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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) |
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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% |
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Largely satisfied, but some issues remain to be addressed |
34.8% |
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Somewhat dissatisfied, significant issues remain |
56.5% |
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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.
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