CT Software

Software for the Design,
Interim Monitoring and
Simulation of Flexible
Clinical Trials

Design Smarter Clinical Trials and Cut
Development Costs With the NBScience CT Solution

Hundreds of biostatisticians and clinicians rely on NBScience CT to design,
simulate and monitor flexible clinical trials. Originally developed
specifically for group sequential trials in which early
stopping for efficacy was the objective NBScience CT has since
emerged as a critical tool for the growing number of investigators
who wish to employ interim monitoring in their Phase II,III
and IV clinical trials.NBScience CT facilitates early termination of futile
studies and unsafe treatments, sample-size adjustment,and
interim monitoring for administrative purposes.

As an alternative to standard, fixed-sample clinical trials, flexible clinical trials use sophisticated statistical
methodology to permit interim looks into Phase II, III, and IV trials without jeopardizing the type-1 error or
losing control of the study's power. For investigators, this means being able to understand the results of trials
sooner, terminate futile studies earlier, fast-track winning treatments and indications, and deploy resources
more precisely and intelligently. In a competitive environment where getting the right drug to market as
quickly as possible is critical, sponsor companies cannot afford to lock themselves into time-consuming trials
when a flexible approach is possible.

The NBScience CT solution helps you answer the questions that matter, at the design stage or while monitoring the trial.NBScience CT can help study sponsors answer many important questions such as:

 What will I gain from planning one or more interim
analyses on my data?

 The current observed effect size is small. What would it
take to turn this study around?

 There is a competing product currently in trials. I've only
seen 50% of the required number of events.How long do
I have to wait for the remaining 50% of events? By how
much can I shorten the waiting time if I accrue more
patients?

 Is this trial in trouble? How can I salvage it? If we stop
now, what can we learn?

 Can I stop this trial early for futility? For efficacy?

 Do I need to readjust my sample size mid-stream?

Claim your advantage

Designing studies with planned interim monitoring is a complicated task requiring intimate familiarity with
sophisticated statistical methodology. The NBScience CT solution puts this methodology inside a powerful and
elegant user interface, so that investigators can spend their time evaluating design options and trial data,
rather than programming software.NBScience CT gives sponsors complete control over the study's type-1 error
and power. And, by having the right tools at hand when the study is underway, sponsors, data safety
monitoring boards, and regulators can make informed, accurate decisions about the trial.
Using NBScience CT to design and monitor flexible clinical trials means spending less time and money on treatments that don't work, having fewer underpowered, failed trials of treatments that do work, and saving
valuable resources by lowering development costs and bringing drugs to market sooner.

A Complete Software Solution for Clinical Trial Design, Simulation and Interim Monitoring

Trial Design
 Design multiple trials quickly through a point
and click, Excel based interface, and compare
trial designs side-by side.

 Calculate sample size and stopping boundaries
for superiority, futility, and non-inferiority
studies. Design information based studies
that allow for sample size adjustment.

 Choose stopping boundaries from the
Wang-Tsiatis, Lan-DeMets, and Haybittle-Peto
families,or derive stopping boundaries from a
series of published error-spending functions.
Interim Monitoring Module

 Simultaneously track the test statistic, re-computed
stopping boundaries,error spent,conditional
power and post-hoc power through a convenient
dash-board style user interface.

 Make informed decisions about trial outcome
and stopping probabilities.

Simulation
 Simulations allow statisticians, clinicians and
regulators to understand the implications of
different design possibilities so that the best
design can be chosen.

 Verify a study's test statistic and power
Tables, Graphs and Reports

 Numerous tables and graphs display information
on a variety of scales and allow statisticians
and non-statisticians to easily grasp the impact
of trial data.

 All graphs, tables and reports are Microsoft
Excel based and fully exportable to other
documents.

Key Benefits NBScience CT
The NBScience CT software solution is completely customizable and scalable. The NBScience CT feature
set is configured to meet customer need, and includes the following capabilities:
A Complete Software Solution for Clinical Trial Design, Simulation and Interim Monitoring

 Easier to learn and use than any other comparable
product on the market; no programming skills
necessary.

 Extremely powerful and flexible

 Clear Excel-based graphs and tables make
communication with non-statisticians easy.

 Unique trial simulation capabilities let you verify
designs and plan for different outcomes.

 Data can be viewed on multiple scales: p-value,
Z-scale, mean, and others.

 New families of published spending functions allow
for futility-only stopping rules.

 Direct monitoring feature allows users to monitor
any study, even if it was not originally designed to
have interim looks.

 Fully customizable to create simulations and trial
specific interim monitoring worksheets.

 Fully validated and used by all divisions of the FDA
(CDER, CBER and CDRH).

Contact NBScience for
more information on NBScience CT and how it can help you with smart protocol design.

head_office@nbscience.com

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