presented by -sandesh mhatre -sanjeev yadav -sarvajnya tattu -shantanu patil -shweta sawant msc. cr...
TRANSCRIPT
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
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.
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.
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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