Automation Comes to RTSM

Editor’s Note: This article is part of a series examining popular peer-reviewed articles from years past called “Peer-Reviews Revisited: Why You Should Read Today.” You can read the other articles in this series here.

The clinical trials world is starting to adapt computer-aided design. CAD suppliers have used modular components to design and create products as diverse as jet aircraft and architectural designs since the 1980s. The pharmaceutical industry is adapting similar concepts to design, plan and operationalize clinical trials.

“Designers using CAD have at their disposal arrays of modular components and can employ and interconnect them in any way that makes logical sense,”  said independent consultant Stanley Haavik, MS, MBA, former Director of Product Marketing for Medidata Solutions and lead author for “Randomization Revolution is Brewing.”

“The designer can immediately test a design and verify correct operation without physically building a prototype” Mr. Haavik continued. “By providing a visual interface similar to CAD systems for the design of clinical trials, the trial designer is presented with a holistic environment for randomization and supply planning. The statistician or designer can know within minutes whether the design meets requirements for balance and power..”

Every clinical trial is unique, but most trials draw from a common toolbox for recruitment, screening, randomization, product supply and distribution, electronic data capture, and other elements. These same elements are used whether a trial is confined to a single site or  spread across global sites with multiple investigators.

Using CAD-like tools to design clinical trials offers multiple advantages.

• Trial design software is pre-built, pre-tested and pre-validated.      

• Once configured, trial software is ready for immediate use.

• A single web-based browser interface simplifies operations at each trial site for randomization, supply management and EDC.

• Standardized trial design software eliminates the need for costly, time-consuming creation, testing and validation of unique software for each clinical trial.

“A balanced trial design with minimum bias can be verified prior to implementation,” Mr. Haavik said. “New, improved methods are available for randomizing, implementing and operating clinical trials more simply and quickly than prevalent existing models.”