Ivrs

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IVRS and IWRS are the tools used in clinical research for various functions. IVRS ppt is powered by www.crtutor.com

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Ivrs

  1. 1. IVRS /IWRS www.crtutor.com Gaurav Sharma
  2. 2. IVRS <ul><li>INTERACTIVE VOICE RESPONSE SYSTEM </li></ul><ul><li>www.crtutor.com </li></ul>Gaurav Sharma
  3. 3. IWRS <ul><li>INTERACTIVE WEB RESPONSE SYSTEM </li></ul><ul><li>www.crtutor.com </li></ul>Gaurav Sharma
  4. 4. <ul><li>PROCESSES ARE CONTROLLED BY A CENTRAL COMPUTER </li></ul><ul><li>ACCESSED via TELEPHONE (Interactive Voice Response, IVR) and WEB (Interactive Web Response,IWR) INTERFACES. </li></ul><ul><li>VERY USEFUL IN GLOBAL TRIALS </li></ul>Gaurav Sharma
  5. 5. USES <ul><li>REGISTER NEW PATIENTS </li></ul><ul><li>RANDOMISE PATIENTS </li></ul><ul><li>OBTAIN DOUBLE BLIND MEDICATION </li></ul><ul><li>FOR RANDOMISED PATIENTS </li></ul><ul><li>RECORD PATIENT SPECIFIC VISIT INFORMATION </li></ul><ul><li>ORDER OPEN LABEL OR RUN IN MEDICATION </li></ul><ul><li>BLINDING </li></ul>Gaurav Sharma
  6. 6. Uses contd… <ul><li>TO UNBLIND PATIENTS IN A MEDICAL EMERGENCY </li></ul><ul><li>ORDER DUPLICATE REGISTRATION OR MEDICAL DISPENSING FAXES </li></ul>Gaurav Sharma
  7. 7. Automated Supply Chain Management <ul><li>Automated site and depot medication inventory control </li></ul><ul><li>Management of complex dispensing protocols, e.g.titration studies </li></ul><ul><li>Dose calculation </li></ul><ul><li>Help to ensure patient compliance </li></ul>Gaurav Sharma
  8. 8. Patient Recruitment Technology <ul><li>Is your next patient a phone call away? </li></ul><ul><li>Study-specific pre-qualification IVR interview </li></ul><ul><li>No requirement for the services of a call center </li></ul><ul><li>Complete multinational / multilingual capabilities </li></ul><ul><li>Compliant with Data Protection regulations </li></ul><ul><li>Simple to add new countries and centers mid-study </li></ul><ul><li>Suitable for many patient populations and indications </li></ul>Gaurav Sharma
  9. 9. Patient Recruitment Technology <ul><li>ADVANTAGES: </li></ul><ul><li>Reduces the recruitment period </li></ul><ul><li>Cost-effective solution </li></ul><ul><li>Simple to administer over multinational / multilingual studies </li></ul><ul><li>Increases site efficiency by increasing the throughput of eligible patients at site </li></ul><ul><li>Lowers the screening failure rate and the associated cost of screening failures </li></ul><ul><li>Real-time reporting </li></ul>Gaurav Sharma
  10. 10. Randomization and Medication Management <ul><li>Do you know where your supplies need to be? </li></ul><ul><li>Automated Supply Chain Management </li></ul>Gaurav Sharma
  11. 11. Randomization <ul><li>Definition: </li></ul><ul><li>The random allocation of treatments to patients or subjects in order of their enrollment into the study (per site), in order to produce comparable groups. </li></ul>Gaurav Sharma
  12. 12. Randomization <ul><li>Types </li></ul><ul><ul><li>Simple – by site </li></ul></ul><ul><ul><li>Blocks – for the whole study & blocks allocated to sites </li></ul></ul><ul><ul><li>Stratification </li></ul></ul><ul><li>Block : </li></ul><ul><li>A sequential set of randomization that consist of an equal number the investigational product and the comparator </li></ul><ul><li>If block size = 6, Treatment A and Treatment B used in study </li></ul><ul><li>Randomization numbers 1 to 6 are allocated - 3 Treatment A, 3 Treatment B </li></ul>Gaurav Sharma
  13. 13. Randomization <ul><li>Stratification </li></ul><ul><ul><li>used when a marked variation expected in the study population with respect to response to medication related to age, sex, severity of disease etc. </li></ul></ul>Gaurav Sharma Informed Consent Signed Stratification > 50 years old < 50 years old Active Active Placebo Placebo Randomisation Randomisation
  14. 14. Blinding <ul><li>Types of Blinds </li></ul><ul><li>Open label </li></ul><ul><ul><li>Both Investigator, patient aware of the treatment </li></ul></ul><ul><li>Single blind </li></ul><ul><ul><li>Only one party blinded </li></ul></ul><ul><li>Double blind </li></ul><ul><ul><li>Both parties are blinded </li></ul></ul><ul><li>Observer blind </li></ul><ul><ul><li>Person making assessments is blinded </li></ul></ul>Gaurav Sharma
  15. 15. Blinding <ul><li>Advantages of Double Blinding </li></ul><ul><ul><li>Investigator cannot choose treatment for a patient </li></ul></ul><ul><ul><li>Opinions of patient and investigator do not influence outcome </li></ul></ul><ul><ul><li>Additional care will not be different </li></ul></ul><ul><ul><li>Endpoint not influenced by treatment knowledge </li></ul></ul>Gaurav Sharma
  16. 16. Methods of Blinding Gaurav Sharma Matching Double Dummy Treatment A Treatment B Treatment A Treatment B Active Placebo Active Placebo
