An Analysis of Incentive Schemes for Participant Retention in Clinical Studies

References

• Acland D, Levy MR (2015) Naiveté, projection bias, and habit formation in gym attendance. Management Sci. 61(1):146–160.Link, Google Scholar
• ActivMed (2021) Join a trial in Methuen, MA. ActivMed Practices & Research, LLC. Accessed January 11, 2023, https://activmedresearch.com/join-a-trial/methuen-ma/#!/study/571.Google Scholar
• Adida E, Bravo F (2019) Contracts for healthcare referral services: Coordination via outcome-based penalty contracts. Management Sci. 65(3):1322–1341.Link, Google Scholar
• American Automobile Association (2019) Your driving costs. Heathrow, FL. Accessed January 11, 2023, https://exchange.aaa.com/wp-content/uploads/2019/09/AAA-Your-Driving-Costs-2019.pdf.Google Scholar
• Arora V (2019) Inpatient sleep loss: Educating and empowering patients (ISLEEP). Accessed January 11, 2023, https://www.clinicaltrials.gov/ct2/show/NCT04151251.Google Scholar
• Atlant Clinical (2020) Patient retention in clinical trials: Problems, costs and solutions. Accessed January 11, 2023, https://www.atlantclinical.com/patient-retention-in-clinical-trials.Google Scholar
• Bellos I, Kavadias S (2021) Service design for a holistic customer experience: A process framework. Management Sci. 67(3):1718–1736.Link, Google Scholar
• Bentley JP, Thacker PG (2004) The influence of risk and monetary payment on the research participation decision making process. J. Med. Ethics 30(3):293–298.Crossref, Google Scholar
• Bertsimas D, Sturt B (2020) Computation of exact bootstrap confidence intervals: Complexity and deterministic algorithms. Oper. Res. 68(3):949–964.Link, Google Scholar
• Bertsimas D, Korolko N, Weinstein AM (2019) Covariate-adaptive optimization in online clinical trials. Oper. Res. 67(4):1150–1161.Abstract, Google Scholar
• Booker CL, Harding S, Benzeval M (2011) A systematic review of the effect of retention methods in population-based cohort studies. BMC Public Health 11(1):249.Crossref, Google Scholar
• Borno HT, Zhang L, Siegel A, Chang E, Ryan CJ (2018) At what cost to clinical trial enrollment? A retrospective study of patient travel burden in cancer clinical trials. Oncologist 23(10):1242.Crossref, Google Scholar
• Burd N (2020) Anti-inflammatory milk matrix (AIMM). Identifier NCT04216004. Accessed January 11, 2023, https://clinicaltrials.gov/ct2/show/NCT04216004.Google Scholar
• Calzolari G, Nardotto M (2017) Effective reminders. Management Sci. 63(9):2915–2932.Link, Google Scholar
• Carrera M, Royer H, Stehr M, Sydnor J (2020) The structure of health incentives: Evidence from a field experiment. Management Sci. 66(5):1890–1908.Link, Google Scholar
• Charness G, Gneezy U (2009) Incentives to exercise. Econometrica 77(3):909–931.Crossref, Google Scholar
• Chin R, Lee BY (2008) Principles and Practice of Clinical Trial Medicine (Elsevier, Academic Press, Cambridge, MA).Google Scholar
• ClinicalTrials.gov (2020) Learn about clinical studies. Accessed January 11, 2023, https://clinicaltrials.gov/ct2/about-studies/learn.Google Scholar
• Colvin M, Maravelias CT (2010) Modeling methods and a branch and cut algorithm for pharmaceutical clinical trial planning using stochastic programming. Eur. J. Oper. Res. 203(1):205–215.Crossref, Google Scholar
• Corbett CJ, DeCroix GA (2001) Shared-savings contracts for indirect materials in supply chains: Channel profits and environmental impacts. Management Sci. 47(7):881–893.Link, Google Scholar
• CORDIS (2019) Estimating a monetary value of health: Why and how? Accessed January 11, 2023, https://cordis.europa.eu/article/id/411538-estimating-a-monetary-value-of-health-why-and-how.Google Scholar
• Dumville JC, Torgerson DJ, Hewitt CE (2006) Reporting attrition in randomised controlled trials. BMJ 332(7547):969–971.Crossref, Google Scholar
• Fabbri M, Coelho M, Abreu D, Correia Guedes L, Rosa MM, Costa N, Antonini A, Ferreira JJ (2016) Do patients with late-stage Parkinson’s disease still respond to levodopa? Parkinsonism Related Disorders 26:10–16.Crossref, Google Scholar
• Fleischhacker A, Ninh A, Zhao Y (2015) Positioning inventory in clinical trial supply chains. Production Oper. Management. 24(6):991–1011.Crossref, Google Scholar
• Fleischhacker AJ, Zhao Y (2011) Planning for demand failure: A dynamic lot size model for clinical trial supply chains. Eur. J. Oper. Res. 211(3):496–506.Crossref, Google Scholar
• Fogel DB (2018) Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp. Clinical Trials Commun. 11:156–164.Crossref, Google Scholar
