New Calculator Could Help Trial Participants And Sponsors Determine Costs And Fair Compensation

By Larry Ajuwon, director at Rhieos-Ventures and lead partner at TrialValue

Clinical trials come with benefits, risks, and costs that influence a patient’s decision to participate and affect their conduct during and after the trial. Financial, in addition to logistical, burdens have been shown to affect recruitment, access to study sites, and completion rate¹. For example, in a survey of 213 patients enrolled in early‐phase clinical trials, the monthly out‐of‐pocket costs were at least $1,000 for nearly half of patients and may reveal a cause of disparities in clinical trial enrollment for underrepresented populations².

When it comes to payments for expenses incurred and compensation for time spent by participants, there is a wide variety of practices. Based on my analysis, experience and published articles, participants globally are probably compensated between 5-20% of the estimated total cost of participation (i.e., financial impact). That means many patients will either forgo participation or decide to drop out due to the financial burden.

Barbara E. Bierer, MD, professor of medicine, Harvard Medical School, and faculty director of the Multi-Regional Clinical Trials Center of Brigham, and colleagues as well as industry expert Kamila Novak, independent consultant at KAN Consulting, have addressed this topic particularly on the fairness³ and inequality⁴ in payment practices. These authors call for more dialogue between the clinical trial community and regulators to create a more transparent and just approach to payments to study participants to enhance diversity in clinical research.

However, given that there is no industry standard or tool for estimating the financial burden to ensure patients are appropriately reimbursed and compensated, TrialValue embarked on a “moonshot mission” to ensure that no patient is burdened (or “solving for zero financial burden”)⁵ by participating in a clinical trial. As such, we have developed the industry’s first open access financial burden calculator to help patients, sponsors, and other stakeholders estimate the cost burden patients may face under applicable scenarios.

Results from four different usability tests and simulations performed by industry experts and patient advocates indicate that the calculator could be a useful resource and benchmark tool for participants, sites, sponsors, and other interested parties, such as IRBs, to determine fair and ethical compensation arrangements.

Design And Method

To identify existing tools, approaches, and frameworks, we conducted a scoping literature and internet search. We found two relevant works on this subject,^6,7,8 which were helpful in formulating a methodology for assigning participation burden based on a participant’s situation and trial logistics. We then identified three categories of input parameters and sourced data, such as protocol information, expense and stipend amounts, and average and median hourly wages, from public databases.

The calculator user interface was designed for ease of use and quick data capture without the need to type in data. The results are automatically displayed once all the forms are completed, which takes a maximum of about 15 minutes.

Modules

1. Study Burden. This section collects key details on the therapeutic area, protocol, procedures, and logistics.
2. Costs and Payment. This section collects information on the compensation method, as well as the amounts for expenses, the stipend, and the applicable minimum and mean hourly wage.
3. Results. This section displays the total financial impact, defined as the total cost of participation and completion of the study (which includes reimbursable expenses, stipend, and compensation for lost income). It is based on the selected compensation method.
   The burden impact, defined as the overall level of burden the participant is likely to experience considering their condition and the logistical, financial, physical, and mental demands related to the trial. It is based on TrialValue weighted formulae score.

How To Use The Financial Burden Calculator

First, launch TrialValue Financial Burden calculator.

Using the example scenario described below, fill out the forms and verify the results.

A patient with an autoimmune condition is considering participating in a trial to test a new drug. She lives in the U.S., works full time, and has two children (3 and 5 years old). After an initial discussion with her doctor, she wants to know the logistical demands and financial implications of the study.

Input Data:

• Protocol Information
  • Condition Burden = Medium
  • Study Type = Interventional
  • Clinic visit frequency during treatment = Monthly
  • Clinic visit frequency during follow-up = Monthly
  • Study duration = 2 years
  • Number of study visits = 24
• Procedures
  • Invasive procedure = Once
  • Hospitalization = None
  • Questionnaire and Diary usage = Medium
  • Average time spent in clinic per visit = 4 hours
  • Long-term follow-up visits = Check-up
• Participant Information
  • Age = 18-65
  • Caregiver or childcare support required = Yes
  • Clinic visit travel distance, round trip = 10-30 KM
  • Average travel time per clinic visit, round trip = 4 hours
• Compensation method
  • Participation stipend, lost income, and reimbursement
• Expense amounts
  • Travel and accommodation = $50
  • Patient support expenses = $80
• Stipend amount
  • Per visit = $50
• Mean Hourly Earning
  • Americas = $50

Conclusion: On completing the calculator with some assistance from study support staff, the patient learns the total estimated cost of participation would be $13,920 and the burden impact would be considered “high.” This information was then shared with the study team to ensure that adequate budget provision is in place.

