By Deborah Borfitz
March 24, 2008 | Patient recruitment and site selection expert Provisio Inc. has a new service to help trial-sponsoring companies better assess protocol feasibility -- line by line and patient by patient.
The company’s mammoth iTrials Data Universe contains information from more than 500,000 physicians with unique diagnoses/treatment histories on roughly 60 million patients. “Our data sources include EMR [electronic medical records], claims data, prescription and lab information, 1572 records, and other descriptive information such as physician profiles and referral patterns,” says Mike Hassell, CEO of Provisio.
Using proprietary weighting and scoring methodologies, eligible candidates for a protocol get ranked and stratified in order of confidence, says Hassell. Patient-level data is connected across multiple sources but “de-identified” as required by the Health Insurance Portability and Accountability Act.
Assessing protocol feasibility is a bit like fishermen who use a bass meter to help locate fish of a certain type, age, and size, says Hassell. iTrials searches its “virtual environment” to learn how many there are and where to look for them.
Whether enough patients will enroll in a protocol is a notoriously perplexing question, as enrollment goals are missed 80 percent of the time, says Hassell. Companies end up spending millions of dollars and years of time on untenable protocols.
One customer was shown that the mortality rate for a pediatric condition was so high that few patients are available in a study’s targeted age range, says Hassell. Another trial sponsor learned it could triple the eligible patient pool by enlarging the age range by ten years.
In some cases, exclusion criteria disproportionately affect the gender makeup of the patient pool, says Hassell. Some time ago, Provisio uncovered obstetrician-gynecologists as an unexpected source of schleroderma patients needed for a treatment study. “The incidence rate is high for women and the OB/GYNs basically were treating the symptoms of this incurable disease.”
Patients’ proximity to an investigative site tends to be an even bigger issue than either age or gender, says Hassell. “People don’t want to travel 30 to 50 miles for a protocol, especially the sickest ones.”
Protocol feasibility has no widely accepted definition or boundaries, says Hassell. The trick is to “ask the right questions of the data. Every project is its own.”
Using data is a key alternative to surveys of physicians’ “intuition,” which is neither actionable nor particularly reliable, says Hassell. “Doctors tend to overestimate how many people they have for a trial.”
The goal of the iTrials Data Universe is to “increase the size, scope, and depth of data” solely for the purpose of improving clinical trial success, says Hassell. “The longer we go, the more experience we’ll have with different physician offices.” That will provide yet more insights about clinical trial risks before companies make significant recruiting investments.
The new iTrials service can be purchased alone or as a “preliminary step to a larger site selection and recruitment project,” as has already been done for several large pharmaceutical companies, says Hassell. iTrials can suggest “intelligent locations” to hold trials, forecast a recruitment timeline, and assess enrollment probabilities. Provisio also will recruit physicians of targeted patients to be investigators.
Cost of the iTrials service is “five figures, high or low depending on what’s needed,” says Hassell. “It can grow far into six figures if we also do site selection and recruitment.”