Running a clinical study entails significant costs and necessitates collaboration among sponsors, vendors, CROs, and sites to ensure trial success.
At the 13th Annual Clinical Trials in Oncology East Coast 2024 conference in Burlington, Massachusetts, panelists discussed the factors influencing effective outsourcing strategies. Claudia Hesselmann, founder and CEO of ARENSIA Exploratory Medicine, emphasized that while post-pandemic inflation has impacted trial costs, the key determinants of budget remain the protocols, procedures, product complexity, and human resources required for the study. She noted that bureaucratic inefficiencies often contribute to increased costs rather than these essential variables.
Kevin Stephenson, Executive Director of Data Management at Karyopharm Therapeutics, highlighted the importance of operational efficiency and cost-effectiveness through thorough planning, appropriate feasibility processes, effective patient visibility strategies, and strong site relationships. He stressed the importance of prioritizing essential processes for decision-making and data collection, emphasizing the need to distinguish between necessities and preferences.
David Sherris, PhD, Board of Director at SiVEC Biotechnologies, underscored the necessity for early-stage companies to have a clear understanding of their resources and financial capabilities. He emphasized that establishing trust between CROs and sponsors is crucial for success.
Regarding partnerships between vendors and sponsors, Stephenson emphasized the significance of direct communication to understand the true value a vendor can bring beyond their stated qualifications. Sherris added that vendors should be evaluated individually to assess their suitability for specific sites.
In summary, the discussions highlighted the complexities of managing clinical trial costs, the importance of efficient planning and partnership dynamics, and the need for clear communication and trust among all stakeholders involved.
