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How should subjects be routinely managed to prevent study withdrawal?

Please Be Sure That You Have Your Audience Response Keypad With You This Morning. You Will Need It During This Session. 10.

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How should subjects be routinely managed to prevent study withdrawal?

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Presentation Transcript

  1. Please Be Sure That You Have Your Audience Response Keypad With You This Morning. You Will Need It During This Session

  2. 10 Clinical trials principles dictate that complete ascertainment of the primary endpoint gives the optimal chance of proving the objective. In the IMPROVE IT Trial, the primary endpoint is a composite of CV death, MI, UA, Stroke, and Revasc. If the subject withdraws from the trial and all visits, what happens in the ITT analysis? • The subject is removed from the database and replaced with another subject who completed the entire trial. • The subject is only analyzed in the safety analyses. • The subject is analyzed up to the time of study withdrawal. • The subject’s data present at the time of study withdrawal is used for the remaining months of the trial in the analysis.

  3. 10 How should subjects be routinely managed to prevent study withdrawal? • Schedule appointment and send reminder to the subject within 7 days. • Schedule appointment at the end of the follow-up window to maximize the use of the study drug in the bottles (avoid waste). • Schedule appointment and notify subject of date and time within 3 weeks of appointment. • Maintain close contact with subject in between visits, schedule appointment when convenient for subject (be flexible), call to remind.

  4. 10 When is the best time to let the monitor know of a subject who is not available for follow-up? • At the end of the trial • After the subject has missed 1 visit • After the subject has missed 2 visits (8-12 months) • After the Research Team has performed all the suggested steps on the “Lost to Follow Up Checklist” form

  5. 10 If a subject expresses concern that she will not be available for the appointment within the time window and therefore wishes to “finish” their participation in the trial, what should the RC do? • Communicate to the subject the need to stay on study drug. Make arrangements for the subject to see another MD in the practice. • Agree that the subject has participated for most of the study and it would be OK to finish. Continue phone contact for endpoints. • Skip that appointment and call the subject when (s)he is available.

  6. 10 What is the goal of “Getting with the Guidelines – (GWTG)”? • To get MDs to prescribe ASA to CAD patients. • To reduce bleeding rates to an acceptable level. • To reduce death/disability of CHD/stroke by 25% by 2010. • To illustrate to insurance companies that the optimal treatment is being given to the patient.

  7. 10 The “GWTG” is based on: • The MD’s personal experience. • Evidence based medicine. • The type of treatment options that are available: (PCI, CABG, nuclear equipment). • Individual hospital survey.

  8. 10 Which one of the following is NOT a “GWTG” Performance Measure for Cardiovascular Disease? • Perform PCI before hospital discharge • Smoking Cessation Counseling • ACE-I / ARB for LVSD on discharge • Lipid lowering therapy on discharge

  9. 10 What characteristics are associated with statin use at hospital discharge? • Renal insufficiency • Age >60 yrs • Absence of diabetes • Measuring LDL in hospital

  10. 10 In following your IMPROVE-IT subjects do you discuss: • Cessation of smoking • Healthy food choices • Increase physical activity • All of the above

  11. 10 If a subject complains of persistent but mild headaches and wishes to come off study drug, what should the RC do? • Agree and let patient know that it is possibly due to the study drug • Acquire more information from patient, review con meds, and discuss w/PI the most likely reason for headaches • Inform the patient there is nothing that can be done by that the patient should stay on study drug • Give Tylenol to the patient

  12. 10 The PI is very busy with his/her private practice and does not have time to commit to IMPROVE-IT. What steps should the RC undertake? • Perform trial tasks / responsibilities on his/her own. • Seek support from the TIMI Hotline for questions. • Participate in a meetings with PI to review specific areas where help / support is needed. • Abandon efforts to recruit subjects

  13. Let’s Check the Standings

  14. Please Turn In Your Keypad, Holder and Lanyard IMMEDIATELY Following This Session in the Back of the Room.

  15. Participant Scores

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