<<Question - How does it work with interim looks, Data Monitoring Commitees timing, Press Releases, etc. If a trial is designed to have 2 interim looks based on the number of deaths in the total trial population - 1) is there a lag in time before the DMC looks at the data?, 2) is the Company obligated to make a PR stating that the interim death number was reached and the results so far indicate that the trial should continue or be halted?, 3) is it cut and dry - the trial achieves specific results dictated by an SPA - is the trial halted or does the DMC ordinarily side on caution and recommend that trial continue to the end?, and 4) are there lag times in when an interim look is expected and co. PRs or DMC meetings? Thanks for any insight you can provide.>>
1. Once the # of death trigger has occurred, it probably takes no more than a few business days for the DSMB to compare the results for the treatment and control arms.
2. Once the DSMB has informed the company of its recommendation, then the company is obligated to inform the public if the results are material, which they would be to all but the biggest pharmas...and the biggest pharmas would be obligated to inform the public anyway if the indication is large enough to affect future revenues.
3. Depends on the specifics of the SPA. In most cases, I would imagine that if the prespecified stat sig p value for the interim look isn't met but the treatment arm is still performing better than the control arm, then the trial will continue.
4. Not sure how to answer as I don't understand the phrasing.