• Fountoulakis KN, Veroniki AA, Siamouli M, Möller H-J (2013) No role for initial severity on the efficacy of antidepressants: Results of a multi-meta-analysis. Ann. General Psychiatry 12(1):1–10.Crossref, Google Scholar
• Furukawa TA, et al. (2015) Initial severity of schizophrenia and efficacy of antipsychotics: Participant-level meta-analysis of 6 placebo-controlled studies. JAMA Psychiatry 72(1):14–21.Crossref, Google Scholar
• Giuffrida A, Gravelle H (1998) Paying patients to comply: An economic analysis. Health Econom. 7(7):569–579.Crossref, Google Scholar
• Goh J, Bayati M, Zenios SA, Singh S, Moore D (2018) Data uncertainty in Markov chains: Application to cost-effectiveness analyses of medical innovations. Oper. Res. 66(3):697–715.Link, Google Scholar
• Grady C, et al. (2005) Payment of clinical research subjects. J. Clinical Investigation 115(7):1681–1687.Crossref, Google Scholar
• Grand View Research (2022) Clinical trials market size, share & trends analysis report by phase (Phase I, Phase II, Phase III, Phase IV), by study design, by indication (Pain Management, Oncology, CNS Condition, Diabetes, Obesity), by Region, and segment forecasts, 2022–2030. Accessed January 11, 2023, https://www.grandviewresearch.com/industry-analysis/global-clinical-trialsmarket.Google Scholar
• Grant RW, Sugarman J (2004) Ethics in human subjects research: Do incentives matter? J. Medicine Philos. 29(6):717–738.Google Scholar
• Gresham GK, Ehrhardt S, Meinert JL, Appel LJ, Meinert CL (2018) Characteristics and trends of clinical trials funded by the National Institutes of Health between 2005 and 2015. Clinical Trials 15(1):65–74.Crossref, Google Scholar
• Hauser JR, Simester DI, Wernerfelt B (1994) Customer satisfaction incentives. Marketing Sci. 13(4):327–350.Link, Google Scholar
• HHS.gov (2019) Attachment A—Addressing ethical concerns offers of payment to research participants. Accessed January 11, 2023, https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-a-september-30-2019/index.html.Google Scholar
• Holmstrom B, Milgrom P (1987) Aggregation and linearity in the provision of intertemporal incentives. Econometrica 55(2):303–328.Crossref, Google Scholar
• Hu C, Zhou H, Sharma A (2020) Applying beta distribution in analyzing bounded outcome score data. AAPS J. 22(3):1–9.Crossref, Google Scholar
• Hu Y, Shin J, Tang Z (2016) Incentive problems in performance-based online advertising pricing: Cost per click vs. cost per action. Management Sci. 62(7):2022–2038.Link, Google Scholar
• Huang L, Frijters P, Dalziel K, Clarke P (2018) Life satisfaction, QALYs, and the monetary value of health. Soc. Sci. Medicine 211:131–136.Crossref, Google Scholar
• Hui D, Glitza I, Chisholm G, Yennu S, Bruera E (2013) Attrition rates, reasons, and predictive factors in supportive care and palliative oncology clinical trials. Cancer 119(5):1098–1105.Crossref, Google Scholar
• Institute of Medicine (IOM) (2010) Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary (The National Academies Press, Washington, DC).Google Scholar
• Kling A (2006) Crisis of Abundance: Rethinking How We Pay for Healthcare (Cato Institute, Washington, DC).Google Scholar
• Kouvelis P, Milner J, Tian Z (2017) Clinical trials for new drug development: Optimal investment and application. Manufacturing Service Oper. Management 19(3):437–452.Link, Google Scholar
• LaBeaud AD, et al. (2011) Postepidemic analysis of Rift Valley fever virus transmission in northeastern Kenya: A village cohort study. PLoS Neglected Tropical Diseases 5(8):e1265.Crossref, Google Scholar
• Lafontaine F, Slade ME (1996) Retail contracting and costly monitoring: Theory and evidence. Eur. Econom. Rev. 40(3–5):923–932.Crossref, Google Scholar
• Li C (2013) Sourcing for supplier effort and competition: Design of the supply base and pricing mechanism. Management Sci. 59(6):1389–1406.Link, Google Scholar
• Lopienski K (2015) Retention in clinical trials—keeping patients on protocols. Report, Forte Research Systems, Madison, WI.Google Scholar
• Ma Q (2021) Bictegravir in the elderly living with HIV (BICEP). Identifier NCT05064020. Accessed January 11, 2023, https://clinicaltrials.gov/ct2/show/NCT05064020.Google Scholar
• Miller TR, Hendrie DV (2012) Economic Evaluation of Public Health Laws and Their Enforcement, PHLR Methods Monograph Series (Robert Wood Johnson Foundation, Princeton, NJ).Google Scholar
