PRESENTED BY

-SANDESH MHATRE

-SANJEEV YADAV

-SARVAJNYA TATTU

-SHANTANU PATIL

-SHWETA SAWANT

MSc. CR (2010-12)

8th June, 2011

Introduction

IT Applications

Future Application

Government Initiatives

Advantages

Challenges

Conclusion

Information Technology is the use of hardware, software, services, and supporting infrastructure to

manage and deliver information

Financial challengesNeed for greater access to capitalInability to provide evidence of return on

investment

Technical challengesComplex and lengthy implementation processesLack of uniform standardsReluctance towards integrating and incorporating

changes to business processes

Cultural challengesLack of leadership support from the public and

private sectorsResistance by health care providers

A way of life, and a mark of civilized society

We outsource everything Products Services

CLINICAL TRIALSThe Way We Make Progress Against Disease

CONTRACT RESEARCH ORGANIZATION (CRO)

In the field of Clinical research the organization that does research on a contract for a sponsor is known as a Contract Research Organization (CRO)

Reasons for Outsourcing Clinical Trials:

Demanding regulatory environment Complexity of trial design and logistics Need for multiethnic population Increase in number of patients and duration of

follow up Long duration of clinical development Delay in recruitment Cost of development

o Refers to the use of electronic systems for automation of clinical trials

o Primary electronic processes are used to plan, collect, access, exchange, archive data

Reasons for this interest are: Advances in information technology The increasing cost of drug Desire to detect drug safety problems sooner.

CLINICAL TRIAL MANAGEMENT SYSTEMS

DATA COLLECTION

2. Direct Data Capture (DDC): Lab test data and ECG results are electronically

transmitted from lab to sponsor’s clinical database.

3. Electronic capture of Patient-Reported Outcomes (ePRO)

Traditionally subjects keep a daily log of their • study medication • dosing times and• log of their symptoms.

Now, subjects are being asked to directly enter data into computers, portable electronic devices

Data is keyed into database management systems (DBMS) directly.

Even when the data is collected on paper case report forms, it is keyed into DBMS.

Software such as SAS ® or Oracle ® to analyze data

Software such as SPSS ® ’s Clementine, SAS ® Enterprise Miner for Data mining

(DBMS)

EHR (ELECTRONIC HEALTH RECORDS)

o Electronic Health Records give immediate electronic access to patient- and population-level information by authorized users

o EHR improves the quality of Clinical Data, makes it more easily accessible, and more useful for safety, outcomes, and other types of analyses.

EHRs TODAY•Fragmented•Limited accessibility•Limited populations•Narrow uses

FUTURE?•Easily aggregated•Broad access•National coverage•Many applications

Clinical Care Data

Advantages of EHR

Global sharing of clinical data Electronically connects Investigators globally

Removes technology barriers Resolves coordination issues Manages privacy requirements

Interactive Voice Response Systems (IVRS) : Investigator calls IVRS Computer linked to system generates the number

Electronic Document Management software: Provides version control, audit trails and archiving Enables multiple authors to work on study documents

Managing drug supply is a challenging aspect of drug trials.

Drugs are usually manufactured in batches on demand

Use of software that forecasts drug supply need based

on subject enrollment and tracks drug inventory.

Emerging technology is the use of Radio Frequency Identification (RFID) technologies

The major benefits of using an RFID enabled solution are Removing manual intervention in tracking and

hence, cost reduction in item tracking Automated tracking of patients within site

premises. Take corrective action to immediately prevent

degradation of samples in transit.

Pharmacovigilance

Spontaneous reportingAERS, VAERS (physician, consumer reporting)CIOMS, ICH safety reporting requirements

Automatic (Computerized) SurveillanceFor reporting drug interactions and laboratory-

based changes

Electronic Signatures

To review and approve content electronic signature is the best way to achieve the goal.

Figure: Indicates an object with multiple versions, of which the sixth version has been signed.

CLINICAL DECISION SUPPORT SYSTEMS

Clinical decision support system will help to facilitate decisions about Risk Diagnosis Therapy, and Follow-up in patient care.

It will cost-effectively address patient’s conditions and preferences, clinician’s workflow, and technical challenges.

COMPONENTS OF CDSS

MONITORING AND CONTROL SYSTEMS

Functions Selectively monitor clinical data continuously Test data against predefined criteria to send alerts

RISK OR OUTCOME PREDICTION SYSTEMS

Functions Perform classification and prediction of outcome or

risk with respect to specific outcome measures, e.g. length of stay, death, complications.

Support risk analysis and risk management

CLINICAL DIAGNOSTIC & TREATMENT SYSTEMS

Functions Recommend diagnosis and treatment planning Detect adverse or specific events

PROTOCOL-BASED DECISION SYSTEMS

Functions Create, maintain, and access to disease

management and best practice guidelines from different information sources

Programs for • real-time patient-specific management advice• automated recommendations, reminders and

alerts Support outcomes analysis and outcomes

management

IT VALIDATION GOALS

Management controlControlled GCP workprocesses usingcomputerized systems

System reliabilityConsistent, intendedperformance ofcomputerised systems

Data integritySecure, accurate, andattributable GCP e-data

Auditable qualityDocumented evidence for control and quality of e-data and e-system

e

EMEA and FDA currently requires that data be submitted in SAS transport files

International Conference on Harmonization (ICH) has defined a standard XML-based (eXtensible Markup Language) electronic submission document, the Electronic Common Technical Document (eCTD).

FDA governs electronic systems used in clinical trials through the regulation Title 21 CFR Part 11

Clinical Data Interchange Standards Consortium

(CDISC)

• Established in 1997.

• Help in developing a common interchange standard for clinical data.

• Collaboration to produce functional standard data models facilitating data interchange between industry stakeholders.

Standards

Supports end-to-end data flow within trials i.e. from source document to regulatory submission

Active collaboration with FDA and analogous regulatory organizations in Europe & Japan

Develops a common interchange standard for clinical data which is accomplished through the development of meta-data models like ODM - Operational Data Model SDM - Submissions Data Model RIM - Reference Information Model ADaM - Analysis Dataset Model

CDISC vs ICH CDISC vs ICH

ICH – working toward global submission ICH – working toward global submission standardsstandards

CDISC – working on standardization of CDISC – working on standardization of submissions at the data levelsubmissions at the data level

Reduction in data errors and data queries as the electronic systems can check for data errors at the time of entry.

Researchers will have quicker access to trial data, since they do not have to wait for paper CRFs or other data to be mailed or posted.

Reduction in the costs of running a clinical trial.

Quicker data entry lead to shorter duration of clinical trials.

Reduced workload and travel costs for site monitors.

Research subjects prefer entering data electronically compared to writing on paper forms.

Investigators and their staff need to be trained.

Systems must provide user authentication, encryption, firewalls, and protection against viruses and malicious attacks.

System performance and reliability are essential to prevent delays and to guarantee that data is transferred accurately and completely to the sponsor.

Require 24-hour Helpdesk support.

Can be expensive, which can be a challenge for small organizations conducting clinical trials.

Lack of agreed-upon standards for sharing of information contained in the EHR, unable to exchange information, which means that data cannot be aggregated

Subjects data confidentiality and privacy

Information must be accessible to clinical research staff in an accurate and up-to-date form

Thus, the Clinical Research Industry, especially the Contract Research Organizations, can be immensely benefited by the Information Technology, and in turn contribute to the society by bringing new drugs and devices into the market with a faster pace, and more effectively.

IT helps the CRO throughout the phases of a trial and even after that!

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