The new normal for clinical development

By Deborah Borfitz

Can the emergence of new technologies improve the miserable state of clinical trials?

Seeking Solutions

Centerphase Solutions serves as the Mayo Clinic's single external channel for industry-funded studies and assembles recruitment and communication plans on its behalf. To ensure a protocol is feasible, inclusion and exclusion criteria first get analyzed quantitatively against de-identified patient information in Mayo's expanding Enterprise Data Trust. Chart reviews and subject matter experts then qualitatively evaluate the factors impacting subject willingness to participate in the trial. The result is a more confident enrollment projection as well as pointers to which sites are likely to perform well and improvements in the site selection process.

President/CEO Gary Lubin notes that Centerphase has to date conducted more than 25 protocol reviews across study phases and therapeutic areas for ten pharma companies. In the first of four studies started at Mayo, Centerphase took 155 days to get the first patient enrolled in a phase IIb neurological study-well below the 210-day median for all studies-and could have done so in 81 days but for contractual delays. The 21-day period between site activation and first patient enrolled was notably compressed relative to the 90-day median.

Impressively, the Mayo Clinic principal investigator (PI) enrolled patients 30% faster than the other 150 sites on the study, and within the shortest relative timeline (1.2 months), says Centerphase chief clinical officer Beth Harper. Eleven of the 12 patients screened were ultimately enrolled. The enrollment period closed earlier than expected, she notes, preventing the PI from achieving his target of 15 subjects. The study effectively substantiated the predictability of the Centerphase-Mayo Clinic model, with actual versus planned pre-screen, consent loss, and screen fail ratios within 10 percentage points.

Enrollment statistics on a subsequent phase III gastroenterology study with the same sponsor are yet more compelling. Mayo was among the first wave of sites initiated-a rarity for an academic medical center (AMC) with its own institutional review board (IRB)-and shaved another three weeks from the site activation timeline relative to its initial efforts. Mayo enrolled three times as many patients as the average site and did so at a 50% faster rate.

The Centerphase vision is to build a nationwide network of AMCs and medical systems as study "centers of excellence," says Lubin. A second AMC is in the process of coming on line, with Centerphase in "serious discussions" with three other AMCs as it plans for the build out. Theoretically, data can be extracted in the aggregate across disparate EHR systems as long as Health Level Seven (HL7) and other standards for interoperability are followed and definitions of data are consistently applied. But integrating the EDT with other major data sources could prove tricky, says Hardison, who serves on Centerphase's advisory board. Mayo is one of few provider organizations that have put business processes in place to ensure EHR data can be exploited for clinical development.