eClinical - Computerized Systems Transforming Clinical Research (NS1450X
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I am guest lecturer (paid) at the Boston College William F. Connell School of Nursing (more information at http://www.bc.edu/schools/son/aboutus.html). Three or four times a year I lecture on the application of Computerized Systems in Clinical Research; this is my course deck from 2014.
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eClinical - Computerized Systems Transforming Clinical Research (NS1450X
- 1. Computerized Systems in Clinical Research (NS1450X) eClinical - Computerized Systems in Clinical Research (NS1450X) The rapid adoption of computerized systems in the management of clinical trials is quickly changing not only the dynamics of clinical trials but also redefining the roles of individuals working in the field. While the focus of a clinical trial will always ultimately be on the safety of the patients, eClinical applications now impact everything from case report form collection, to how often sites are monitored, to communication with the patients. This course focuses on understanding how sponsors, contract research organizations, hospitals, universities, clinical investigators and you are being impacted by the movement to eClinical applications. While the instructor will be showing various computer applications as part of the course, students will not be hands-on, will not need computers nor need to be "tech-savvy". The goal of the course is to exposure you to the eClinical applications that you will most likely work with as a CRA or CRC. Pre/Co-Requisite: Essentials of Initiating Clinical Research (NS14601 or NS14602 or NS14603) 1
- 2. NS1450X Agenda 2 6:00PM 15 Mins Introductions 15 Mins Review of Clinical Trials; all Phases 60 Mins Electronic Data Capture (EDC) Clinical Trial Management Systems (CTMS) 7:30PM Break till 7:45PM 45 Mins Risk Based Monitoring (RBM) 20 Mins Questions and Clarifications 8:50PM Close
- 3. 3 Introductions 1. Your Name 2. Have you taken the Essentials of Initiating Clinical Research course? The Healthcare Statistics course? 3. Working in the Clinical Trial Industry now? 4. What would you like to learn from this course?
- 4. 4 Introductions 1. Your Name – Judson Chase 2. Have you taken the Essentials of Initiating Clinical Research course? The Healthcare Statistics course? – About six years ago 3. Working in the Clinical Trial Industry now? – Indirectly 4. What would you like to learn from this course? – Comfort with the “tools” of clinical research
- 5. 5 Judson Chase - clinical trial experience • Abbott Nutrition • AbioMed • AmeriPath • AmerisourceBergen • Amgen • Apex International • Astellas Pharma • AstraZeneca • Bausch and Lomb • Bayer • Baxter Healthcare • Biogen Idec • BioMarin • Biomet • Boehringer-Ingelheim • BostonScientific • Bristol-Myers Squibb • Celgene • Cochlear • Covance • Covidien • CR Bard • CSL Behring • Kyphon • Lifeline • Lifescan (J & J) • MEDRAD MDS Pharma • Medimedia • Medpace • Medtronic • Merck • Millennium Pharma • Nestle • Novartis • Novo Nordisk • Novotech • NxStage Medical • Paratek • Pfizer • PharmaNet • Phillips Healthcare • PRA International • Purdue Pharma • Quark Pharma • Quest Diagnostics • RadPharm • Daiichi Sankyo • deCODE Genetics • ELAN • Eli Lilly • eMed • Galderma • GE Healthcare • Genzyme • Genzyme Genetics • Gilead • Greatbatch • Grünenthal • Hill-Rom • Hologic • ICON • Idenix • ImClone • Infinity Pharma • Ingenix • Invacare • Johnson & Johnson • Kaiser Permanente • KCI • Regeneron • Roche Diagnostics • Salix Pharma • Salter Labs • Sanofi • Schering-Plough • Sepracor • Simpirica Spine • St. Jude Medical • St. Michaels Hospital • Stryker Endo • Stryker Neuro • Stryker Ortho • Sunovion • Trident Clinical Research • Tyco Healthcare • Ultradent • United Therapeutics • University of Toronto • Vertex • Warner Chilcott • Zimmer • Zoll Medical
- 6. 6 Introductions 1. Your Name 2. Have you taken the Essentials of Initiating Clinical Research course? The Healthcare Statistics course? 3. Working in the Clinical Trial Industry now? 4. What would you like to learn from this course?
