This section presents regularly, a hot topic selected from Pharma or Biotech news.

Ariana: Bettering Trial Design with In-Depth, Multi-Endpoint Analysis

By Deb Borfitz from eCliniqua

April 5, 2010 | Paris-based Ariana Pharma has a decision support platform, known as KEM (Knowledge Extraction and Management) Clinicals, which can be used to complement statistical analysis software like SAS to mine otherwise neglected clinical trial data and optimize the design of subsequent protocols. With the technology, the company can “guarantee [sponsors] we have exhaustively looked at every combination of patient characteristics” to hypothesize which subject types will benefit most from the experimental treatment—and then test those theories against multiple endpoints, says CEO 



Mohammad Afshar


Coupling of the two technologies allow hypothesis testing on phase II and both large and small phase III trial data, says Afshar. Traditional statistical methodologies are better suited to larger numbers of patients and focus on one objective at a time—say, pain relief or improved functional response. KEM Clinicals thus helps trial sponsors focus a product’s indications and explore endpoints earlier in the drug development cycle.

KEM Clinicals is stand-alone software with a graphical interface, says Afshar. It was developed in collaboration with a French public research group and four biopharmaceutical firms—GlaxoSmithKline, Pfizer, Novartis, and Merck & Co.—and has been in use for over two years now.

Data mining tools of this type are used extensively to dissect consumer behavior and to detect safety issues in other industries, says Afshar. “In clinical trials, they’re very new. That’s why we’re getting so much interest now.” Currently, Ariana is working with about 20 large pharmaceutical companies. Interest is building among small biotechnology firms “even keener to protect their investment and maximize the amount of information they can extract [from studies].” One of its latest clinical design optimization projects is with Fovea Pharmaceuticals, based on analysis of data from phase II trials of its ocular drug Pednisporin.

Ariana, founded in 2003, is a spin off of the Institut Pasteur. It now does business in the U.K., U.S., and Switzerland in addition to France.

Sponsors have used KEM Clinicals to fashion successful trials based on lessons from failed trials, says Afshar. They’ve also used the technology to produce additional information about a drug’s therapeutic benefit for specific sub-populations, with a positive impact on product pricing. When faced with the dilemma about which endpoints to use, companies have employed KEM Clinicals to rank the alternatives in order of achievability.

In the realm of personalized medicine, KEM Clinicals could be used to look at combinations of patients’ phenotypic features along with their age, gender, weight, disease stage, and treatment history to even more precisely predict treatment outcomes, says Afshar. “There is currently a huge body of data captured in clinical trials that is never used unless something goes wrong.” Ariana is already using its technology to analyze combinations of genomic and biological biomarkers that can be used diagnostically to stratifying patients within established disease categories.