‘Site-less’ clinical trials become more feasible

Conventional clinical trials involve the drug sponsor, the principal investigators’ sites, and the trial patients. Now, Center Point Clinical Research (Minnetonka, MN) is bidding to remove the PI site requirement by having trial materials delivered directly to the patient, and a combined online and telemedicine interaction with the trial patients. In principle, the practice can cut trial administration costs, retain patients better for the duration of the trial, and improve clinical quality, says Joe Martinez, Center Point CEO.

Center Point has already been offering a branded service, the Clinical Trial Research Pharmacist (CTRP) solution, which offers a network of pharmacists nationally (and soon, internationally) to interact with patients in a trial; this has been used for a number of nutriceutical trials, as well as a handful of pharma trials, including one that led to FDA approval of a product. Now, says Martinez, the company is combining CTRP with health teams and trial management services to become, in effect, a full-fledged clinical research organization. The concept works best with trials that involve a lesser amount of onsite lab tests, such as those involving patient-reported outcomes for quality of life or related criteria. “The big difference is that by minimizing site visits, trial sponsors can obtain better patient retention, since the trial patient does not need to make repeated site visits, which can be time-consuming, difficult and expensive,” says Martinez. With frequent patient interaction build into the trial administration process, better data quality can be obtained and the trial more closely monitored. With newly commercialized wearable devices for medical monitoring, even pharmacological data can be obtained. (Another newly developed feature of the site-less service, he says, is to add geofencing, so that if a trial patient does extended travel, that changed status can automatically be detected.)

Center Point is partnering with an established clinical trial supply company, Clinical Supplies Management of Fargo, ND—and that company, in turn, has recently been acquired by a Great Point Partners, a Greenwich, CT private equity firm, and has acquired Theorem Clinical Research, a Frankfurt, Germany clinical supply company. CSM provides customized clinical trial labeling and packaging along with logistics services.

Direct-to-patient clinical trials have been performed by a variety of trial sponsors, notably Pfizer’s REMOTE trial that started in 2011, with mixed results constrained by the ability to qualify trial participants while collecting useful data. With the improved communication technologies available today, Center Point hopes to bring a new business model to the clinical research process.