Merck on Investigator-Initiated Studies and Budgeting Practices at 2025 SCOPE Summit

The 2025 SCOPE Summit’s panel discussion on investigator-initiated studies (IIS) delved into the complexities of budgeting practices, highlighting the growing importance of IIS in clinical research. Industry experts Meghan Harrington, Karen Hartman, and Michael Salvatore Jr. explored the nuances of IIS, the challenges in budgeting, and the collaborative efforts needed to streamline processes. Understanding their role and optimizing financial management becomes crucial for advancing scientific research and patient care as IIS gain traction.

Understanding Investigator-Initiated Studies

IISs are pivotal in clinical research, with the investigator or PI at a site taking the lead in initiating and managing the study. Meghan Harrington from Medidata explained that in IIS, the investigator assumes regulatory responsibilities, while industry partners provide financial support and necessary investigational products. This distinction is crucial as it differentiates IIS from collaborative research, where industry partners like Merck might have a more significant role in shaping the scientific objectives and conducting the trial. Karen Hartman from Mayo Clinic added that from a site perspective, the lines between different types of research can blur, emphasizing the need for clear definitions to ensure all parties have a mutual understanding of their roles and responsibilities. Michael Salvatore from Merck highlighted that when a study becomes collaborative, it shifts from being investigator-initiated to a joint effort, with the company having a say in the protocol and trial conduct. This nuanced understanding of IIS is essential for effective collaboration and successful study outcomes.

The Growth and Value of IIS

The panelists observed a notable increase in the number of IIS over the past decade, with many companies establishing dedicated IIS management offices and submission portals. Michael Salvatore shared that Merck has experienced a significant rise in submissions, particularly after the success of a popular product, which led to thousands of submissions per cycle. This growth reflects a broader industry trend where IIS are increasingly recognized for their scientific value. At Merck, IIS are seen as a means to contribute to the scientific literature and explore research avenues that the company might not pursue internally. This approach allows Merck to support trials that could provide critical treatment options for patients, especially in niche areas. Karen Hartman emphasized that IIS are integral to their research objectives at Mayo Clinic, with about 40% of their active clinical trials being investigator-initiated. These studies offer opportunities for junior and senior researchers to innovate and advance science, often providing potential patient care options through protocols tailored to specific patient populations.

Budgeting Challenges and Opportunities

Budgeting for IIS presents unique challenges, as initial estimates often evolve as protocols are refined. Karen Hartman noted that draft budgets based on preliminary protocols can differ significantly from final budgets, particularly when additional tests and procedures are incorporated. This discrepancy can lead to delays and complications in the budgeting process. To address these challenges, the panelists highlighted the importance of engaging researchers and a centralized approach to budgeting. Michael Salvatore explained that Merck has adopted a phased approach to budget submissions, starting with a feasibility assessment before requesting a detailed proposal. This strategy has reduced approval times and improved efficiency by allowing Merck to focus on the scientific merit of proposals before delving into detailed budget negotiations. The panelists agreed that communication and coordination between PIs and budgeting offices are crucial to avoid delays and ensure accurate budget estimates.

Evaluating and Collaborating with Sites

Merck employs a rigorous evaluation process for IIS submissions, assessing the scientific rationale, institutional capabilities, and feasibility of proposed studies. Michael Salvatore described this process as similar to an NIH-style scoring system, which helps Merck objectively prioritize studies that align with their strategic objectives. This evaluation considers the institution’s track record, the scientific soundness of the proposal, and the feasibility of conducting the study within the proposed timelines. The panelists discussed the importance of transparency and communication between sponsors and sites to ensure successful collaboration. Karen Hartman emphasized the need for coordination between PIs and budgeting offices to avoid discrepancies in budget estimates and ensure that all parties clearly understand the study’s requirements. This collaborative approach is essential for overcoming challenges and maximizing the potential of IIS to contribute to scientific knowledge and patient care.

Streamlining Budget Assessment with Technology

Merck and Medidata have collaborated to streamline the budget assessment process for IIS and to develop standardized budget templates and leverage predictive analytics. This initiative aims to modernize data and provide fair market value assessments, reducing the back-and-forth negotiations between sponsors and sites. Michael Salvatore shared the challenges of dealing with diverse budget formats from various institutions, which previously slowed down the approval process. By adopting a formalized template, Merck has alleviated bottlenecks and improved efficiency in budget assessments. Medidata’s efforts to incorporate real-time data, inflation adjustments, and country-specific ratios into their site payments application have further enhanced the accuracy and fairness of budget negotiations. This technological advancement reflects a broader industry trend toward using data-driven insights to optimize clinical trial processes and ensure that budget negotiations start from a fair and informed position.

Summary

The insights from the 2025 SCOPE Summit highlight the growing importance of investigator-initiated studies in the clinical research landscape. By addressing budgeting challenges and fostering collaboration between sponsors and sites, the industry can enhance the efficiency and impact of IIS, ultimately advancing scientific knowledge and patient care. As IIS continues to gain traction, the lessons learned from this summit will be instrumental in shaping future practices and policies in clinical research.