- 7. NS1450X Agenda 7 6:00PM 15 Mins Introductions 15 Mins Review of Clinical Trials; all Phases 60 Mins Electronic Data Capture (EDC) Clinical Trial Management Systems (CTMS) 7:30PM Break till 7:45PM 45 Mins Risk Based Monitoring (RBM) 20 Mins Questions and Clarifications 8:50PM Close
- 8. Computerized Systems in Clinical Research NS1450X March 20, 2013 - http://www.clinipace.com/the-dcro-streamlining-16- databases-into-one-single-platform
- 9. Computerized Systems in Clinical Research NS1450X
- 10. Why do Sponsors run Clinical Trials? • To assist in the advancement of medical science • Drug and Medical Device makers need to be sure that a drug or medical device is safe • Drug and Medical Device makers need to determine whether a Drug or Medical Device is effective at treating a certain condition • For the Life Sciences industry to make a profit 10 To disprove the null hypothesis via data
- 12. Phase I Clinical Trials • Initial introduction of an investigational drug into humans, generally using healthy volunteers * • Goal : Assess drug safety and dosage in humans • Studies evaluate absorption, distribution, metabolism and elimination (ADME) of the drug, side effects, and determine maximum tolerated doses (MTD) • Few subjects (20 – 80) 12 * Although Phase I studies in most therapeutic areas consist of healthy patients, Phase I studies in oncology consist of patients with active disease.
- 13. Phase I Clinical Trials 13 *MTD (maximum tolerated dose ) --the highest dose for which no more than 1 of the 6 treated patients exhibits DLT (dose-limiting toxicity )
- 14. Phase I Clinical Trials - LabPas (Oracle) 14
- 15. Phase II Clinical Trials • Determines common short-term side effects and risks • Goal : Assess efficacy and safety and further evaluate the proposed dosage from Phase humans • Conducted in the target population • Determines the best dose for the target population and how often it should be given • Few subjects (100 – 300) 15
- 16. Phase III Clinical Trials • Definitive efficacy studies for regulatory submission and approval • Goal : Gather pivotal efficacy / safety information needed to evaluate the overall risk-benefit ration of the drug in the target population • Usually conducted in hundreds or even thousands of subjects at multiple sites • Two to three years+ in duration 16
- 17. Phase IV Clinical Trials • Studies can continue after approval application is submitted • Goal : After approval, continue to assess long-term safety • May be required as part of Regulatory Agency approval • Paper Patient Dairies and ePRO (electronic patient reported outcome) 17
- 18. “Virtual” Clinical Trials 18 • Pfizer and Mytrus • From home via Internet, mobile phone and snail mail • Overly complex enrollment process hampered recruitment • Designed for US; consideration to modify for European regulators’ needs • Search YouTube for “Mytrus At-Home Online Knee Osteoarthritis Clinical Trial” http://www.youtube.com/watch?v=0fEx5V45zp4
- 19. HEOR Clinical Trials • Health Economics analyses • Outcome Research analyses • Not empirical in nature (i.e., no Protocol involved) • Could be just data from past trials • Could be subjective data (i.e., Truven or Micromedex) • Think “dollars”; not just “data” 19
- 20. NS1450X Agenda 20 6:00PM 15 Mins Introductions 15 Mins Review of Clinical Trials; all Phases 60 Mins Electronic Data Capture (EDC) Clinical Trial Management Systems (CTMS) 7:30PM Break till 7:45PM 45 Mins Risk Based Monitoring (RBM) 20 Mins Questions and Clarifications 8:50PM Close
- 21. 21 Paper Case Report Forms vs. EDC
- 23. 23 Overview of Paper CRF Process Flow Medical Term Coding by sponsor CDM personnel Database Soft Lock by sponsor CDM personnel Check of validity of data by CRA during monitoring visit Double data entry by sponsor CDM personnel CRF Collection by CRA Quality Control Checks by sponsor CDM personnel Load External Data by sponsor CDM personnel Database Hard Lock by sponsor CDM personnel Monitoring Visit Query Resolution by CRA and investigator Query Generation by sponsor CDM personnel Collection of subject data in source notes & paper CRF by investigator $$$ $$$ $$$
- 24. EDC Is Now Used For Over Half Of All Phase II Trials and Almost All Of Phase III Trials Source: Health Industry Insights, “Business Strategy: U.S. Electronic Data Capture 2008–2014 Spending Forecast and Analysis”, 2010 U.S. Electronic Data Capture Adoption by Segment, 2008-2014