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  19. 19. Electronic Patient Reported Outcomes <ul><li>Have you heard from your patients lately? </li></ul><ul><li>Real-Time Data Capture </li></ul><ul><li>Patient reported outcomes data are becoming increasingly important in clinical trials and regulatory submissions. </li></ul><ul><li>In some therapy areas these represent primary efficacy data, and in many may influence drug labelling. </li></ul>Gaurav Sharma
  20. 20. Electronic Patient Reported Outcomes <ul><li>These data include symptom diaries, objective self-report measurements, health service utilization, quality of life and treatment satisfaction assessments. </li></ul><ul><li>Many studies have identified concerns over the use of paper diaries and questionnaires, criticizing their limitations on data quality and integrity. </li></ul>Gaurav Sharma
  21. 21. Electronic Patient Reported Outcomes <ul><li>IVR represents a simple alternative to paper that offers significant improvements in data quality. </li></ul>Gaurav Sharma
  22. 22. Diary Compliance Assurance <ul><li>Because subject data are captured directly onto IVRS robust and secure central database, systems can identify all subjects that have missed, or may be at risk of missing, a scheduled diary entry. </li></ul><ul><li>These patients may need additional encouragement to maintain the study diary entry schedule. </li></ul>Gaurav Sharma
  23. 23. Diary Compliance Assurance <ul><li>Methods to enhance patient diary compliance: </li></ul><ul><li>Investigational site contact 1. Automated fax or email reports are dispatched to study site personnel identifying those subjects requiring contact. </li></ul><ul><li>2. Timely contact by site staff is successful in providing patient encouragement and enhancing diary compliance. </li></ul>Gaurav Sharma
  24. 24. Diary Compliance Assurance <ul><li>Trained local-language outbound operators provide reminder calls to consenting subjects identified at risk of missing a diary entry. </li></ul><ul><li>This may be especially valuable in therapy areas where patient motivation is particularly low, or where the required compliance is very high. </li></ul>Gaurav Sharma
  25. 25. Unblinding <ul><li>When </li></ul><ul><ul><li>On study completion </li></ul></ul><ul><ul><li>To manage a medical emergency </li></ul></ul><ul><li>Method </li></ul><ul><ul><li>Use of coded envelopes </li></ul></ul><ul><ul><li>24-hour phone line </li></ul></ul>Gaurav Sharma
  26. 26. Unblinding <ul><li>Requirements of unblinding process </li></ul><ul><ul><li>provides only individual patient treatment code </li></ul></ul><ul><ul><li>Unblinding detectable </li></ul></ul><ul><ul><li>Non-concealable or seal-able </li></ul></ul><ul><ul><li>Easy identification </li></ul></ul><ul><ul><li>Quick </li></ul></ul>Gaurav Sharma
  27. 27. Gaurav Sharma
  28. 28. <ul><li>After the site is selected, the site is registered into the global IVR system chain – i.e., a specific number/code is allotted to the study at the particular site. This is further explained to all the study personnel during the initiation meeting. Then when you log on to the IVR/IWR system you will be able to get access to the system. </li></ul>Gaurav Sharma
  29. 29. PROCEDURE <ul><li>COMPLETE THE WORKSHEET BEFORE CALLING </li></ul><ul><li>DIAL THE APPROPRIATE TELEPHONE NUMBER OF THE COUNTRY </li></ul><ul><li>YOU WILL GET A WELCOME MESSAGE </li></ul><ul><li>NEXT YOU WILL BE ASKED TO ENTER THE PROTOCOL NUMBER,THE COMPOUND NUMBER, CENTER NUMBER </li></ul>Gaurav Sharma
  30. 30. Procedure contd…. <ul><li>ONCE YOU HAVE ENTERED THE INFORMATION YOU WILL BE TAKEN TO THE STUDY OPTIONS MENU </li></ul><ul><li>THIS WILL BE TAILORED TO INDIVIDUAL STUDY REQUIREMENTS </li></ul><ul><li>LISTEN CAREFULLY AND RESPOND TO THE PRE-RECORDED MESSAGES </li></ul><ul><li>USE YOUR WORKSHEET TO GUIDE YOU THROUGH THE TELEPHONE CALL </li></ul>Gaurav Sharma
  31. 31. <ul><li>. </li></ul>Gaurav Sharma
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  38. 38. IVRS+ EDC <ul><li>Automated real-time data exchange between EDC and ClinPhone systems </li></ul><ul><li>Randomization and dispensing data shared by both systems </li></ul><ul><li>Protocol-specific integration touch points </li></ul><ul><li>Data may originate in either system </li></ul><ul><li>IVR patient diary data automatically populates eCRF </li></ul><ul><li>Eliminates need for re-keying data and discrepancy resolution </li></ul>Gaurav Sharma
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  40. 40. Interactive Web Response <ul><li>Wouldn’t two routes into a study be better than one? </li></ul><ul><li>Both interfaces interact simultaneously with the same computer engine and databases that direct and record study processes. </li></ul><ul><li>This means that study sites can choose to utilize the most convenient and appropriate interface for a particular study. </li></ul><ul><li>System audit trail, backup and support is independent of the mode of system access. </li></ul>Gaurav Sharma

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