FACTS 6.2.5 Release Notes

Febuary 20, 2019

Berry Consultants would like to announce a new maintenance release, FACTS 6.2.5. FACTS 6.2.5 contains the following improvements to the FACTS 6.2.4 version:

This release addresses three rare situations in FACTS 6.2.4. If any of your designs replicate these exact circumstances you are recommended to upgrade to FACTS 6.2.5:

• In FACTS Staged Design with a Time-to-Event end point and a predictor, if using, in stage 1, a predictive probability of success in stage 2, the imputation from the predictor was not being performed correctly.
• In FACTS Staged Design, if all recruitment is completed in the first stage, so that only follow up remains in the second stage, if the second stage contains interims by time, these interims were not simulated.
• In FACTS Core, if a Dunnett’s adjusted p-value QOI was defined and there was an additional p-value QOI defined after it, the results reported for the Dunnett’s adjusted QOI were corrupted.

The remaining, minor enhancement is in the FACTS 6.2.5 GUI:

• In FACTS Core TTE, if QOIs using a Predictor endpoint were defined over and above the default ones, the GUI could delete these on re-opening the “.facts” file. Should this have happened to you, you would have seen FACTS display a warning message that it was deleting these QOIs. The GUI has been fixed so that this deletion no longer occurs. There have been no changes to Dose Escalation or Enrichment Designs. There have been no updates to the documentation or examples.