By Maxine Bookbinder

January 17, 2017 | Center Point Clinical Services, a contract research organization, launched what it calls “the world's first site-less, technology CRO,” designed to increase patient recruitment, engagement, and successful trial completions at lower cost.

“This is the evolution of in-home clinical trials,” says CEO Joe Martinez. “It is really a patient-based clinical research effort.” In place of on-site visits, patients work with collaborating health care professionals and sponsor company teams.

The site-less trial model is compliant with all federal regulatory standards. Every trial has at least one principal investigator who reviews all protocol particular to that study. However, says Martinez, “There is no large, faceless CRO. It reduces lag time and increases communication because we are available to identify patient issues and react in real time instead of 30 days later.”

Site-less studies allow residents to participate who live in remote areas or are unable to travel due to illness, injury, or other physical limitations. “Sponsor companies have wider options to screen for potential patients,” says Martinez. “We are removing the need to have a physical site.”

Martinez says site-less trial recruitment can be completed in 4-8 weeks. For example, in 7 studies, 764 people were enrolled in an average of 47 days.

In addition to medical professionals, pharmacists, advocacy associations, websites, and social media, recruitment relies on the Center Point Clinical Trial Research Pharmacists (CTRP), who know a study’s inclusion and exclusion criteria and can share it with potential patients. Sponsoring companies can bundle specific services through the CTRP, who then alert local pharmacists to different clinical trials. Center Point also filters health records through a HIPPA-compliant collaboration with pharmacies and health systems.

Site-less trials only recruit for one site instead of multiple; they operate remotely but coordinate with health care teams according to trial protocol. “There are no geographical barriers for patients who are interested in enrolling but are not close to a clinical site. Even though the name is ‘site-less’, the actual process is like having every patient next to a clinical site,” says Martinez, adding that this model is also successful in hybrid clinical sites, combining an on-site clinician with the virtual Center Point site and CTRP support.

Pharmacist Advantage

Center Point’s CTRP are trained to reach out and develop relationships with their patients and when appropriate, caregivers, through weekly conversations via phone, Skype, FaceTime or other technology, monitoring behavior and compliance and collecting data.

“Patients will often see multiple doctors,” says Martinez, “but will stick with one pharmacist, who usually knows his or her patients very well.” Information from wearable devices goes immediately into the cloud and then the study’s database. All information is confidential.

Martinez attributes these patient-pharmacist relationships, emphasizing protocol, compliance, and compassion, for increasing patient engagement. The CTRP “are the glue that hold everything together,” he says.

For example, in a study for a diabetic therapy, the pharmacist discovered during casual conversation that a patient ate Twinkies after every dosage, trying to measure his blood sugar level to determine whether he was assigned the placebo or test drug. In a different study, a patient took his medication at breakfast and dinner, as instructed. However, he ate dinner at noon and supper at night and therefore missed the designated 12 hour intervals. In both cases, the pharmacists “went into rapid response mode” with immediate interventions, says Martinez, which required re-educating the patients and retraining the clinical site staff.

These established relationships, says Martinez, quicken the pace of successful trial completion at up to 60% reduced cost. He says that more than 40% of the average costs originate in clinical site activities; multiple physician investigators add 6%, and administrative staff costs add another 20%. “Potentially $7 million of a typical $13.9 million clinical trial can be saved for use elsewhere to support the brand.”

In addition, Martinez says validating the clinical database can take only 6 days; Instead of multiple calls to multiple clinical sites to complete data identification, verification, review and analysis, site-less data are reviewed and analyzed and validated in real-time by Center Point’s algorithms. Any discrepancies are immediately addressed by the CTRP pharmacist. Data is in regulatory e-submission compliant format.

Site-less Advantage

Patients have two in-person office visits: at the beginning of the study—for a baseline physical exam, to authorize patient identification, and to review study procedures and protocol—and a final end-of-study visit. Blood draws, panels, and profile procedures during trials are performed in medical offices, labs, or at specified pharmacists contracted with Center Point to ensure all work follows specific standards. Patients must continue with the same service throughout the trial, which “knocks out about 92% of the variability,” says Martinez. Technology allows tests and data to be taken and analyzed within hours.

Medications are shipped directly from the sponsor company to the Center Point distribution warehouse and then to either a local pharmacist or the patient’s home, whichever is most appropriate. Bluetooth labels notify Center Point immediately if temperature-sensitive medications, labeled as such, have been compromised. Replacement medications are dispatched within 24 hours. “We can do cold-chain medications efficiently,” says Martinez. “The audit-trail is constantly monitored and data integrity is beyond reproach.”

Martinez says that data are more reliable and easier to validate because site-less trials avoid “the added steps of data input from multiple clinical sites and multiple clinical staff with varied amounts of clinical training.” He adds that the immediate electronic input of patient data by the CTRPs replaces paper forms from multiple sites, minimizing time spent recollecting and revalidating data collection and revamping stalled trials.

Center Point became an LLC in 2014 and has performed up to 10 site-less studies. Martinez says this model is good for “80 – 90%” of trials, but works particularly well for trials in which office visits are not needed or can be done remotely. It is also well-suited to neuro-degenerative diseases, such as ALS, Huntington’s, Parkinson’s, and Alzheimer’s diseases, because responses such as hand coordination movements, tapping tests, and verbal replies are easy to follow on webcams and microphones.

Site-less trials offer opportunities to patients with rare and orphan diseases, patients in studies that are lengthy or that monitor for cardiovascular events, such as in diabetes trials, or who are pediatric or elderly.

The site-less model has also enabled Center Point to rescue failing trials. “Patients get burned out with high-volume office visits that require travelling 50 miles a week just to get their blood taken and answer a couple of questions,” says Martinez, who attributes the flexibility of site-less trials to reduced patient drop-out rates.

Center Point is currently involved with several nutraceutical projects, including monitoring for metabolic syndrome in diabetes patients, reimbursement strategies for a global science company, and a new shingles therapy.