ingenix

• Invacare

• Johnson & Johnson

• Kaiser Permanente

• KCI

• Regeneron

• Roche Diagnostics

• Salix Pharma

• Salter Labs

• Sanofi

• Schering-Plough

• Sepracor

• Simpirica Spine

• St. Jude Medical

• St. Michaels Hospital

• Stryker Endo

• Stryker Neuro

• Stryker Ortho

• Sunovion

• Trident Clinical Research

• Tyco Healthcare

• Ultradent

• United Therapeutics

• University of Toronto

• Vertex

• Warner Chilcott

• Zimmer

• Zoll Medical

Introductions

1. Your Name

Research course? The Healthcare Statistics course?

3. Working in the Clinical Trial Industry now?

4. What would you like to learn from this course?

NS1450X Agenda

6:00PM

15 Mins

Introductions

60 Mins

7:30PM

Break till 7:45PM

45 Mins Risk Based Monitoring (RBM)

8:50PM Close

Computerized Systems in Clinical Research NS1450X

March 20, 2013 - http://www.clinipace.com/the-dcro-streamlining-16-databases-into-one-single-platform

Computerized Systems in Clinical Research NS1450X

Why do Sponsors run Clinical Trials?

• To assist in the advancement of medical science

• Drug and Medical Device makers need to be sure that a

drug or medical device is safe

• Drug and Medical Device makers need to determine

whether a Drug or Medical Device is effective at treating

a certain condition

• For the Life Sciences industry to make a profit

To disprove the null hypothesis via data

Phase I Clinical Trials

• Initial introduction of an investigational drug into humans, generally using healthy volunteers *

• Goal : Assess drug safety and dosage

in humans • Studies evaluate absorption,

distribution, metabolism and elimination (ADME) of the drug, side effects, and determine maximum tolerated doses (MTD)

• Few subjects (20 – 80)

* Although Phase I studies in most therapeutic areas consist of healthy patients, Phase I studies in oncology consist of patients with active disease.

Phase I Clinical Trials

*MTD (maximum tolerated dose ) --the highest dose for which no more than 1 of the 6 treated patients exhibits DLT (dose-limiting toxicity )

Phase I Clinical Trials - LabPas (Oracle)

Phase II Clinical Trials

• Determines common short-term side effects and risks

• Goal : Assess efficacy and safety and

further evaluate the proposed dosage from Phase humans

• Conducted in the target population

• Determines the best dose for the

target population and how often it should be given

• Few subjects (100 – 300)

Phase III Clinical Trials

• Definitive efficacy studies for regulatory submission and approval

• Goal : Gather pivotal efficacy / safety

information needed to evaluate the overall risk-benefit ration of the drug in the target population

• Usually conducted in hundreds or

even thousands of subjects at multiple sites

• Two to three years+ in duration

Phase IV Clinical Trials

• Studies can continue after approval application is submitted

• Goal : After approval, continue to

assess long-term safety • May be required as part of Regulatory

Agency approval

• Paper Patient Dairies and ePRO (electronic patient reported outcome)

“Virtual” Clinical Trials

• Pfizer and Mytrus • From home via Internet, mobile phone

and snail mail • Overly complex enrollment process

hampered recruitment

• Designed for US; consideration to modify for European regulators’ needs

• Search YouTube for “Mytrus At-Home Online Knee Osteoarthritis Clinical Trial”

http://www.youtube.com/watch?v=0fEx5V45zp4

HEOR Clinical Trials

• Health Economics analyses • Outcome Research analyses • Not empirical in nature (i.e., no

Protocol involved)

• Could be just data from past trials

• Could be subjective data (i.e., Truven or Micromedex)

• Think “dollars”; not just “data”

NS1450X Agenda

6:00PM

15 Mins

Introductions

60 Mins

7:30PM

Break till 7:45PM

8:50PM Close

Paper Case Report Forms vs. EDC

Report

Overview of Paper CRF Process Flow

Medical Term Coding by

sponsor CDM personnel

Database Soft Lock by sponsor CDM personnel

Check of validity of data by CRA

during monitoring visit

Double data entry by sponsor CDM

personnel

CRF Collection by CRA

Quality Control Checks by

Load External Data by sponsor CDM personnel

Database Hard Lock by sponsor CDM personnel

Monitoring Visit Query Resolution

by CRA and investigator

Query Generation by sponsor CDM

personnel

Collection of subject data in source notes & paper CRF by investigator

EDC Is Now Used For Over Half Of All Phase II

Trials and Almost All Of Phase III Trials

Source: Health Industry Insights, “Business Strategy: U.S. Electronic Data Capture 2008–2014 Spending Forecast and Analysis”, 2010

U.S. Electronic Data Capture Adoption by Segment, 2008-2014

Overview of e-CRF (EDC) Process Flow

Medical Term Coding by

Database Soft Lock by sponsor CDM personnel

Collection of subject data in source notes by site personnel

Online direct transfer into

database by site personnel

Completion of eCRF by site personnel

Quality Control Checks by

Load External Data by sponsor CDM personnel

Database Hard Lock

By sponsor CDM personnel

Query resolution by investigator

Query Generation by sponsor CDM

personnel

Medidata Rave (EDC) screen capture

Oracle RDC (EDC) screen capture

REDCap (EDC) screen capture

PhaseForward InForm (EDC)

Digital Medicines: Proteus Digital Health

Trademark Proteus Biomedical

Digital Bio-Medical Devices: Google Inc

Digital Bio-Medical Devices: Fit bands

Monitoring

Reports

Perceptive TrialWorks (CTMS)

ClinPlus (CTMS)

Siebel Clinical (CTMS)

CTMS demonstration

Break at 7:30PM

NS1450X Agenda

6:00PM

15 Mins

Introductions

60 Mins

7:30PM

Break till 7:45PM 45 Mins Risk Based Monitoring (RBM)

8:50PM Close

NS1450X Agenda

6:00PM

15 Mins

Introductions

60 Mins

7:30PM

Break till 7:45PM

45 Mins

8:50PM Close

Essentials of Initiating Clinical Research NS1460X

Math and Clinical Trials

RBM. . . what is Risk Based Monitoring?

Risk Based Monitoring (RBM) Disciplines

RBM KRI Dashboards

Adaptive SMV & SDV Enrichment Strategies

Fraud Detection Enrollment Monitoring

QMS / GCP Compliance

Site Initiation

Enrollment Prediction

RBM. . . what is Risk Based Monitoring?

30May2013

RBM Applied to Clinical Trials For Centralized Monitoring, Project Management, CRA’s

Which of my sites are most “problematic”?

Which sites should I visit next week?

How long should I plan to spend at each site?

RBM demonstration

NS1450X Agenda

6:00PM

15 Mins

Introductions

60 Mins

7:30PM

Break till 7:45PM

8:50PM Close

Computerized Systems in

Clinical Research (NS1450X) eClinical - Computerized Systems in Clinical Research (NS1450X)