FACTS 6.2.4 Release Notes

November 26, 2018

Berry Consultants would like to announce a new maintenance release, FACTS 6.2.4. FACTS 6.2.4 contains the following fixes to the FACTS 6.2.3 version:

Updating to 6.2.4 is recommended for those of you wishing to use predictive probabilities in FACTS Core TTE, in combination with a TTE predictor endpoint:

• In FACTS Core with a Time-to-Event end point and a Time-to-Event predictor, the imputations of final event times for subjects with a predictor event but no final event during the estimation of “predictive probability of success at full enrolment” could produce an error in the prior version. There are two rare situations in FACTS 6.2.3 that uncover a bug in the dose escalation simulator and causes it to produce an error:
• In FACTS Dose Escalation, in the N-CRM with only 3 doses the simulator could produce an error during some dose escalation decisions.
• In FACTS Dose Escalation CRM (Toxicity) could produce an error when simulating 2 samples. The remaining, minor fixes in FACTS 6.2.4 are:
• In FACTS N-CRM, the GUI was improved to handle the “Variant” options making is easier to change them once they were set.
• A fix to FACTS Dose Escalation 3+3 (!) – improved to handle the circumstance when the starting dose is not the lowest dose, and the dose assignment de-escalates to below the starting dose and validates the next lower dose.

Plus we improved the labeling of a class of prior parameters:

• In the FACTS GUI labels of parameters for prior with an Inverse-Gamma distribution the wording has been changed from “mean value” (which is technically incorrect) to “central value”.