Sanofi Reaping Rewards Of Site- And Patient-Centric Clinical Development
By Deborah Borfitz
April 14, 2021 | Sanofi has succeeded in accelerating its clinical development timeline year over year, in large part by viewing patients as customers and key opinion leaders (KOLs), according to Victoria DiBiaso, vice president and regional head of the clinical studies unit in Asia Pacific, Eurasia, Middle East, and Africa. “What that means for patients is that we are developing meaningful healthcare solutions that are addressing unmet needs and we are doing it faster.”
DiBiaso was presenting on Sanofi’s “one team” model for developing medicines at the recent Summit for Clinical Ops Executives (SCOPE). She was joined by Megan Heath, who serves in the same capacity in Europe.
One critical element of the company’s collaborative approach is to engage patients and sites as advisors early on and applying their input to decision-making activities, says DiBiaso. “Listening is intentional” and happens with “EngageMEANT.”
Consideration is given to real-world factors such as standards of care and the preferences of patients, she continues. Disease-related experiences impact treatment adherence, which translates to the clinical trial space.
Patients as well as future prescribers and payers are looking for “meaningful solutions” and care about the profile and tolerability of investigational products, DiBiasi says. Trials also need to be purposively inclusive of the populations the company is trying to help, she adds.
Another component of the Sanofi model is to “find solutions together,” says DiBiasi, including innovations for patient-centric trials and operational strategies for reducing burdens on site staff. Sanofi, trial sites, and patient communities are on the same team and communicate openly and transparently.
The patient-centered part of Sanofi R&D includes a fully dedicated team that is “focused on informing research all the way back to discovery as well as development teams about the relevant patient insights that we need to listen to and then translate into actions,” says DiBiasi. This includes both qualitative and quantitative data from direct advisory activities with patient advocacy organizations, modeling and simulation of real-world data, and the use of patient-generated health data to uncover patterns and decision-making that happens at home between physician visits.
In addition to looking at literature, she adds, the team works with behavioral science experts to understand “some of the why that goes into patient decision-making.” Patients are treated as the key opinion leader because “no one knows better how to live with a disease than someone who does.” They are therefore the key customer group and expert in helping Sanofi define a lot of its priorities.
Patients today are taking a much more informed approach to selecting treatments as well as sharing their views with physicians, regulators, and payers about how their unmet needs should be prioritized, DiBiasi says. “In essence, they are shaping standards of care, and they are also feeding into a lot of healthcare policies.”
Being on the same team, she says, “we need to have the same lens.” Sanofi therefore seeks to understand patients and the concerns of subpopulations to address barriers to treatment. It also works to ensure outcome measures are relevant to patients, trials are designed to be patient-centered, and digital innovations are utilized so studies become more a part of patients’ normal daily life.
Patients and advocacy groups are consulted on solutions for recruitment, retention, awareness about research, supporting patient educational opportunities, and examining different risk-benefit scenarios within the development of a clinical program, says DiBiasi. “We have also aligned our understanding of what it means to be patient-centric within R&D so that we are all working toward the same expectations.”
As part of its commitment to active listening, Sanofi launched a program called SMILE (Sanofi Making Investigator Life Easier). It focused on five key areas—protocol optimization, finance and contracts, site partnership and holistic patient recruitment, empowering clinical research associates (CRAs), and overall study support—based on what investigators identified as being particularly burdensome, says Heath.
Protocol optimization is attempting to accommodate patient and investigator needs in studies and allowing them to “pressure test” protocols, she says. Digital tools and electronic data are being used to align inclusion and exclusion criteria and minimize the burden on investigators.
Sanofi also transformed its payment process with sites. “We’ve moved to having a 30-day pay policy and no holdback in our contracts, so investigators are paid on time and do not have any blocks on payments, which helps support their business and partnership with us.”
The company has a strong site partnership network to support recruitment, Heath says, and has been as transparent as possible about its portfolio, start times, and recruitment rates. It also has an industry-leading partnership with CRAs following the FSP (functional service provider) model that has made them “the voice of Sanofi” at sites. Empowering CRAs to answer queries from site staff has shortened response time.
Sites can “pressure-test” Sanofi-issued case report forms, and the company has also used their comments to reduce and improve the query process, says Heath. With their input, investigator meetings have become “more agile, engaging, and meaningful” for both investigators and site teams.
The SMILE program helped Sanofi earn the No. 1 spot in overall reputation among sites in a 2019 CenterWatch survey, Heath says. In addition to improving its excellence rating across all areas of focus, the company did better on low-scoring attributes.
When the pandemic hit, Sanofi already had a true (not remote) risk-based monitoring process in place and reduced the level of source document verification being done in studies, limiting the amount of time sites were spending on calls, says Heath. It also already had direct-to-patient shipment of investigational medicinal product and home nursing options set up.
The rapid payment policy has been “meaningful and beneficial” to sites struggling during the pandemic to keep the cash flow going, Heath adds.
In addition to SMILE, Sanofi has launched an ambitious ACT4Patients initiative to “reshape our clinical trials in a new ecosystem” so studies can be offered to patients at home, Heath says. The design and delivery of trials will be improved using digital tools and approaches.