dr. apoorvab.m , dr. kiranl.j , mr. chethan kumar s department … · 2017-02-02 · data...
TRANSCRIPT
![Page 1: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/1.jpg)
Dr. Apoorva B.M1, Dr. Kiran L.J2, Mr. Chethan Kumar S3
Department Of Pharmacology
S.S Institute of Medical Sciences and Research Centre
Davangere
![Page 2: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/2.jpg)
INTRODUCTION
![Page 3: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/3.jpg)
Contd..� Clinical Trials software reduces administrative
burdens and workloads by consolidating informationin a single location that facilitates collaborationbetween all the research personnel.
� Benefits:
� Accurate, legible, original and authentic
� Complete, consistent and enduring
� Available when needed
![Page 4: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/4.jpg)
How it helps?
� Investigators and Co-ordinators
�Easily create protocols
�Track enrolment and progress
�Communication with research personnel’s�Communication with research personnel’s
�Track financial activity
� Administrators
�Report on clinical trials for multiple departments
�Verify compliance with institutional requirements
�Customise the trial environment
![Page 5: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/5.jpg)
Softwares used in Clinical research are broadly divided into different domains
� Trial management
� CDM
� Pharmacovigilance � Pharmacovigilance
![Page 6: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/6.jpg)
Clinical Trial Management System
� Software system used to manage clinicaltrials in clinical research.
� Maintains and manages planning, performing andreporting functions.
� Patient management and recruitment, investigatormanagement at the study site and CRO site.
![Page 7: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/7.jpg)
Softwares for CTMSSOFTWARES FEATURES
Open Clinica Unified interface, Electronicdata capture
RealTime-CTMS Patient recruitment, studytracking, financial accounting,schedulingscheduling
Allergo CTMS Activity and status of trial
Clinical Conductor CTMS Research sites, AMC’s, CRO’s
Bio Clinica CTMS Supports studies of all types
BSI CTMS BSI Business systemsIntegration
![Page 8: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/8.jpg)
Contd..SOFTWARES FEATURES
Ag Clinical Planning and tracking clinical trial activities.
Clinical Trials Management For sponsors and CRO’s to Clinical Trials Management For sponsors and CRO’s to expedite clinical trials
Ques Gen Platform Web-based solution designed specifically for configuring and managing clinical databases
Open Text Clinicals Case report tracking process
![Page 9: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/9.jpg)
Clinical Data Management
� CDM is the process of collection, cleaning, andmanagement of subject data in compliance withregulatory standards.
� Generation of high- quality, reliable, and statisticallysound data from clinical trials.
Objective:
�To provide high quality data for accurate drugevaluation.
![Page 10: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/10.jpg)
Contd..
Processes involved in CDM :
1. Case Report Form (CRF) designing
2. CRF annotation
3. Database designing3. Database designing
4. Data entry
5. Data validation
6. Discrepancy management
7. Medical Coding
8. Data extraction
9. Database locking
![Page 11: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/11.jpg)
Softwares for CDMMost of the CDMS used in pharmaceutical companies are commercial.
Softwares Features
ORACLE CLINICAL Integrated CDM and remote data ORACLE CLINICAL Integrated CDM and remote data capture
CLINTRIAL Provide real time data access and enhanced data quality
MACRO EDC for all trials from phase 1-4
RAVE Flexible, scalable, configurable
E Clinical Suite Simple, fast and affordable for collection of data
![Page 12: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/12.jpg)
Softwares Features
Open Clinica EDC
Open CDMS enable researches to managefull cycle of their clinical full cycle of their clinical research
Trial DB EDC
Phosco EDC
![Page 13: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/13.jpg)
Medical Coding
� Medical coding helps in identification and propercoding of medical terminologies related to the trial.
� MedDRA - coding of adverse events
� WHO-DDE - coding the medications
� WHO-ART -adverse reactions terminology
� WHO HD – herbal concomitant medications
� WHO DDC – translates into WHO DDE
![Page 14: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/14.jpg)
PHARMACOVIGILANCE
Pharmacovigilance is a safety database
� Used for Adverse Event Reporting
� Adverse Drug Reaction Data Management
� Regulatory reporting of ICSR (Individual Case Safety Reporting)
� Signal detection in Adverse Drug Reactions.
