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 challenges Need for greater access to capital Inability to provide evidence of return on investment Technical challenges Complex and lengthy implementation processes Lack of uniform standards Reluctance towards integrating and incorporating changes to business processes Cultural challenges Lack of leadership support from the public and private sectors Resistance by health care providers
A way of life, and a mark of civilized society We outsource everything Products Services
C LINICAL T RIALS The Way We Make Progress Against Disease
C ONTRACT R ESEARCH O RGANIZATION (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 1. Electronic Data Capture (EDC): Internet based Investigators enter clinical data into data-entry screens Hardware Characteristics: 1.Web enabled, wired or wireless 2.Transfer devices: PDA for patient diaries, etc. 3.Servers 4.Communication protocols TCP/IP, etc.
Software Characteristics: 1.Operating systems Linux, Windows, etc 2.Front end (Graphical User Interface) HTML, JAVA, C+ etc. 3.Backend database Flat, SQL, XML, etc.
2. Direct Data Capture (DDC): Lab test data and ECG results are electronically transmitted from lab to sponsors 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 (E LECTRONIC H EALTH R ECORDS ) 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 benets 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 reporting AERS, VAERS (physician, consumer reporting) CIOMS, ICH safety reporting requirements Automatic (Computerized) Surveillance For 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.
C LINICAL D ECISION S UPPORT S YSTEMS Clinical decision support system will help to facilitate decisions about Risk Diagnosis Therapy, and Follow-up in patient care. It will cost-effectively address patients conditions and preferences, clinicians 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 control Controlled GCP work processes using computerized systems System reliability Consistent, intended performance of computerised systems Data integrity Secure, accurate, and attributable GCP e-data Auditable quality Documented 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 Help in developing a common interchange standard for clinical data. Collaboration to produce functional standard data models facilitating data interchange between industry stakeholders. Standard s
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 ICH – working toward global submission standards ICH – working toward global submission standards CDISC – working on standardization of submissions at the data level CDISC – working on standardization of submissions 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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