Some commentary I found about the Jupiter Trial Interim stop.
Did Early Stopping Impact on the JUPITER Results?
Despite claims made by some observers, there is no credible evidence that early stopping of the JUPITER trial had any effect on results. In fact, although the median follow-up was just less than 2 years, data accrued for those patients followed in JUPITER for between 2 and 5 years actually show a greater relative risk reduction, not a smaller estimate.
This should not be surprising as JUPITER’s Independent Data Monitoring Board (IDMB) followed rigorous principles in its prespecification that early stopping would require proof beyond reasonable doubt, and all members of the IDMB were highly experienced in monitoring clinical trials funded by both public and private entities. The IDMB viewed the JUPITER’s prespecified statistical boundary as but one component required for early closure, and although that formal statistical boundary was conservative and only evaluated after an adequate number of cases accrued, the IDMB nonetheless voted to continue JUPITER for 6 additional months. During that additional time-period, the incremental data accrued confirmed again both the magnitude and statistical significance of the apparent benefit. For those concerned that the JUPITER results somehow were a result of the play of chance, it may be of interest that the exact probability value for the trial primary end point after database closure was <0.00000001. It is thus evident that the JUPITER IDMB acted in an appropriately conservative manner to ensure a fully valid estimate of treatment effect.