![Page 15: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/15.jpg)
Softwares for Pharmacovigilance
ARIS g
� Leading Pharmacovigilance and clinical safety system
�Manage adverse event reporting and adverse reaction
Applicable for vaccines, biologics, devices�Applicable for vaccines, biologics, devices
�Flexible and scalable
�Can be used by small companies and large organisations
![Page 16: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/16.jpg)
PvNET
� Supports to segregate data entry, scientific assessment
� Extensive data validation and cross validation checks
� MedRA version management
Covers full spectrum of developing good safety report� Covers full spectrum of developing good safety report
ARGUS
� Manage data from multiple sources
� Access flexible drug safety databases
![Page 17: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/17.jpg)
Softwares Contd..Softwares Features
Oracle AERS Reporting and analysis of serious adverse events of all medicinal products
PV Works Collect and report safety data PV Works Collect and report safety data to meet all common international regulations
Clintrace Clinical reearch, post approval marketing, drug surviellance
Pcv manager Based on E2b and medDRAindustry data standards
![Page 18: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/18.jpg)
Post Marketing SurveillanceTOOLS:
� VigiFlow –Collection and analysis of individual casesafety reports
� VigiLyze -Facilitates analysis of vigibase data� VigiLyze -Facilitates analysis of vigibase data-Global, National view of an ADR-Monitor international patient safety data
� VigiBase-Information about safety profile of drugs andcompetitive products & optimise queries
� PaniFlow- Monitor ADR during influenza pandemic
![Page 19: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/19.jpg)
Conclusion
� Softwares provide high quality data by reducing andminimising errors according to regulatory standards
� The data generated is of persistent quality and plays a� The data generated is of persistent quality and plays asignificant role in the outcome of the study
� Hence the softwares play important role not only inreducing time , but also helps to improve the dataquality and cost factor in Clinical Research domain.
![Page 20: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/20.jpg)
References� Krishnakutty B, Bellary S, kumar RBN, Moodahadu SL.
Data management in clinical research. Indian J Pharmacol. 2014;44:168-72
� Ottevanger PB, Therasse P, van de Velde C, Bernier J, van � Ottevanger PB, Therasse P, van de Velde C, Bernier J, van Krieken H, Grol R, et al. Quality assurance in clinical trials. Crit Rev Oncol Hematol. 2003;47:213–35.
� Haux R, Knaup P, Leiner F. On educating about medical data management - the other side of the electronic health record. Methods Inf Med. 2007;46:74–9
![Page 21: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/21.jpg)
References contd..� Kuchinke W, Ohmann C, Yang Q, Salas N, Lauritsen J,
Gueyffier F, et al. Heterogeneity prevails: The state of clinical trial data management in Europe - results of a survey of ECRIN centres. Trials. 2010;11:79.
� Francis D, Roberts I, Elbourne DR, Shakur H, Knight RC, Garcia J, Snowdon C,Entwistle VA, McDonald AM, Grant Garcia J, Snowdon C,Entwistle VA, McDonald AM, Grant AM, Campbell MK: Marketing andclinical trials: a case study. Trials 2007, 8:37.
� S Z Rahman & K C Singhal, Problems in pharmacovigilanceof medicinal products of herbal origin and means to minimize them, Uppsala Reports, WHO Collaborating Center for ADR monitoring, Uppsala Monitoring Centre, Sweden, Issue 17 January 2002: 1-4 (Supplement)
![Page 22: Dr. ApoorvaB.M , Dr. KiranL.J , Mr. Chethan Kumar S Department … · 2017-02-02 · Data management in clinical research. Indian J Pharmacol. 2014;44:168-72 Ottevanger PB, Therasse](https://reader034.vdocuments.mx/reader034/viewer/2022043007/5f918a401708f053992ca441/html5/thumbnails/22.jpg)