“Ensure evidence generated meets the needs of the objectives of the clinical trial.” PAREXEL Pragmatic™…
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It is important that clinical trials produce clear evidence for safety, efficacy and cost effectiveness to be commercially successful but it is also important to ensure you have balanced accuracy with cost effectiveness.
The challenge of gaining reimbursements as well as regulatory approval is becoming more and more prevalent and many pharmaceutical developers are now realizing the importance of evidence in clinical trials. Although evidence is essential it’s important that it’s also in line with cost effectiveness. This can be done by following these three steps:
1. Review previous submissions for compounds similar to your own to avoid making the mistakes others have made before
2. Make sure you have a large sample group to compare overall survival rates for the groups in your clinical trial
3. Carry out a power analysis remembering that the larger a trial, the greater its power and as a result the greater its cost.
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