Contract research organizations (CROs) must constantly stay abreast of key pharma and biopharma trends while at the same time address current market challenges and make hard decisions about what capabilities are needed for today’s complex clinical trials. 

Kort Schickfus, Chief Business Officer, Research & Development Solutions, IQVIA, shares his thoughts with Contract Pharma.

Contract Pharma: What key pharma and biopharma R&D trends are impacting outsourcing and services?

Kort Schickfus: The drug development landscape is continually becoming more complex and pharmaceutical and biopharma companies recognize the need to evolve their business and meet these challenges at a rapid pace. Whether it is protocol assessment and design, technology integration, partner/vendor management or evolving regulatory requirements, trial sponsors want to ensure investments deliver maximum potential. Global macroeconomic impacts are weighing on them too, and so trial sponsors are simultaneously streamlining their clinical efforts while maintaining patient safety and high-quality data outputs. Enhanced patient-centered approaches and diversity in their trials are top of mind as well. While the focus on patients continues, sponsors also have to support sites, especially in navigating through staffing challenges and simplifying the tech-enabled tools and resources provided to conduct today’s trials.
 
Ultimately, these multiple challenges require “doing more with less” and selecting the right clinical research organization partners to optimize the work. Our goal, as a partner, is to simplify the evolving complexities within today’s trials with varied yet tailored end-to-end services.

Regardless of the trial sponsor’s operational model, full-service, hybrid or functional service provider, the core fundamentals of therapeutic knowledge, strong trial management capabilities and supporting technology all remain critical to outcome success as does the increasing need for the optimal integration of their CRO partner capabilities.

Contract Pharma: What capabilities are needed for today’s complex clinical trials?

Kort Schickfus: To effectively meet the demands of today’s trials, it is critical for sponsors, their CRO partners and study teams to consider the needs of all stakeholders early in the process. As sponsors aim to optimize investments while reducing patient and site burdens, there is piqued interest in several notable capabilities:

• Trial intelligence and prioritization: Sponsors and CROs are doing more planning work upfront, leveraging an extensive breadth of data available through electronic health records, claims data, trial registries and more to fine-tune tech-enabled solutions, including artificial intelligence and machine learning models, for increased predictability in study planning and asset development. From protocol design through enrollment strategies, sponsors are securing meaningful insights to guide their business strategy, shedding light on impact in terms of cost, timelines and site and patient experiences. For example, in training ML models to learn to use trial protocol details, site features, previous performance, patient demographics at sites and more, sponsors can better pinpoint   target sites that are more likely to have faster study start-up and help improve diversity simultaneously. 

• Data-informed protocol assessment: To ensure better trial participation and engagement among underserved patient populations, calculating patient burden using qualitative data from patient insights can help sponsors and CROs gauge motivation to participate by race and ethnicity and the impact of various trial design elements. Understanding willingness to participate per cultural needs and wants can help achieve sponsor diversity goals and reduce potential protocol amendments.

• Direct-to-patient recruitment: Supporting sites in the recruitment process, sponsors are also leveraging real-world data to identify patients of interest and targeting engagement through fine-tuned direct-to-patient advertising, marketing materials, recruiting campaigns and community outreach that can be adjusted in real-time. Through click-of-the-mouse sign-up opportunities via user-friendly platforms, if participants met trial criteria, they can be instantly matched to an active site, confirm the initial visit time and reach site staff quickly.

• Clinical trial educators: Involving trained clinical trial educators (i.e., registered nurses, therapists, pharmacists, educators, etc.) in trial design can improve patient engagement strategies. For sites challenged to achieve enrollment targets, these specialists can share successful enrollment techniques while simultaneously leveraging their own referral networks to reach more patients for the site and educate additional sites on studies of interest. Just as critical, CTEs can also be in lock step with patients and caregivers, providing them with educational information regarding the studied therapy and trial process to strengthen motivation for engagement. CTE’s experience in community outreach can be key to reaching diverse patient populations as well.

• Site management and support: Recognizing site needs will vary, CROs like IQVIA are offering scalable site management support and services as part of comprehensive site network solutions to ensure study start-up timelines, data quality and patient recruitment are optimized to meet sponsor goals and specifically lower the burden on sites. These site network solutions can also help sites ensure sufficient representation among those most impacted by the studied disease or condition are prioritized in patient recruitment strategies.

• Connected devices and digitized data collection: Clinical trials now capture three times as much data as they did a decade ago, given the growing number of data sources involved. The increasing use of connected devices and wearables is helping to provide patients with the flexibility they need to participate in trials while allowing sponsors and study teams to dive deeper into patient behavioral trends, securing richer insights in near real-time to guide informed decision-making. Given the massive amount of data coming in from these sources, having a comprehensive digitized data management strategy with automation of data flow, from collection to cleaning and transfers and continuous data oversight is essential. For site teams, burdens of manual review and related administrative tasks can be reduced to allow their focus to remain on quality care.

• Clinical lab services: Biotechs leading the path to innovative personalized medicine, including cell and gene therapeutics, turn to multiple service partners to secure the right expertise and solutions for trial programs. To avoid overloading in-house resources and teams and creating unnecessary inefficiencies, these sponsors are looking for CROs to seamlessly work with or have scalable lab services to interconnect expertise and solutions and maximize trial programs. Understanding therapeutic nuances within target patient populations and complex science-driven treatments that require solutions, such as next-generation sequencing, digital pathology, biomarker development and more, biotechs are looking for heightened clinical and operational collaboration among CROs and lab services to ensure they can refocus on their long-term strategy and related goals.