6 Financial challengesNeed for greater access to capitalInability to provide evidence of return on investmentTechnical challengesComplex and lengthy implementation processesLack of uniform standardsReluctance towards integrating and incorporating changes to business processesCultural challengesLack of leadership support from the public and private sectorsResistance by health care providers
8 A way of life, and a mark of civilized society We outsource everythingProductsServices
9 The Way We Make Progress Against Disease Clinical TrialsThe Way We Make Progress Against Disease
10 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)
11 Reasons for Outsourcing Clinical Trials: Demanding regulatory environmentComplexity of trial design and logisticsNeed for multiethnic populationIncrease in number of patients and duration of follow upLong duration of clinical developmentDelay in recruitmentCost of development
13 Refers to the use of electronic systems for automation of clinical trials Primary electronic processes are used to plan, collect, access, exchange, archive dataReasons for this interest are:Advances in information technologyThe increasing cost of drugDesire to detect drug safety problems sooner.
17 DATA COLLECTION 1. Electronic Data Capture (EDC): Internet based Investigators enter clinical data into data-entry screensHardware Characteristics:Web enabled, wired or wirelessTransfer devices:PDA for patient diaries, etc.3. ServersCommunication protocolsTCP/IP, etc.
18 Software Characteristics: Operating systemsLinux, Windows, etcFront end (Graphical User Interface)HTML, JAVA, C+ etc.3. Backend databaseFlat, SQL, XML, etc.
19 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 theirstudy medicationdosing times andlog of their symptoms.Now, subjects are being asked to directly enter data into computers, portable electronic devices
21 (DBMS)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 dataSoftware such as SPSS ® ’s Clementine, SAS ® Enterprise Miner for Data mining
22 EHR (Electronic Health Records) Electronic Health Records give immediate electronic access to patient- and population-level information by authorized usersEHR improves the quality of Clinical Data, makes it more easily accessible, and more useful for safety, outcomes, and other types of analyses.
23 EHRsTODAYFragmentedLimitedaccessibilitypopulationsNarrow usesFUTURE?Easily aggregatedBroad accessNational coverageMany applicationsClinical Care Data
24 Global sharing of clinical data Advantages of EHRGlobal sharing of clinical dataElectronically connects Investigators globallyRemoves technology barriersResolves coordination issuesManages privacy requirements
25 Interactive Voice Response Systems (IVRS) : Investigator calls IVRSComputer linked to system generates the numberElectronic Document Management software:Provides version control, audit trails and archivingEnables multiple authors to work on study documents
27 Managing drug supply is a challenging aspect of drug trials. Drugs are usually manufactured in batches on demandUse of software that forecasts drug supply need basedon subject enrollment and tracks drug inventory.Emerging technology is the use of Radio Frequency Identification (RFID) technologies
28 The major beneﬁts of using an RFID enabled solution are Removing manual intervention in tracking and hence, cost reduction in item trackingAutomated tracking of patients within site premises.Take corrective action to immediately prevent degradation of samples in transit.
30 PharmacovigilanceSpontaneous reportingAERS, VAERS (physician, consumer reporting)CIOMS, ICH safety reporting requirementsAutomatic (Computerized) SurveillanceFor reporting drug interactions and laboratory-based changesElectronic SignaturesTo review and approve content electronic signature is the best way to achieve the goal.
31 Figure: Indicates an object with multiple versions, of which the sixth version has been signed.
33 Clinical Decision Support Systems Clinical decision support system will help to facilitate decisions aboutRiskDiagnosisTherapy, andFollow-up in patient care.It will cost-effectively address patient’s conditions and preferences, clinician’s workflow, and technical challenges.
35 COMPONENTS OF CDSS MONITORING AND CONTROL SYSTEMS Functions Selectively monitor clinical data continuouslyTest data against predefined criteria to send alertsRISK OR OUTCOME PREDICTION SYSTEMSPerform 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
36 CLINICAL DIAGNOSTIC & TREATMENT SYSTEMS FunctionsRecommend diagnosis and treatment planningDetect adverse or specific eventsPROTOCOL-BASED DECISION SYSTEMSCreate, maintain, and access to disease management and best practice guidelines from different information sourcesPrograms forreal-time patient-specific management adviceautomated recommendations, reminders and alertsSupport outcomes analysis and outcomes management
37 e IT VALIDATION GOALS Management control Controlled GCP work processes usingcomputerized systemsSystem reliabilityConsistent, intendedperformance ofcomputerised systemseData integritySecure, accurate, andattributable GCP e-dataAuditable qualityDocumented evidencefor control and qualityof e-data and e-system
39 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
40 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
41 Supports end-to-end data flow within trials i. e Supports end-to-end data flow within trials i.e. from source document to regulatory submissionActive collaboration with FDA and analogous regulatory organizations in Europe & JapanDevelops a common interchange standard for clinical data which is accomplished through the development of meta- data models likeODM - Operational Data ModelSDM - Submissions Data ModelRIM - Reference Information ModelADaM - Analysis Dataset Model
42 CDISC vs ICH ICH – working toward global submission standards CDISC – working on standardization of submissions at the data levelData Capture Forms are also “generated” by the site (or study participant). During monitoring activities, according to GCP, the sponsor will compare the data capture forms to the source documents to confirm:Capture of all relevant data associated with testing or examination of the participant.Accurate transcription of source data.
44 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.
46 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.
47 Lack of agreed-upon standards for sharing of information contained in the EHR, unable to exchange information, which means that data cannot be aggregatedSubjects data confidentiality and privacyInformation must be accessible to clinical research staff in an accurate and up-to-date form
49 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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