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P122: A Step in the Right Direction to Reduce Financial Burden of Clinical Study Participation: Patient Compensation Calculator

Poster Presenter

Makaelah Murray

Clinical Operations Lead
Genentech, A Member of the Roche Group
United States

Objectives

The objective is to assess if a more judicious approach to patient compensation helps eliminate financial burden faced by patients in clinical studies and therefore minimizes financial considerations as a reason to not enroll or go through with the entirety of a clinical study.

Method

Understand company policy on compensation, conduct a literature review on means to determine compensation, apply findings to internal procedures and produce a methodical approach to compensation. Utilize the calculator to determine the impact of a standardized approach to compensation.

Results

Financial burden is universal to patients and can be even more significant for those enrolled in clinical studies due to additional visits, testing, and loss of income due to being unable to remain employed or constantly missing days (Moy 2015). According to the Health and Human Services Secretary’s Advisory Committee on Human Research Protections, as long as a participant’s ability to adequately consider a study’s risks and burdens is not compromised, offers of payments should be considered appropriate. They define compensation as means to address the study participants’ time and effort/inconvenience due to study participation. US compensation amounts per visit before developing the calculator varied widely from $0-100 USD and were inconsistent internally – sometimes not even involving oncology patients. Specific aspects of study complexity were generally not taken into account, leading to a variance in payments to patients. We constructed this tool to equitize compensation amounts and in turn increase diversity in clinical studies through removing barriers to access. Following a framework derived from a review of the Oxford University Clinical Research Unit, we identified 9 factors specific to our clinical studies, representing varying degrees of complexity. Depending on how each of the 9 factors impacts the patient's visit, a point amount is tallied and multiplied by a dollar amount informed by the Economic Policy Institute as well as Genentech’s Patient Advocacy and Relations team. Currently, multiple US-based study teams have utilized the calculator and the average amount per visit is around $200. Feedback from a study site noted $75/visit was much lower than expected for a study which included invasive procedures and long study visits. Additionally, they noted typical compensation amounts from comparable studies ranged from $125-200. Study teams have reported these new compensation amounts have been approved by institutional review boards.

Conclusion

At Genentech, we are committed to addressing barriers to clinical study participation and advancing clinical research. We do not believe a clinical study’s population should only consist of those who can afford to participate. The social determinants of health should be a large consideration when enrolling representative patient populations in clinical studies as they are important factors which can inform the safety and efficacy of an investigational product. By reducing financial burden and therefore a barrier to clinical study enrollment and retention, advancements in medicine can be made, especially for those so often neglected by the field and more so pharma. By utilizing a tool like the patient compensation calculator, study teams are now able to take a more standardized and equitable approach to determining patient compensation values in early study planning. We plan to continually reiterate the tool based on feedback from study teams and beyond. With the success of the calculator thus far, we are working to make it applicable in the global setting to ensure all patients are able to receive fair compensation amounts. We will start by piloting in one country and determining how we can identify a comparable currency amount based on what was already programmed into the calculator. We are also assessing how to make these payments more inclusive of those who may already receive monetary support from various agencies such as Social Security Services based on recommendations from Genentech’s Patient Advocacy and Relations team. Ultimately, we plan to assess how these compensation amounts have impacted patient retention and recruitment once we have gathered enough expansive data through repeated use of the tool.