The design of a study’s protocol is pivotal to its success in clinical trials, and engaging study sites early in this process can significantly enhance outcomes. In this interview, we sit down with Chris Herrick, VP for Research Systems and Technology at Mass General Brigham, a leading academic healthcare system based in Boston, United States, to discuss the importance of site involvement, the challenges of exclusion, and the potential for improved trial success through collaboration.
Moe: What challenges arise when sites aren’t involved in protocol design?
Chris Herrick: The absence of site involvement results in inconsistency and shared burdens between sponsors and sites. There’s substantial variation in how protocols are handled, ranging from legal contracts to Institutional Review Board (IRB) processing and budgeting. Without a standardized process, sponsors encounter complex collaboration and prolonged negotiations, sometimes lasting a year and a half. This inconsistency hinders sites from utilizing their expertise to anticipate and address potential obstacles, ultimately impacting the trial’s efficiency and success.
For instance, Mass General Brigham conducted a study on a chronic disease where the protocol’s timeline for diagnosis was unrealistic. This significantly reduced the eligible patient population. By amending the protocol to align with realistic diagnosis timelines, we increased the number of patients we could recruit. This demonstrated the crucial role of site input. This adjustment resulted in an overall increase in patient recruitment, illustrating how early site involvement can effectively address workflow issues. By incorporating site insights during the protocol design phase, sponsors can avoid similar challenges and enhance the overall success of their clinical trials.
Moe: How might protocol amendments change with early site involvement?
Chris Herrick: Protocol amendments are costly, averaging around $500,000 per amendment. Involving subject matter experts and using real-world data early on can reduce the need for amendments. By addressing potential issues upfront, sponsors can avoid costly changes and improve patient enrollment. For example, when Mass General Brigham experts reviewed a protocol and suggested changes, it increased patient recruitment and reduced the likelihood of future amendments. This proactive approach saves costs and enhances the overall efficiency and success of clinical trials by ensuring that protocols are well-designed from the outset.
Moe: Why are current real-world evidence (RWE) models flawed, and how does Mass General Brigham’s approach to RWE differ?
Chris Herrick: ICD-10 codes, often used for reimbursement, can misrepresent patient conditions, impacting trial accuracy. For example, a patient might be coded for diabetes to justify a glucose test, even if they don’t have the condition. This can lead to flawed analyses if trials rely solely on codified data. Real-world evidence (RWE) offers a richer, more accurate picture by incorporating diverse data types, including unstructured notes, biomarkers, and patient-reported outcomes. By integrating RWE, Mass General Brigham can build computed phenotypes that comprehensively view patient populations, enhancing trial design and success.
Moe: How can computed phenotypes improve patient identification in trials?
Chris Herrick: Using computed phenotypes, including various data types like codified data, unstructured notes, biomarkers, and imaging, allows for more accurate patient identification. This approach overcomes the limitations of codified data for reimbursement purposes, providing a richer, more accurate picture of patient populations. By leveraging this comprehensive data along with clinical validation through the electronic health record (EHR), we can build machine learning algorithms that accurately identify patient populations, ensuring trials start with the right participants and improve overall trial outcomes.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.