Gatherings of representatives from clinical trial sponsors and sites aren’t always inspiring or uplifting, but don’t tell that to Victoria DiBiaso, from Clinical Sciences & Operations in Sanofi’s R&D organization.
“We had a global meeting [in early June] with approximately 30 sites from around the world that are part of our site partnerships program,” recounts DiBiaso. “During this symposium we updated them on our SMILE initiative and they gave us exactly the same feedback: ‘No other sponsor is doing this. Thank you.’” SMILE is a global optimization of how Sanofi conducts its clinical trials to reduce the burden on sites and patients, and it stands for Sanofi: Making Investigator Lives Easier.
Launched in 2017, the “whole objective [of SMILE] was to positively innovate the way we conduct our clinical trials from a site-centric perspective,” DiBiaso says. Before kicking off the program, though, Sanofi took time to really look at clinical trial efficiencies with an eye toward improving them from the perspective of reducing the burden of clinical research to make it easier for sites and patients to contribute to a greater extent.
“We have some extremely beneficial programs [that might ultimately] address true unmet medical needs for patients,” especially in the arenas of oncology and rare blood and genetic disorders, DiBiaso says. “It is our ethical obligation to run these studies faster so that [the end result] is either life-saving or improves quality of life,” she adds.
After analyzing clinical trial site feedback with an assist from CenterWatch’s Global Site Survey, Sanofi came away with a better understanding of five key areas of focus—ranging from protocol optimization through to clinical research associate (CRA) quality and empowerment. It also includes Site Partnerships and Holistic Patient Recruitment, Contracting, and Financing processes, plus overall study support, which among other factors looks at sites’ data query processes and case report form standards.
From the perspective of supporting the role of the CRA, “we hear from sites that having a well-trained CRA who is knowledgeable in study design” is of vital importance to study conduct, DiBiaso says. By bolstering training and other programs, Sanofi today enjoys a CRA workforce with levels of turnover that are declining. They hope to have data soon to demonstrate it’s also improving CRA training and job satisfaction on Sanofi studies.
DiBiaso and team were also “thrilled” last year to be among the pharmaceutical companies included in the ACRP-Avoca Awards and Recognition Ceremony spotlighting innovative work by sponsors and others, she says. Sanofi placed second in a competition involving sponsors and contract research organizations. “A lot of the elements that were voted on were relative to what we’re doing in SMILE,” DiBiaso adds.
“For us, that was like the biggest congratulations and acknowledgement that we’re going in the right direction,” DiBiaso says, “so thanks for ACRP on that front.”
Author: Michael Causey