Please Be Sure That You Please Be Sure That You Have Your Audience Have Your Audience

Response Keypad With Response Keypad With You. You Will Need It You. You Will Need It During This Session.During This Session.

Using your Using your Audience Response KeypadAudience Response Keypad

• Questions will be displayed along with Questions will be displayed along with the available answersthe available answers

• When the countdown clock appears, When the countdown clock appears, presspress and and releaserelease the button that best the button that best represents your answerrepresents your answer

• Your last answer will be recordedYour last answer will be recorded

• The quicker you respond correctly, the The quicker you respond correctly, the more points you will be awardedmore points you will be awarded

• There is no need to press “GO” or “?”There is no need to press “GO” or “?”

In S. America, the percent of sites enrolling > 0.5pts/mo is:

A. B. C. D.

34%

2%

16%

48%A. 25%

B. 55%

C. 75%

D. >90%

The target percentage for sites enrolling > 0.5 pts/mo is:

A. B. C. D.

24%

32%

25%

20%

A. 50%

B. 75%

C. >80%

D. 100%

Data Submission/entry should take place:

A. B. C.

33%

8%

58%A. <2 days after visit

B. <10 days after visit

C. Within 1 month after visit

What is the primary reason that rapid data submission is so important?

A. B. C. D.

73%

5%

18%

3%

A. Accurate up to date information can be provided to the Data Safety Monitoring Board

B. Payment to site can be made faster

C. Protocol adherence can be assessed

D. Allows the sponsor to review unblinded data

Why is the rate of permanent discontinuation of study drug of 21% worthy of discussion?

A. B. C.

63%

22%15%

A.The rate diminishes our ability to demonstrate superiority

B.The rate improves our ability to demonstrate superiority

C.The Regulatory Authorities may decide that the rate is too high and will not review the trial results

The achieved LDL levels observed thus far in IMPROVE-IT range from:

A. B. C. D.

16% 16%

2%

67%A. ~100-125mg/dL

(2.5-3.0 mMol/L)

B. ~53-62 mg/dL (1.4-1.6 mMol/L)

C. ~25-50 mg/dL (0.6-1.3 mMol/L)

D. None of the above

The Key Factor associates with enrollment success is:

A. B. C. D.

9%

65%

17%

9%

A. RC level of involvement = 25%

B. Screening 1x/day

C. Checking with CCU and Cath Lab schedules

D. Involvement of PI

Informed Consent should be undertaken by:

A. B. C. D.

3%

55%

39%

3%

A. Research Coordinator

B. Local MD/GP

C. Principal Investigator

D. RC and PI with local MD support

Which of the following best describes the importance of trial commitment by the Research Team?

A. B. C.

68%

10%

23%

A. The level of commitment determines the overall success of trial completion

B. Commitment by the PI generates interest locally at the site

C. Protects the patients enrolled in the trial from unnecessary exposure to study drug

Elevations in HDL-C are associated with low levels of LDL

A. B.

58%

42%

A. True

B. False

Lower levels of HDL-C are found in patients:

A. B. C. D.

22%

0%

70%

8%

A. Who exercise

B. Who consume a low saturated fat diet

C. Who are obese and sedentary

D. Consume 2-3 alcoholic drinks/day

HDL action that may be anti- atherogenic include:

A. B. C. D.

59%

5%3%

33%

A. Reverse cholesterol transport

B. Lower the inflammatory activity

C. Lower the formation of bile

D. Lower the excretion of cholesterol by- products

Niacin increases the HDL-C levels by up to 35%

A. B.

30%

70%A. True

B. False

Torcetrapid works through inhibition of:

A. B. C. D.

5%11%

77%

7%

A. Renin angiotension system

B. Preventing thrombin formation

C. Cholesteryl Ester Transfer Protein

D. LDL Formation

What should the IMPROVE-IT enrollment window be?

A. B. C. D.

34%

8%11%

47%A. < 10 days (no change)

B. < 14 days

C. < 20 days

D. 30 days

If the window was increased to greater than 10 days, what percentage (%) of enrollment increase would you expect at your site?

A. B. C. D. E.

22%

36%

20%

7%

15%

A. No change in enrollment

B. Up to 10% increase in enrollment

C. 11-20% increase in enrollment

D. >20 % increase in enrollment

E. Don’t Know

Let’s Check Let’s Check the Standingsthe Standings

Please Be Sure That You Please Be Sure That You Bring Your Audience Bring Your Audience

Response Keypad With Response Keypad With You Tomorrow Morning. You Tomorrow Morning. You Will Need It During You Will Need It During

The First Session.The First Session.

Reminder:

Participant ScoresParticipant Scores

1150.641150.64 Alfredo LozadaAlfredo Lozada

1083.641083.64 Sandra RuizSandra Ruiz

1048.911048.91 Luis CartasegnaLuis Cartasegna

1048.21048.2 Maria PlastinoMaria Plastino

10331033 Martín NajensonMartín Najenson