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Genentech’s Patient-Centric Approach to Clinical Trials

February 10, 2016

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As clinical trials are becoming a focus of health concerns in the upcoming push for medical advancements, certain negative aspects are unable to escape from the public eye. The lack of released trial information has been exposed by the press, as has the apparent lack of demographic diversity of recruited patients. In order to push for an effort to become more patient-friendly in their studies, Genentech has made patient-centricity a major point in their recruiting strategy.

Late last October, Genentech announced their new model for the patient-centric approach, with Joling Mew saying, “it is a model that puts the patient at the center of the trial, and its success relies on the patients partnering with us,” she says. “Almost everyone, at one time or another, has gone online to search for healthrelated information. Most everyone also considers their primary care physician to be a trusted partner for managing their health. Both of those factors are relevant to the model we are testing.”

Currently, the investigator-centric model consumes too much time, especially on identifying and qualifying the trial sites. Instead of focusing on the patient population, the sites are first identified, then later moving along with patient enrollment. Mew pointed out that the novel approach would be to locate the patient first and then locate an appropriate site, instead of the traditional site-first, then recruitment approach.

Technology’s Place in Patient-Centric Recruitment

As the presence of basic biosensors and mobile platforms increase, so does the reach of clinical trial sponsors. The strategy of locating the patient first and then the site would prove to be not as a smooth-flowing process as one would’ve hoped, so the next targeted approach builds off that theme.

The process begins with a principal investigator (PI), who then oversees the accountability and treatment decisions of the patient. Within that scope, patients are recruited through their local physicians’ and local networks’ digital platforms. Once they have expressed an interested and engaged with their physician, their local healthcare system goes through the approval process. This overall progression simplifies the ease in which the patient is enrolled, in opposition to the site-first approach.

The PIVOT Study

Genentech’s Patientcentric Innovative Vision hOme Testing (PIVOT) study is currently targeting patients with diabetic macular edema (DME) or age-related macular degeneration (AMD) using the mobile platform recruitment process. There are two arms being tested: one with the patient-centric recruitment through digital media like Facebook, Twitter or LinkedIn, the second with the investigator recruiting from his existing patient population based on eligibility with his staff then guiding through the qualification process.

Because the patient-doctor contact would be limited in a patient-centric mobile recruiting approach, Mew stated that the importance of relaying all and any sort of relevant information was made clearer in the first arm of the study. Genentech also accounted for the issue of physicians being willing to support patients outside of the investigational site, since the mobile approach would not have a standardized location for patients to check in. Ophthalmologists were surveyed and asked if they would be willing to provide information to such mobile patients, resulting with a vast majority supporting this method in patient recruitment.

 

Enroll Your Clinical Trial On-Time and Efficiently By Contacting RESolutions, LLC Today!

By targeting patient populations relevant to your clinical trial, RESolutions, LLC is dedicated to patient recruitment so that you may enroll your trial on-time and on-budget. If you would like to learn more about our services or would like to speak with a representative directly, Contact Us today!

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