Janssen, Syneos Health, IACT Health: Collaboration in Clinical Trials

This video provides an in-depth exploration of the critical collaboration challenges facing the clinical trial ecosystem, featuring perspectives from major industry players like Janssen, Syneos Health, and IACT Health, and hosted by Veeva Systems. The central theme articulated by the speaker is the pervasive and destructive "us versus them" mentality that hinders efficiency and progress across the life sciences sector. This adversarial mindset is not limited to the relationship between sponsors and their external partners (Contract Research Organizations or CROs, and clinical sites) but often exists internally within large pharmaceutical organizations themselves.

The speaker highlights that the current operational environment is characterized by a lack of a shared vision and a failure to prioritize mutual success. Stakeholders operate from a position of individual need, constantly stating "I need more questions to evaluate this patient clinically," or "I need more technologies because this is what I think is going to suit my needs the best." This self-centered approach supplants the necessary collective focus on "we need." Consequently, sponsors fail to seek understanding regarding what sites require to be most effective, what CRO partners need to execute efficiently, and fundamentally, what patients need to ensure successful trial participation.

A significant portion of the analysis focuses on the consequences of this siloed thinking. When sponsors complain that CRO partners "just don't understand," the speaker challenges them to consider what proactive steps were taken to provide that necessary vision or context. Similarly, when sites are perceived as failing to prioritize a sponsor’s clinical trials, the speaker suggests that the fault lies with the sponsor for not making the trial easier—through simpler contracts, streamlined budgets, or reduced administrative burden—to encourage site engagement. The ultimate solution proposed is the adoption of a common vision driven by the patient, which should serve as the unifying force for all parties. However, the speaker concludes that the industry currently lacks the "great tools" necessary to bridge these organizational divides, overcome individual points of view, and foster true collaborative success.

Key Takeaways:

• Systemic Collaboration Failure: The clinical trial environment is plagued by a deep-seated "us versus them" mentality, which exists between sponsors, CROs, and sites, and even within different departments of a single large pharmaceutical company.
• Prioritization of Individual Needs: Stakeholders, particularly sponsors, tend to focus on their own requirements ("I need, I need, I need"—e.g., more data, specific technologies) rather than adopting a collective "we need" perspective centered on partner success.
• Lack of Shared Vision for CROs: Sponsors frequently lament that their CRO partners "just don't understand" the trial objectives or context, yet they often fail to actively provide the necessary vision, training, or integrated systems required for effective partnership.
• Site Engagement Barriers: Clinical sites often fail to prioritize specific trials because sponsors have not made the process easy; this includes overly complex contracts, cumbersome budgets, and unnecessary administrative complexity that hinders rapid activation and patient enrollment.
• Patient-Centric Unification: The patient should serve as the singular, common vision that drives all stakeholders—sponsors, CROs, and sites—to align their efforts and overcome organizational friction.
• Need for Operational Simplification: To improve site engagement and trial velocity, sponsors must actively simplify their processes, including making contracts simpler, budgets easier to approve, and overall trial execution less burdensome for site staff.
• Technology Gap in Collaboration: The industry currently lacks robust, integrated tools capable of bridging the communication and operational divides between disparate organizations, preventing the establishment of a single, unified workflow.
• Sponsor Accountability for Partner Success: Sponsors must shift their mindset from demanding compliance to enabling success, recognizing that the effectiveness of CROs and sites is a direct reflection of the support, clarity, and ease of execution provided by the sponsor.
• Internal Silos Hinder External Collaboration: The "us versus them" dynamic starts internally within large pharma organizations, suggesting that internal process optimization and data sharing are prerequisites for successful external partnerships.

Key Concepts:

• Us Versus Them Mentality: A pervasive siloed approach in clinical research where different stakeholders (e.g., Sponsor vs. CRO, Sponsor vs. Site) view each other as adversaries or separate entities with conflicting goals, rather than partners working toward a common objective.
• Common Vision: The concept that all parties involved in a clinical trial—driven by the ultimate goal of patient benefit and successful research—should align their individual objectives and processes under a single, shared purpose.