Next Generation Site Selection?

Health Market Science (King of Prussia, PA) is offering a new data-driven approach to site selection for clinical trials. With nine years experience under its belt with its physician masterfile and claims data, Health Market Science has integrated both datasets along with clinical trials detail into a data-driven workflow tool. The Web-based solution gives clinical trials professionals access to quantitative and qualitative insight into existing and potential trial sites.

The product is called Clinical Investigators. Matt Plack, Marketing Director at Health Market Science, said, "Our market research found that most trial site selection relied on fragmented and outdated data limited to current sites, rather than the full universe of potential sites. Past site performance is only one indicator, so we focused on delivering real insight into which sites had the right location, affiliations with institutions, and potential subjects based on claims volume."

In addition, Plack stated that they found many of the databases in use today by CROs or sponsors are not updated or managed on a regular basis, resulting in old and incorrect information about the sites. Also, these databases may not accurately reflect the investigator's current patient pool or current workload.

By hosting the workflow tool, Health Market Science is able to refresh the physician masterfile data weekly, thus ensuring that research teams have highly accurate site contact information. This can reduce time wasted in contacting nonviable investigators.

To access Clinical Investigators, trial sponsors and CROs license individual or multiple markets, which allows them to search for investigators with measurable experience in a specific therapeutic area. End users receive a user ID and password that allows them to research, save, and export detailed listings of potential investigators that can be used by other team members in the company.

The industry factors behind the investment in and development of the Clinical Investigators solution are well-known to industry veterans: the day-to-day administrative costs for delays in a trial, combined with the overall costs to a biopharm company for delaying a drug to its NDA. Trial delays come in a variety of forms, and here we speak of subject recruitment delays.

Related to subject recruitment are trends in the actual principal investigator world. Without physician investigators, there is no access to the needed patient turned subject. A notable trend uncovered by the Tufts Center for Drug Development is the high turnover rate among clinical investigators. Specifically, the basic fleeing of veteran investigators from the conduct of clinical research at a rate of 36% per year. The reasons? Tufts noted that profits for investigative sites are being eroded by increasingly complex protocol designs, subject eligibility issues, and cash flow problems at the site—all are cause for an investigator to leave the industry.

Clinical Investigators addresses this trend by allowing site recruitment teams to expand the pool of new potential sites when known sites decline participation. According to Plack, "With the pool of known investigators static or shrinking, we're able to offer insight into other sites that may be worth considering. It gives them a wider view." As an example, Plack offered, "After filtering and sorting their results, they may find that a physician without experience is affiliated with a hospital that does conduct clinical trials, or that an experienced investigator is affiliated with that hospital."

Plack and Zach Henderson, VP, marketing and product development for Health Market Science, acknowledged that physician information can be accessed and utilized from a variety of shapes, forms, and sources, including Google, silos of data within a company, internal and external databases, and more. "But this is a more scientific approach," explained Plack. "By integrating our accurate and timely masterfile data with known claims experience and trial detail, we provide a solution for a more centralized and efficient process."

The data utilized in Clinical Investigators is for U.S.-based site selection. It contains data for over 650,000 physicians and over 6500 hospitals.

Global trials and overseas site selection are yet additional factors in subject recruitment and clinical trials conduct in general. "The shift to overseas is a function of many things," Plack told Applied Clinical Trials. "These include greater selectivity of U.S.-based PIs and access to larger patient populations. The level of detail we provide about U.S.-based sites is not widely available for international trials, other than within the sponsors. It's very limited."

Clinical Investigators was formally launched earlier this year on July 14. Henderson said that clients have been using the tool prior to launch, and were instrumental in the designing and refining of the final product. —Lisa Henderson