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 of 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 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 are great places to start. By having visibility into patient 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.
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