How Sanofi Incorporates Patient Data in Clinical Trials

At the recent Clinical Trial Outsourcing East Coast conference, Rachel Nering, Global Head of Early Development Clinical Operations at Sanofi, delivered a compelling presentation on the significance of Diversity, Equity, and Inclusion (DE&I) in oncology clinical trials. Nering provided valuable insights into integrating DE&I principles from the early stages of clinical development. Nering emphasized the historical context, current strategies, and future directions for ensuring inclusive clinical research.

The Importance of Patient Experience Data

Nering emphasized the importance of Patient Experience Data (PED) in Sanofi clinical trials, highlighting how it encompasses patients’ experiences, perspectives, needs, and priorities. The FDA’s guidance series (2020-2023) ensures that patient voices are integrated throughout the medical product lifecycle. For example, patient-centric trials prioritizing PEDs tend to recruit participants more quickly and have higher success rates. Data from the Economist Intelligence Unit shows that these trials are 20% more likely to lead to drug launches because they are designed with patient needs in mind, resulting in faster recruitment and higher retention rates.

Nering also highlighted the shared value of PEDs for patients and society. Trials that reflect real-world patient experiences produce more relevant patient data, especially in oncology, where treatment responses can vary across demographic groups. By considering PEDs, researchers can develop treatments tailored to diverse patient needs, leading to better health outcomes and equitable access to therapies. Additionally, early-stage patient engagement can yield significant economic benefits, with net present value increases of up to $62 million pre-phase 2 and $65 million pre-phase 3. This approach benefits patients and enhances the overall efficiency and success of Sanofi clinical trials.

Nering highlighted the critical role of Patient Experience Data (PED) in Sanofi clinical trials. PED includes patients’ experiences, perspectives, needs, and priorities, essential for informed medical product development and regulatory decision-making. She cited the FDA’s guidance series (2020-2023) to enhance the incorporation of the patient’s voice in medical product development. Patient-centric trials have a higher likelihood of success and expedite recruitment processes, as evidenced by the Economist Intelligence Unit data.

Quantifying DE&I in Clinical Trials

Nering’s presentation highlighted the importance of quantifying Diversity, Equity, and Inclusion (DE&I) within Sanofi clinical trials. She discussed a recent HealthMatch report identifying critical areas for improvement to ensure trials are accessible and inclusive. One primary challenge is the discoverability and reachability of trials. Many patients rely on their healthcare providers for information, but providers often lack comprehensive knowledge of all ongoing studies. Additionally, platforms like clinicaltrials.gov can be confusing, leading to uncertainty about eligibility. Geographical barriers further limit participation, with 70% of potential participants living more than two hours from the nearest study center, posing logistical challenges disproportionately affecting low-income and rural populations. For example, a rural cancer patient might struggle to participate in a trial requiring frequent city visits, limiting their access to treatments and skewing trial results.

Nering emphasized the need to consider time commitment, visit length, and scheduling to enhance accessibility. Trust is a significant issue, especially among African American communities, due to historical medical research abuses like the Tuskegee Syphilis Study. Building trust requires ongoing engagement, transparency, and culturally sensitive communication. Eligibility criteria often exclude diverse populations by focusing narrowly on medical attributes, overlooking socioeconomic, racial, and cultural factors. For instance, strict health insurance criteria might exclude minority populations without comprehensive coverage. The HealthMatch report revealed significant participation disparities, such as language barriers for Hispanic patients and lower trust levels among Black/African American patients. To address these challenges, Nering advocated for improving trial discoverability, reducing geographical barriers, enhancing accessibility, building trust, and broadening eligibility criteria to ensure more inclusive trials.

Translating Patient Insights into Actionable DE&I Strategies

Rachel Nering emphasized the importance of translating patient insights into actionable Diversity, Equity, and Inclusion (DE&I) strategies in clinical trials. Understanding patient priorities and the competitive landscape is crucial. For example, cancer patients might prioritize treatments with fewer side effects. Researchers can address unmet needs by analyzing existing treatments and emerging therapies and developing more targeted trials.

Nering advocated using the Clinical Outcomes Assessment (COA) to better understand patient experiences. COA includes Patient-Reported Outcomes (PRO), Observer-Reported Outcomes (ObsRO), Clinician-Reported Outcomes (ClinRO), and Performance-Based Outcomes (PerfO). In oncology trials, these measures help identify how different demographic groups respond to treatments, allowing for personalized approaches. For instance, if certain side effects are more common in a specific demographic, protocols can be adjusted to provide additional support. This approach ensures trials reflect real-world experiences and address the unique needs of diverse populations, promoting health equity.

Operationalizing DE&I Plans

Nering provided a detailed roadmap for operationalizing DE&I plans in clinical development. Key steps include:

• Patient Experience Narratives (PEN): Comprehensive summaries of epidemiology, demographics, health outcomes, and social determinants among racial and ethnic groups. These narratives help identify unmet needs and inform diversity plans, site selection, and recruitment strategies.

• Behavioral Science Integration: Analyzing behaviors and cultures of subpopulations to develop tools supporting diverse recruitment efforts. This approach helps identify potential recruitment and retention challenges and suggests proactive measures to mitigate them.
• Setting Diversity and Inclusion Goals: Establish recruitment goals based on the epidemiology of diseases in the US and refine these goals as protocols become available. This strategy ensures realistic and achievable recruitment targets early in the trial design process.

Summary

Rachel Nering’s presentation at the Clinical Trial Outsourcing East Coast conference highlighted the critical importance of integrating DE&I principles in oncology clinical trials. The clinical trial industry can ensure more inclusive and patient-centric research by leveraging historical insights, regulatory frameworks, and comprehensive DE&I strategies. This approach benefits patients and enhances the overall success and efficiency of clinical trials.