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Clinically correct behavior
PHILADELPHIA—Though the company's name may be all-lowercase, Surveillance Data Inc. (SDI) certainly doesn't think trialytics is small time—hence the provider of real-time electronic healthcare data for the pharmaceutical and healthcare industries recently acquiring trialytics, which deals in clinical trial site identification, selection and patient recruitment.
As a new subsidiary of SDI, trialytics is being charged with streamlining clinical trial processes—through enhanced site identification and patient recruitment—and providing improved assessment of clinical trial protocols.
The new subsidiary, which will remain known as trialytics, reportedly will leverage SDI's market-leading longitudinal, de-identified patient data and analytics with trialytics' clinical trial expertise to expand the development of strategies and products for protocol development and site and patient recruitment for clinical trials.
"One of the biggest complaints about clinical trials is that they are very difficult to pull off well, and that is mainly because they have such a departure from standard medical practice," notes Malcolm C. Bohm, president of trialytics. "We can apply medical reality to protocol design and help study designers better simulate and understand the impacts of various exclusion and inclusion criteria."
For example, if researchers need to design a study in metastatic non-small-cell lung cancer and the patients have to be naïve to chemotherapy, that is a very limited set of criteria. What are the chances, Bohm notes, that patients with late-stage lung cancer will have either not seen a physician or chosen to ignore chemo as an option—and if they have, what are the chances of being able to endure the clinical trial?
"We apply filters against the endpoints and criteria so that designers can better determine if it is truly necessary, or realistic, to exclude or include various groups," Bohm says.
SDI's data analytics and modeling capabilities are expected to help sponsors more easily locate physicians who treat protocol-eligible patients with specific disease profiles or patients living in demographic areas that hold a disproportionate number of people with a given disease.
Furthermore, access to extensive, aggregated, anonymized, electronic medical record and healthcare claims data will contribute to more realistic protocol development and more rapid and effective site selection and patient recruitment.
"The synergies of the companies will allow clinical trial sponsors to optimize study design and mitigate the risks of implementing clinical trials, resulting in decreased time to market for effective drugs," Bohm says. "This partnership will deliver tremendous advancements in efficiency and productivity, which will benefit pharmaceutical manufacturers, clinical research investigators and, in the long run, patients."
"Only 3 to 7 percent of patients in the U.S. enter clinical trials in any given year, leaving a huge, untapped pool of patients who can now be effectively targeted," he adds. "Moreover, with 80 percent of all clinical trial participants coming from just 20 percent of sites, there is a tremendous need to identify clinical investigators who treat large numbers of protocol-eligible patients and effectively draw those patients into trial opportunities."