Home    Polls    Polling Results- October
Polls
Polling Results- October
1. Have you had an experience with a cardiac safety (QT) study in the past 12 months? 24 months?

12 months 69.6%
24 months 4.3%
No 26.1%

 

2. Do you believe that the issue of clinical cardiac safety has been addressed by recent regulatory guidance:

Well 0%

Adequately but some issues remain

47.8%

Some major issues have not been addressed yet

43.5%

Cardiac safety issues remain largely unresolved

4.3%
Not my area of expertise 4.3%

3. In your opinion what issues are the highest priority to be addressed in clinical cardiac safety evaluation:

More accurate arrhythmia liability characterization (e.g., reduction of false-positives and false-negatives, quantitative characterization of risk when some arrhythmia risk is expected)

60.9%
Size and cost of the clinical trials 26.1%
Speed of clinical trials 0.0%
Not my area of expertise 13%
Other (please specify)

4. Are you satisfied with the current cardiac safety assessment in the clinical development phases (e.g., E14 guidance implementation)?

Very satisfied, cardiac safety assessment is no longer a problem 0.0%

Largely satisfied, but some issues remain to be addressed

34.8%

Somewhat dissatisfied, significant issues remain

56.5%

Highly dissatisfied, the issue remains largely unresolved and/or the solution introduced more problems

8.7%
Not my area of expertise 0.0%

 

5. Do you agree with the statement: the need to conduct a TQT study in later clinical development leads to termination of potentially useful and viable drug candidates in earlier phases (preclinical and early human trials)?

Agree 60.9%
Disagre 30.4%
Not my area of expertise 8.7%

 

This poll is still open.  Participate in this poll.