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Mike Hassell

Eighty percent. That’s the percentage of patients who answer an advertisement looking for candidates for a clinical trial who aren’t eligible to participate. That’s also the percentage of clinical trials that “end up in rescue mode,” according to Mike Hassell, president and CEO of Nashville-based Provisio Inc. “They do not meet their deadlines nor their quotas for number of people they’re seeking. A lot of sites are set up that never recruit enough people, and they have to be shut down.”

Founded in 2003, Provisio (pronounced Pro-viz-eo) has found a way to drastically improve those dismal statistics. “Essentially, we pick needles out of haystacks, and we use data to do that,” Hassell explained. The company’s offering is called iTrials, which is technology designed to search through mounds of patient information to find ideal candidates for particular trials and even to determine where trial sites should be located to access the most eligible patients. Accessible to iTrials is health information on more than 64 million people and more than 250,000 doctors. “We saw an opportunity to use technology in a way that complies with HIPAA,” Hassell said. “We had this vetted and certified by external parties, both statistically and legally. It’s very important that we’re properly respecting HIPAA laws.”

Once sources of the data (health insurance claims, hospital electronic medical records, pharmacy prescription information and more) are convinced that patient confidentiality is protected, Hassell said, “ultimately, they’re usually pretty quick to see that this is very innovative, and it’s not currently being done in this way by anyone else.” Thanks to highly automated data feeds, the information is continually updated and augmented.

Because each clinical trial, whether for a pharmaceutical company, a biotechnology research firm or a medical-device manufacturer, is different, the key to iTrials is the inclusion/exclusion criteria programmed into the system. The more finely honed the search instructions, the more likely that the patients identified will be ideal candidates for a particular trial. Demographic information such as age, sex and location are common criteria, yet what makes iTrials unique is the ability to find patients with specific diseases or health challenges who, for example, are at a certain stage of the disease or who already take a certain medication to manage their symptoms.

Hassell noted that ICD-9 codes (the “International Classification of Diseases, Ninth Revision,” used by the National Center for Health Statistics) categorize diseases “up to four decimal places,” and the iTrials technology can handle that specificity. “Now, that might not be very many people. Then we can back off a decimal or two and have a broader range of diseases,” he said. “We help our customers see how many people are out there as we turn the dials in different directions.” That’s something that can’t be accomplished simply by running newspaper, radio or television advertisements in a particular locale. “There are dozens of requirements for these trials, but only a few of them can be articulated in an ad,” he added.

The end product from iTrials may be a written report or a series of electronic submissions to the client, which may then contact the physicians of patients who are identified as potential trial candidates. iTrials never knows the identify of the patients, only the physicians who treat them. Then, at the physician’s discretion, he or she may discuss with the patient whether the trial is a good opportunity. Hassell noted that identification of some patients might even be a lifesaver if a terminally ill patient hadn’t before realized that there’s an investigator nearby trying an innovative treatment.

iTrials services don’t end there, however. Clients may also look to iTrials to make contact with the targeted physicians, confirm patient eligibility and help in referring patients to study sites. iTrials may also track subjects through the steps of the enrollment process.

Hassell said clients are also recognizing the wisdom of hiring iTrials before study sites are selected. “Our customers are beginning to see why it’s beneficial to hire us early on,” he said. Once locations of potential trial participants are mapped, iTrials identifies clusters of patients and recommends sites. “It’s like a giant bull’s-eye. We paint a map that shows where there are people in the region who appear to be qualified based on the data we have,” Hassell explained. “We can show that some of these sites are lousy and some of them are really good.”

Hassell ranks the roadblocks that clinical trials could run into as “one of the top three or four problems in the pharmaceutical business. … If you look at the big picture, the industry’s ability to bring new therapies to market is critical — and that means getting through clinical trials.” Because of patent timing, drug makers have a 17-to-20-year “window of opportunity,” he said, and it can take eight years or longer to bring a new product to market. “So if they can shave any time off of that, it’s extremely valuable,” he noted. That’s where iTrials can help.

The technology also holds promise as pharmaceuticals move to customization — so-called designer drugs. “The smaller the audiences are, the more demand there is for targeting. iTrials has the ability to make the process efficient enough to be economically viable for these increasingly specific drugs because we can pick the needles out of the haystack.”

Already, Provisio has been hired by “several dozen” companies, Hassell said.



May 2008

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