FACTS 6.1.0 Release Notes

November 2, 2017

1 Introducing FACTS 6.1.0

Berry Consultants is delighted to announce that FACTS 6.1.0 is ready for release! Building on FACTS 6.0.0, FACTS 6.1.0 adds two new Dose Escalation simulation types: “FACTS 2D-CRM” and “FACTS mTPI”:

  • FACTS “2D-CRM” is a simulator that runs simulations of dose escalation trials testing combinations of doses from 2 drugs. The implementation follows that of the 2D-CRM prototype that was available earlier this year.

  • FACTS mTPI is an implementation of Yuan Ji’s “Modified toxicity probability interval method for dose-finding trials”.

FACTS 6.1.0 also adds a major piece of simulation functionality across (almost) all FACTS engines: ‘Design Variants’, these allow you to have within one “.facts” file, multiple designs with different maximum sample sizes. This makes it much easier to estimate the required sample size for a design. The feature includes the ability to mark specific treatment arms or groups as ‘correct choices’, and FACTS now summarizes not only the proportions of successful and unsuccessful trials, but also proportions of successful trials that also made correct choices.

FACTS 6.1.0 is fully backwards compatible with FACTS 6.0.0 and 5 – it can load and run all your FACTS 6.0.0 and FACTS 5 designs – and then use new FACTS 6.1.0 features with those designs. You can have FACTS 6.1.0 and FACTS 6.0.0 installed on the same machine, so it’s easy to have a transition period as you move to the new version.

2 Key New Features

  • FACTS Dose Escalation:
    • Design Variants in N-CRM.
    • 2D-CRM
    • mTPI
  • FACTS Enrichment Designs:
    • Design Variants
    • The ability to extend hierarchical modeling with clustered model.
  • FACTS Core:
    • Design Variants
    • Better control over which frequentist calculations are performed.
    • The ability to use p-value QOIs for early success/futility decision making.
  • FACTS Staged Design:
    • Design Variants
    • There is now an ‘Analysis’ tab in Staged Design.

3 Downloading FACTS 6.1.0

The FACTS 6.1.0 release is available for download from the Berry Consultants FACTS 6 ftp repository at http://berry1.berryconsultants.com/facts_6/.

Login using:

  • Username: facts_6
  • Password: DynIrgyur4

There are, as usual, 4 files to download: Documents.zip, Examples.zip, Setup.msi, setup.exe. Obfuscated versions of setup.exe and Setup.msi have been included for those of you accessing through firewalls that prevent the download of .exe and .msi files. Having downloaded setup.e_e and Setup.m_i simply rename the file suffix before using.

4 Installing FACTS 6.1.0

As with previous version of FACTS, FACTS 6.1.0 installs on a PC. Simply place the downloaded files on the PC / laptop it is to be installed on and run the file “setup.exe”. You will need a new FACTS license key for this new version. It will be sent to you separately.

For any support questions or issues, please contact us.