How fast can your company analyze its clinical data? If a medical journal says your data are incomplete on a Thursday morning, is the turnaround time for your response a) one month b) six months or c) “it depends”?

In an era of withering scrutiny of clinical research, biostatisticians are probably the most precious element of human capital in the industry. A big fraction of their time can be frittered away with mundane and repetitive tasks such as generating charts and graphs that colleagues are unable to pull together on their own.

So we were interested to see yesterday’s announcement by Insightful Software. The Seattle firm specializes in statistical tools for several industries with its statistical scripting platform, S-Plus.

In the life sciences, Insightful provides specialized software for microarray analysis; safety data; clinical data review and designing, monitoring and analyzing clinical trials using group sequential methods.

Michael O’Connell presides over all that as Insightful’s director of life sciences. He’s one of the most engaging statisticians you’re likely to encounter, with a twinkle in his eye and a knack for explaining his software. It’s used at a variety of the largest firms in the industry.

Point & Click Ease

O’Connell says that the company’s newest product, Insightful Clinical Graphics, grew out of a surprising realization. Even Insightful customers using his arch-rival, SAS, often preferred Insightful’s applications for generating graphical elements of preclinical and clinical study reports.

So there are 13 graph types and 10-15 clinically specific templates included in the new Insightful Clinical package. “What we’ve tried to do in this product is bring as many clinical graphs that we’ve seen in the industry,” says O’Connell.

O’Connell believes the industry is becoming more visual. “You can get more rapid, comprehensive interpretation of data through graphical analysis,” O’Connell says. “The FDA has bought onto the idea of graphs. The industry is just hitting the tipping point. Customers see the FDA do more graphics, and they do more graphics.”

FDA Concern

But some of the older SAS macros for generating graphs, O’Connell says, are getting increased scrutiny from an FDA that wonders about how rigorously controlled such keyboard shortcuts are.

The Insightful Clinical Graphics tool creates scripts that are validated, and not subject to the whims of some programmer who may not currently work at the company. Says O’Connell: “The FDA would like to see a standardized set of graphics and analytics used across the industry, especially for safety. All of these scripts created from our product are being created from the options in the software. These scripts, by definition, don’t have to go through that extra level of validation that a handwritten script would.”

No PhD Required

“We’ve developed a graphical solution that helps embed our software for the workflow in submissions and reporting,” says O’Connell. Needless to say, the generation of charts and graphs in a regulated environment is considerably more difficult than rigging up something in Microsoft Excel.

Part of the idea is that any authorized user, with any level of statistical expertise, can choose a chart or graph and get what they need. But biostatisticians themselves will also be using the tool.

The programmers have the technical chops to generate the same graphs using code. But they know their time may be better used by quickly dispatching simple requests for graphics. “Those guys are eager to come across to this point and click manner,” O’Connell says. “The fact that the code is there is very comforting to those guys. The statistician is in control.”

Saving A Style

Another key idea behind Insightful Clinical Graphics was that some of the work of biostatisticians could be reused in a 21 CFR Part 11 compliant manner. “You can point and click to create a graph, and that generates S-Plus script and metadata about the graph so that that graph can be reused across all aspects of the production environment,” O’Connell adds. “It allows those graphs to be reused.”

If a medical writer needed a particular graph for a report or a peer-reviewed publication, and suspected it had already been generated, he would need to search in the software—and voila!, no need to wait in line for a busy biostatistician.

11 pt. Tahoma? Or 10 pt. Arial?

“It’s clinical graphics for the whole pipeline, where most software (except for S-Plus and SAS) doesn’t play because of the burden involved in validation,” O’Connell explains. Indeed, the new tool works within a SAS environment as well as within an Insightful one.

In addition to reusing individual graphs based on a particular data set, the program allows the look and appearance of a graph or chart to be saved and reused. In many organizations, an appalling amount of time can be wasted in unspoken, Hamlet-worthy dialogues to pick just the right font, color and other stylistic nuances. Some of that silliness can now be avoided with companywide standards.

“You can have themes for your own style or a company or a journal without changing any of the content,” says O’Connell. “The data are bound to the graph. You’re just changing the style. The whole idea is separating content from the presentation layer.”

Corporate Social Networks

The new software will allow someone to say, Hmm, I do like the look of Sharon’s chart. Or, just as likely, If this chart is for an NDA, it appears that the companywide format is here.

Someone saving a report can also tweak minor aspects of the whole user interface of the chart in question. Perhaps baseline labs are now on the X-axis. That becomes searchable in the software. Says O’Connell: “You’re giving guidance in the user interface. When you save it, it might say ‘labs shift plot.’ You’re leveraging the social network of the pharmaceutical organization, allowing people to share each other’s work.”

Tagging Your Trial

In some cases, O’Connell reports, users are combining disparate elements in fairly creative ways. (There is a YouTube video on the Insightful website.) The new software pays a certain homage not just to Spotfire but also to consumer-grade Web 2.0 tools like Picasa, Google’s online photo-editing tool.

The difference is that Insightful Clinical creates a haven for regulated collaboration behind a company firewall. But the idea is the same. Meta-data about the clinical data can be easily changed. Says O’Connell: “This is like tagging your photos on Flickr. You can customize some of the labels. This enables end-users to benefit from all the talent in the social network of their organization, while minimizing multiple re-workings of similar graphical analyses.”

Critically, however, you can also run jobs in batch mode, which is central to productivity in industry. “Being able to run something in batch from a script—that’s the only way you can get things done in a production environment,” says O’Connell.

d9A2t49mkex