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How Many Electronic CRF How Many Electronic CRF Trials Have You Done?Trials Have You Done?

A. B. C.

20%

42%38%

A.A. Only OneOnly One

B.B. 2-32-3

C.C. More than 3More than 3

What Other EDC Systems What Other EDC Systems Have You Used?Have You Used?

A. B. C. D. E. F. G.

7% 7%

15%

38%

17%

10%

7%

A.A. DatatrakDatatrak

B.B. e-trialse-trials

C.C. MedidataMedidata

D.D. Datatrak and e-trialsDatatrak and e-trials

E.E. e-trials and Medidatae-trials and Medidata

F.F. All threeAll three

G.G. None of the AboveNone of the Above

Which is the Easiest / Which is the Easiest / Preferred System?Preferred System?

A. B. C. D. E. F.

2% 3%

27%

0%

9%

59%A.A. DatatrakDatatrak

B.B. e-trialse-trials

C.C. InFormInForm

D.D. MedidataMedidata

E.E. Other SystemOther System

F.F. No PreferenceNo Preference

Which is the Most Difficult Which is the Most Difficult System To use?System To use?

A. B. C. D. E.

22%

8%

60%

8%3%

A.A. DatatrakDatatrak

B.B. e-trialse-trials

C.C. InFormInForm

D.D. MedidataMedidata

E.E. Other SystemOther System

Do You Prefer an Electronic Do You Prefer an Electronic CRF of Paper CRF?CRF of Paper CRF?

A. B.

14%

86%A.A. Electronic CRFElectronic CRF

B.B. Paper CRFPaper CRF

Clinical trials principles dictate that complete Clinical trials principles dictate that complete ascertainment of the primary endpoint gives the ascertainment of the primary endpoint gives the optimal chance of proving the objective. In the optimal chance of proving the objective. In the IMPROVE IT Trial, the primary endpoint is a IMPROVE IT Trial, the primary endpoint is a composite of CV death, MI, UA, Stroke, and Revasc. composite of CV death, MI, UA, Stroke, and Revasc. If the subject withdraws from the trial and all visits, If the subject withdraws from the trial and all visits, what happens in the ITT analysis?what happens in the ITT analysis?

A. B. C. D.

5%

31%

39%

25%

A.A. The subject is removed from The subject is removed from the database and replaced with the database and replaced with another subject who another subject who completed the entire trial.completed the entire trial.

B.B. The subject is only analyzed in The subject is only analyzed in the safety analyses.the safety analyses.

C.C. The subject is analyzed up to The subject is analyzed up to the time of study withdrawal.the time of study withdrawal.

D.D. The subject’s data present at The subject’s data present at the time of study withdrawal is the time of study withdrawal is used for the remaining months used for the remaining months of the trial in the analysis.of the trial in the analysis.

How should subjects be How should subjects be routinely managed to routinely managed to prevent study withdrawal?prevent study withdrawal?

A. B. C. D.

6%

87%

6%1%

A.A. Schedule appointment and send Schedule appointment and send reminder to the subject within 7 reminder to the subject within 7 days.days.

B.B. Schedule appointment at the end Schedule appointment at the end of the follow-up window to of the follow-up window to maximize the use of the study maximize the use of the study drug in the bottles (avoid waste).drug in the bottles (avoid waste).

C.C. Schedule appointment and notify Schedule appointment and notify subject of date and time within 3 subject of date and time within 3 weeks of appointment.weeks of appointment.

D.D. Maintain close contact with Maintain close contact with subject in between visits, subject in between visits, schedule appointment when schedule appointment when convenient for subject (be convenient for subject (be flexible), call to remind.flexible), call to remind.

When is the best time to let When is the best time to let the monitor know of a the monitor know of a subject who is not available subject who is not available for follow-up?for follow-up?

