The ‘site-less’ clinical trial process moves ahead

A Minnetonka, MN company, Center Point Clinical Services, has been promoting the concept of a “site-less” clinical trial: test materials are shipped directly to patients’ homes, and both principal investigators and “clinical trial research pharmacists” (CTRPs, trained and certified by the company) intervene as necessary during the course of the trial.

Now, in an article published in the J. of Clinical Therapeutics (April 2017, vol. 38, no. 3), the company president, Joe Martinez, details the results of this program in 12 clinical trials involving two non-insulin glucose lowering medications. Pharmacists called enrolled study participants at specific time points during the trials and were available 24/7 to receive patient calls for most trials—and this was used by patients more than 25,000 times during the course of the trials, with most of the interventions characterized as “high impact.” The result of the program was “better patient compliance, outcomes and ultimately, more reliable and robust study results,” says Martinez.