Industry Feedback Positive So Far

I have been encouraged by the feedback, comments, and suggestions received since we launched the Clinical Trial Burden Calculator in November 2023. The general view is that it is quick to use and allows users to try different scenarios. People who reviewed the calculator, including those in clinical operations, business operations, consulting, and patient advocacy roles, like the ability to put a dollar figure on the burden easily as well as assign the logistic burden. But, our work has not yet finished.

Several people said the usability and user interface can be improved and the language should be patient-friendly. As for the technical side, we will update certain parameters so it can be applied to studies with a shorter duration. On the results, we plan to add more explanation on how to interpret the data and include guidance on employing the calculator to aid patient engagement conversations.

Feedback and stories of real-life use are encouraged, so we can continue to increase adoption and foster dialogue with all participants (i.e., patients, patient advocates, IRBs, sponsors, regulators, etc.) involved in the clinical research enterprise.

About The Author:

Larry Ajuwon, MSc., is the director at Rhieos-Ventures and lead partner at TrialValue, an independent clinical research financial benchmarking platform. Ajuwon has been involved in clinical research and development for over 24 years. Ajuwon works with biopharmaceutical companies, contract research and patient organizations, service providers, and academic institutions to broaden access to healthcare solutions.

Contributors (reviewers and usability testers):

Kamila Novak tested the first version of the financial burden calculator, reviewed the drafts, and provided valuable editorial comments and advice that made the writing of this article possible.

Adeline HUPÉ, TrialPEX, reviewed the beta version of the financial burden calculator and provided valuable feedback on usability, content, structure, and parameters.

Clarinde Cerejo, a patient advocate, reviewed the final draft version of the calculator and provided in-depth and valuable feedback on usability, language, and design.

Kimberly Richardson, a patient advocate, reviewed the launched calculator and provided valuable suggestions on usability.

I am very grateful to the development team and many colleagues, friends, and partners who have supported this work.

References:

1. Williams CP, Geiger AM, Norton WE, de Moor JS, Everson NS. Influence of Cost-Related Considerations on Clinical Trial Participation: Results from the 2020 Health Information National Trends Survey (HINTS). J Gen Intern Med. 2023 Apr;38(5):1200-1206. doi: 10.1007/s11606-022-07801-0. Epub 2022 Nov 30. PMID: 36451016; PMCID: PMC9713084. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9713084/
2. Huey RW, George GC, Phillips P, White R, Fu S, Janku F, Karp DD, Naing A, Piha-Paul S, Subbiah V, Tsimberidou AM, Pant S, Yap TA, Rodon J, Meric-Bernstam F, Shih YT, Hong DS. Patient-Reported Out-of-Pocket Costs and Financial Toxicity During Early-Phase Oncology Clinical Trials. Oncologist. 2021 Jul;26(7):588-596. doi: 10.1002/onco.13767. Epub 2021 Apr 21. PMID: 33783054; PMCID: PMC8265355. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8265355/
3. Bierer BE, White SA, Gelinas L, Strauss DH. Fair payment and just benefits to enhance diversity in clinical research. J Clin Transl Sci. 2021 Jul 14 https://pubmed.ncbi.nlm.nih.gov/34527298/
4. Should We Pay Patients In Clinical Trials For Their Time? Kamila Novak, Clinical Leader article, September 29, 2022. https://www.clinicalleader.com/doc/should-we-pay-patients-in-clinical trials-for-their-time-0001
5. Of Sunshine and Patient Access: Solving for “Zero Financial Burden” in our Clinical Research-to-Care Enterprise, Larry Ajuwon, blog post. https://www.rhieosventures.com/blog/2023/1/25/of-sunshine-and-patient-access-solving-for-zero-financial-burden-in-our-clinical-research-to-care-enterprise
6. Towards a fair and transparent research participant compensation and reimbursement framework in Vietnam. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7651161/
7. Quantifying Participant Burden In Clinical Trials: Data From Prostate Cancer RCTs. https://www.researchsquare.com/article/rs-1339592/v1
8. Reimbursement and Allowances for Trial Participants Regulation (EU) No 536/2014 Approved Model by National Coordination Centre of Ethics Committees, Nov. 10th, 2022 - version n°3. https://www.aifa.gov.it/documents/20142/1783350/Modello_Indennita_part_spese_sper_CCN_EN.pdf