A. B. C. D.

0%

73%

2%

25%

A.A. At the end of the trialAt the end of the trial

B.B. After the subject has After the subject has missed 1 visitmissed 1 visit

C.C. After the subject has After the subject has missed 2 visits (8-12 missed 2 visits (8-12 months)months)

D.D. After the Research After the Research Team has performed all Team has performed all the suggested steps on the suggested steps on the “Lost to Follow Up the “Lost to Follow Up Checklist” formChecklist” form

If a subject expresses concern that she will If a subject expresses concern that she will not be available for the appointment within not be available for the appointment within the time window and therefore wishes to the time window and therefore wishes to “finish” their participation in the trial, what “finish” their participation in the trial, what should the RC do?should the RC do?

A. B. C.

49%

40%

11%

A.A. Communicate to the subject Communicate to the subject the need to stay on study the need to stay on study drug. Make arrangements drug. Make arrangements for the subject to see another for the subject to see another MD in the practiceMD in the practice

B.B. Agree that the subject has Agree that the subject has participated for most of the participated for most of the study and it would be OK to study and it would be OK to finish. Continue phone finish. Continue phone contact for endpointscontact for endpoints

C.C. Skip that appointment and Skip that appointment and call the subject when (s)he is call the subject when (s)he is available.available.

What is the goal of “Getting What is the goal of “Getting with the Guidelines – with the Guidelines – (GWTG)”? (GWTG)”?

A. B. C. D.

6%

17%

77%

0%

A.A. To get MDs to prescribe To get MDs to prescribe ASA to CAD patients.ASA to CAD patients.

B.B. To reduce bleeding rates To reduce bleeding rates to an acceptable level.to an acceptable level.

C.C. To reduce death/disability To reduce death/disability of CHD/stroke by 25% by of CHD/stroke by 25% by 2010.2010.

D.D. To illustrate to insurance To illustrate to insurance companies that the companies that the optimal treatment is being optimal treatment is being given to the patient.given to the patient.

The “GWTG” is based The “GWTG” is based on:on:

A. B. C. D.

1% 4%6%

89%A.A. The MD’s personal The MD’s personal

experience.experience.

B.B. Evidence based Evidence based medicine.medicine.

C.C. The type of treatment The type of treatment options that are options that are available: (PCI, CABG, available: (PCI, CABG, nuclear equipment).nuclear equipment).

D.D. Individual hospital Individual hospital survey.survey.

Which one of the following is Which one of the following is NOT a “GWTG” Performance NOT a “GWTG” Performance Measure for Cardiovascular Measure for Cardiovascular Disease? Disease?

A. B. C. D.

84%

3%9%

4%

A. Perform PCI before hospital discharge

B. Smoking Cessation Counseling

C. ACE-I / ARB for LVSD on discharge

D. Lipid lowering therapy on discharge

What characteristics are associated with statin use at hospital discharge?

A. B. C. D.

5%

89%

5%2%

A. Renal insufficiency

B. Age >60 yrs

C. Absence of diabetes

D. Measuring LDL in hospital

In following your IMPROVE-IT subjects do you discuss:

A. B. C. D.

0%

100%

0%0%

A. Cessation of smoking

B. Healthy food choices

C. Increase physical activity

D. All of the above

If a subject complains of persistent but mild headaches and wishes to come off study drug, what should the RC do?

A. B. C. D.

0% 2%0%

98%A. Agree and let patient know that it is possibly due to the study drug

B. Acquire more information from patient, review con meds, and discuss w/PI the most likely reason for headaches

C. Inform the patient there is nothing that can be done by that the patient should stay on study drug

D. Give Tylenol to the patient

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?

A. B. C. D.

3% 0%

93%

4%

A. Perform trial tasks / responsibilities on his/her own.

B. Seek support from the TIMI Hotline for questions.

C. Participate in a meetings with PI to review specific areas where help / support is needed.

D. Abandon efforts to recruit subjects

Let’s Check Let’s Check the Standingsthe Standings

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Participant ScoresParticipant Scores

11001100 Jose SaaibiJose Saaibi

10001000 Jose NicolauJose Nicolau

987.83987.83 Virginia DawneyVirginia Dawney

986.55986.55 Sebastian NaniSebastian Nani

964.18964.18 María CademartoriMaría Cademartori