FACTS 8.1.0 Release Notes

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Introduction

FACTS 8.1.0 is now available for download via FACTS Cloud. Its main new features are:

  • Seamless Phase 2/3 (“Staged”) designs using ordinal endpoints.
  • Two new Quick Starts to facilitate the creation of Promising Zone and Goldilocks designs.
  • New operational QOIs tracking the trial status.

FACTS Core and Staged Improvements

  • In Core and Staged designs, the “QOIs per Interim” scenario results graph will now display the number of outcome types at each interim (success, futility, inconclusice, etc.) as well as the number of simulations that have reached the given interim.
  • In Core and Staged designs, the “QOIs per Interim” scenario results graph will now handle the display of simulations with flip-flop outcomes (Success->Futility, Futility->Success) correctly.
  • In Core and Staged designs, the “Per Sim: Interim Info” scenario results graph will correctly extend the subject information plots (enrolled, completers, dropouts, etc.) to the final analysis when the trial has stopped early but has follow-up.
  • In Staged designs, the “QOIs per Interim” scenario results graph will correctly handle the display of early/late graduation from Stage 1 to Stage 2 outcomes.
  • In Staged designs, the “Per Sim: Interim Info” scenario results graph will correctly handle the display of simulations which have stopped in Stage 1.
  • In Staged designs, the complete data analysis (CDA) Stage 1 summary file will now correctly match header columns with the underlying data.

FACTS Enrichment Design Improvements

FACTS Platform Trial Improvements

  • In Platform Trial designs, the “QOIs per Update” scenario results graph will now display the number of outcome types at each interim (success, futility, inconclusice, etc.) as well as the number of simulations that have reached the given update.
  • In Platform Trial designs, the “QOIs per Update” and “Per Sim: Interim Info” scenario results graph will now handle the display of simulations with flip-flop outcomes (Success->Futility, Futility->Success, Success->Inconclusive, Futility->Inconclusive) and “late” outcomes (Late Success, Late Futility, Inconclusive) correctly.
  • In Platform Trial designs, changing a non-default QOI to a default QOI (when the referenced QOI is used in stopping criteria) will no longer result in simulation errors.

FACTS Dose Escalation Improvements

  • When both the MED and MTD are estimated to be above the investigated dose range, the selected OSD is now -1, i.e. none of the investigated doses is selected as OSD.

General Improvements

  • The runtime memory usage of FACTS has been improved significantly. In particular, the number of Graphic Device Interface (GDI) objects used by FACTS has been reduced significantly when opening multiple designs with the same instance of FACTS.
  • Cancelling simulations when there are existing scenarios that have been successfully simulated will no longer result in the “Across Scenario” graph popping up erroneously multiple times.
  • The time taken to generate simulation scenarios when creating new simulation profiles has been improved. This becomes particularly noticeable when the design contains a large number of simulations scenarios, some of which have been already simulated.

Please contact us regarding any questions.