- 25. 25 Overview of e-CRF (EDC) Process Flow Medical Term Coding by sponsor CDM personnel Database Soft Lock by sponsor CDM personnel Collection of subject data in source notes by site personnel Online direct transfer into database by site personnel Completion of eCRF by site personnel Quality Control Checks by sponsor CDM personnel Load External Data by sponsor CDM personnel Database Hard Lock By sponsor CDM personnel Query resolution by investigator Query Generation by sponsor CDM personnel
- 26. Medidata Rave (EDC) screen capture 26
- 27. Oracle RDC (EDC) screen capture 27
- 28. REDCap (EDC) screen capture 28
- 30. Digital Medicines: Proteus Digital Health Trademark Proteus Biomedical 30
- 31. Digital Bio-Medical Devices: Google Inc Trademark Proteus Biomedical 31
- 32. Digital Bio-Medical Devices: Fit bands Trademark Proteus Biomedical 32
- 33. 33
- 38. CTMS demonstration 38 Break at 7:30PM
- 39. NS1450X Agenda 39 6:00PM 15 Mins Introductions 15 Mins Review of Clinical Trials; all Phases 60 Mins Electronic Data Capture (EDC) Clinical Trial Management Systems (CTMS) 7:30PM Break till 7:45PM 45 Mins Risk Based Monitoring (RBM) 20 Mins Questions and Clarifications 8:50PM Close
- 40. NS1450X Agenda 40 6:00PM 15 Mins Introductions 15 Mins Review of Clinical Trials; all Phases 60 Mins Electronic Data Capture (EDC) Clinical Trial Management Systems (CTMS) 7:30PM Break till 7:45PM 45 Mins Risk Based Monitoring (RBM) 20 Mins Questions and Clarifications 8:50PM Close
- 41. Essentials of Initiating Clinical Research NS1460X
- 42. 42 Risk Based Monitoring (RBM)
- 43. 43 Math and Clinical Trials
- 44. RBM. . . what is Risk Based Monitoring? Risk Based Monitoring (RBM) Disciplines RBM KRI Dashboards Adaptive SMV & SDVEnrichment Strategies Fraud DetectionEnrollment Monitoring QMS / GCP Compliance Site Initiation Enrollment Prediction
- 45. 45 RBM. . . what is Risk Based Monitoring?
- 46. RBM. . . what is Risk Based Monitoring? 30May2013
- 47. 47 RBM Applied to Clinical Trials For Centralized Monitoring, Project Management, CRA’s Which of my sites are most “problematic”? Which sites should I visit next week? How long should I plan to spend at each site?
- 49. NS1450X Agenda 49 6:00PM 15 Mins Introductions 15 Mins Review of Clinical Trials; all Phases 60 Mins Electronic Data Capture (EDC) Clinical Trial Management Systems (CTMS) 7:30PM Break till 7:45PM 45 Mins Risk Based Monitoring (RBM) 20 Mins Questions and Clarifications 8:50PM Close
- 50. Computerized Systems in Clinical Research (NS1450X) eClinical - Computerized Systems in Clinical Research (NS1450X) The rapid adoption of computerized systems in the management of clinical trials is quickly changing not only the dynamics of clinical trials but also redefining the roles of individuals working in the field. While the focus of a clinical trial will always ultimately be on the safety of the patients, eClinical applications now impact everything from case report form collection, to how often sites are monitored, to communication with the patients. This course focuses on understanding how sponsors, contract research organizations, hospitals, universities, clinical investigators and you are being impacted by the movement to eClinical applications. While the instructor will be showing various computer applications as part of the course, students will not be hands-on, will not need computers nor need to be "tech-savvy". The goal of the course is to exposure you to the eClinical applications that you will most likely work with as a CRA or CRC. Pre/Co-Requisite: Essentials of Initiating Clinical Research (NS14601 or NS14602 or NS14603) 50 APPENDIX
- 51. “What’s Next?” •Applications aware of your location • Slides • Electronic Informed Consent • Slides • Virtual Trials • http://www.mytrus.com • http://www.mytrus.com/participate 51
- 58. CTMS • Contacts and Site information • Calendar • Site visit follow-up actions • Trip reports with data consolidated from site visit and Workflow approval • Site Visit Findings flow into Site Visit Report Social Media • Blogs – “Where is it safe to eat around here?” Device Integrations • GPS/Location based tracking of activities for compliance • Site contacts listing and scheduling meetings via calendar apps • Integration with messaging apps CRA EDC Social Media CTMSAlerts Safety Applications aware of your location
- 59. Applications aware of your location
- 60. 60
- 61. 61
- 65. LinkedIn