Clinical Trial Financial Management: Financial Effects of Site & Patient Burden

The Clinical Financial Blog series was created to address the complexities that are encountered with the financial management of clinical trials. With a lot of critical financial requirements still not fully understood and addressed, we’ve got you covered. Medidata’s team of experts, who have lived and breathed the budgeting and site payments processes, will provide first-hand experiences, sharing knowledge and recommendations they’ve built over many years of direct experience with sponsors, CROs, and sites. This month’s topic covers clinical trial site burden and patient burden, as well as the financial downstream effects.

We have all heard that COVID-19 has produced numerous changes for patients and sites, including psychological distress, workforce shortages, overall economic impacts, and varying comfort levels related to healthcare. We must understand the potential risks and burdens for patients and sites caused not only by these global influences but also by the personal circumstances that research participants experience. Understanding burdens to sites and patients visually lets the industry budget accordingly and plan for preventative and protective measures. 

There are many factors that contribute to patient burden, site burden, or both, so it is necessary to understand these influences and predict their financial impact. As Dr. Joel Ebuh, CEO and Site Director, Gadolin Research states, "as we observe the surge in gas prices, we must recognize that our industry will not be immune to sustained inflationary pressures. We should anticipate the increased opportunity cost for research participants could lower study enrollment and retention rates."

Meet Clinical Trial Patients Where They Are

Sponsors, sites, and technology providers are responsible for encouraging the industry to collaborate and develop effective ways to meet patients where they are. In addition to the obvious items in the protocol, the cost to patients for things like taking time off of work and providing daycare for their children needs to be understood and compensated accordingly.

Research patients are, firstly, humans who thrive on being cared for and heard. As organizations in research and healthcare, our intention is not only to recruit participants but also to retain those clinical trial patients throughout the study duration. The concept of patient burden as it relates to study budgets lets us maintain a mindset of patient-centricity, from the earliest stages of financial planning.

Focus Clinical Trial Sites on Patient Care, Not Administrative Tasks

It is imperative to support the allocation of additional budget to serve clinical trial patients better and fund sites appropriately. We have found that administrative tasks slow down study progression and often are the source of dissension between sponsors and sites. Reduce the guesswork and let sponsors create fair and appropriate budgets upfront by having visibility into the patient and site burden values. Presenting a valid budget to a site—in which you’ve properly considered the effort that a study will consume—can decrease the time and rounds of negotiation, and eliminate tension that arises in the negotiation process.

It is essential that sponsors, CROs, technology providers, and sites partner to increase awareness of each party’s experience and therefore understand the goals of everyone involved. Indeed, the study and site budget is a great place to start. By having visibility into patient burden and site burden, the industry can look at the budget from all angles and understand how that protocol and the world around us affect every aspect of the patients being served.

Watch our Clinical Finance Video Series to learn more about clinical trial financial management.

About the Authors:

Shelley Douros, Senior Director of Product, Clinical Trial Financial Management

Shelley Douros is Senior Director of Product at Medidata, a Dassault Systèmes company, focusing on clinical trial planning and budgeting. She has over 20 years of experience dedicated to cross-functional collaborations specific to clinical trial budgeting and forecasting, business operations, outsourcing, and investigator budget development and negotiations. Shelley has spearheaded the creation of financial lifecycle platforms for both sites and sponsors. She has served as a speaker and chair at numerous industry conferences and has authored many published articles. Shelley has a passion for uncovering pain points and identifying strategic solutions that lead to faster, effective, and mindful patient care.

Michelle Schiripo, Solution Consultant

Michelle Schiripo is a Solution Consultant at Medidata, with an industry background in clinical operations and study monitoring. She has first-hand experience with the utilization of clinical research technology, and a talent for understanding the complexities and nuances of clinical study execution. Since joining Medidata, Michelle functions as a trusted technological advisor, providing product expertise across the Medidata Clinical Cloud®.