Using Software to Boost Clinical Trial Design



Pharma IQ
09/20/2010

 When considering the key challenges that new drugs face on their route to widespread use, clinical trials are undoubtedly one of the most vital. The results of such assessments play a key role in shaping the future of new treatments including, perhaps most importantly, whether they will ever reach the wider public.

 Due to the massive role that clinical trials play as new drugs take steps towards the
market, it is unsurprising that the design of them is carefully considered by all pharmaceutical organisations. In order to address the issue, companies are making use of a range of facilities - including technological or software solutions, to ensure their trial designs are suited to their needs.

A number of organisations have expertise in creating such programs, including the likes of OpenClinica and TrialWorks. However, the one which has made the most recent announcement on the topic is Cytel. The body claims impressively that 47 of the top 50 biopharmaceutical firms make use of its clinical trial design services and software. However, the firm will be hoping that its latest innovation will push the figure up even further.

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Earlier this month, Cytel confirmed the launch of Compass, industrial software designed for use in adaptive dose-finding studies which make use of either frequentist or Bayesian methods. According to the firm, the new system could prove beneficial to pharmaceutical firms keen to discover information for use in confirmatory development, as it offers a workflow based on adaptive standards that also complements dose identification study construction.

Dr. Yannis Jemiai, product manager for Compass, said: "We're very proud of our collective work to place modern, industrial strength adaptive design tools in the hands of the drug developers engaged in dose-finding clinical research."

The software, which Cytel will be hoping proves as popular as its adaptive and group sequential software East, features a built-in simulation engine which assesses potential design options and also builds visualisations of trials characteristics. According to the company, such systems will help to boost understanding of tests among drug development researchers and the regulatory bodies they are preparing work for.

"Compass users will more easily choose the best options and conduct successful adaptive trials. Our trial simulations implementation is based on techniques proven to help sponsors to make knowledgeable decisions time and time again," Dr. Jemiai added.

The introduction of Compass sees Cytel's adaptive design software extended into the field of phase two dose-finding clinical trials. According to the company, its release may also be timely, particularly due to the US Food and Drug Administration's new draft document on adaptive trial guidelines. The documentation particularly focuses on the identification of optimal dosage levels.

In addition, the launch of the software has come around 12 months after Cytel introduced the first details of clinical trial design and analysis software SiZ, which was designed to analyse and compare a range of trial approaches.

It can be suggested that the introduction of Cytel's new software highlights two things. As well as showcasing the continued growth of Cytel and its portfolio of software solutions, it also provides major evidence of how the design of trials, in particular adaptive ones is becoming a major concern.

When viewed alongside the fact that authorities across the globe are releasing draft guidance in relation to the issue, it has become clear that pharmaceutical firms need to pay more attention to the area. The development of new software solutions like those developed by Cytel and its rival are likely to be a big helping hand as companies do so in the coming years.

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