The Two Guiding Principles of Optimal Trial Delivery

By Rhonda Henry, Applied Clinical Trials

Clinical research, like raising children, often requires a village. It involves numerous stakeholders, from sponsors and sites to participants and vendors, all with their roles and responsibilities. With more players come complexities, but the fundamental principles of transparent communication and goal alignment remain vital for successful trial management. Trust-based relationships form the cornerstone, underpinned by early expectation setting, goal congruence, frequent communication, and a shared commitment to mitigating risks.

Credibility is a must in all business relationships. In sponsor-CRO collaborations, credibility-building starts in the proposal and bid defense stages. Commitments made during these early discussions set the stage for trial setup and execution. Sponsors choose CROs and vendors based on their perceived ability to deliver on these commitments. While there’s a temptation to present a rosy picture to secure the work, overpromising is risky and can erode credibility. Clinical research is inherently unpredictable, and aligning expectations and goals among stakeholders, with frequent progress assessments, facilitates early risk identification and collaborative recalibration.

Many sponsor-CRO relationships start with foundational assumptions about the scope of work, timelines, and costs. These assumptions should be rigorously tested, informed by data and experience, and refined to establish the collaboration’s baseline goals. Goals and milestones often have interdependencies. For instance, CROs depend on sponsors to provide the final protocol before site initiation, while sites need ethics committee approval and executed contracts to activate the study. Seemingly minor delays in any of these activities can lead to significant delays. Alignment on critical milestones and frequent progress reviews, therefore, enable early issue identification and timely resolution. Read more…