• Moore TJ, Zhang H, Anderson G, Alexander GC (2018) Estimated costs of pivotal trials for novel therapeutic agents approved by the US Food and Drug Administration, 2015-2016. JAMA Internal Medicine 178(11):1451–1457.Crossref, Google Scholar
• National Research Council (2010) The Prevention and Treatment of Missing Data in Clinical Trials (National Academies Press, Washington, DC).Google Scholar
• NJAES (2019) The financial impact of improved health behaviors. Accessed January 11, 2023, https://njaes.rutgers.edu/health-finance/health-behaviors.php.Google Scholar
• Nuttall A (2012) Considerations for improving patient recruitment into clinical trials. Clinical Leader Newsletter (March 23), https://vertassets.blob.core.windows.net/download/64c39d7e/64c39d7e-c643-457b-aec2-9ff7b65b3ad2/rdprecruitmentwhitepaper.pdf.Google Scholar
• Palar K (2021) Pilot trial of the nutrition-supported diabetes education program (NU-DSMP). Identifier NCT05067452. Accessed January 11, 2023, https://clinicaltrials.gov/ct2/show/NCT05067452.Google Scholar
• Parkinson B, et al. (2019) Designing and using incentives to support recruitment and retention in clinical trials: A scoping review and a checklist for design. Trials 20(1):1–14.Crossref, Google Scholar
• Patel V (2019) Social media based peer-led intervention for HIV prevention. Identifier NCT03213366. Accessed January 11, 2023, https://clinicaltrials.gov/ct2/show/NCT03213366.Google Scholar
• Patlak M, Nass S, Institute of Medicine, National Cancer Policy Forum (2008) Improving the Quality of Cancer Clinical Trials: Workshop Summary (National Academies Press, Washington, DC).Crossref, Google Scholar
• Persad G, Lynch HF, Largent E (2019) Differential payment to research participants in the same study: An ethical analysis. J. Medical Ethics 45(5):318–322.Crossref, Google Scholar
• Resnik DB (2015) Bioethical issues in providing financial incentives to research participants. Medicolegal Bioethics. 5:35.Crossref, Google Scholar
• Retinal Consultants of Houston (2019) Treat & extend treatment with 0.5mg ranibizumab vs monthly treatment with 0.5mg ranibizumab (T-REX). Accessed January 11, 2023, https://clinicaltrials.gov/ct2/show/NCT01748292.Google Scholar
• Ripley EB (2006) A review of paying research participants: It’s time to move beyond the ethical debate. J. Empirical Res. Human Res. Ethics 1(4):9–19.Crossref, Google Scholar
• Roels G (2014) Optimal design of coproductive services: Interaction and work allocation. Manufacturing Service Oper. Managment 16(4):578–594.Link, Google Scholar
• Shon M, Shin J, Hwang J, Lee D (2021) Free contents vs. inconvenience costs: Two faces of online video advertising. Telematics Informatics 56:101476.Crossref, Google Scholar
• Soffin E (2020) Enhanced recovery after spine surgery. Identifier NCT02949518. Accessed January 11, 2023, https://clinicaltrials.gov/ct2/show/NCT02949518.Google Scholar
• Stresman GH, et al. (2018) Do hotspots fuel malaria transmission: A village-scale spatio-temporal analysis of a 2-year cohort study in the Gambia. BMC Medicine 16(1):160.Crossref, Google Scholar
• Swanson G (2020) Circadian misalignment in inflammatory bowel disease. Identifier NCT04637399. Available at https://clinicaltrials.gov/ct2/show/NCT04637399.Google Scholar
• Tarter TH (2015) Expanded access to diagnostic imaging for staging of recurrent prostate cancer: Study protocol and statistical analysis plan. Accessed January 11, 2023, https://www.clinicaltrials.gov/ct2/show/NCT02260817.Google Scholar
• Tian Z, Han W, Powell WB (2022) Adaptive learning of drug quality and optimization of patient recruitment for clinical trials with dropouts. Manufacturing Service Oper. Management 24(1):580–599.Link, Google Scholar
• U.S. FDA (2018). Payment and reimbursement to research subjects: Guidance for institutional review boards and clinical investigators. Accessed January 11, 2023, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/payment-and-reimbursement-research-subjects.Google Scholar
• Van Lith T (2021) Mindfulness-based art therapy and Generation Z. Accessed January 11, 2023, https://clinicaltrials.gov/ct2/show/NCT04834765.Google Scholar
• Wittes J (2002) Sample size calculations for randomized controlled trials. Epidemiologic Rev. 24(1):39–53.Crossref, Google Scholar
• Wong HH, Jessup A, Sertkaya A, Birkenbach A, Berlind A, Eyraud J (2014) Examination of clinical trial costs and barriers for drug development. Accessed January 11, 2023, https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development.Google Scholar
• Yao X, et al. (2021) Batch enrollment for an artificial intelligence-guided intervention to lower neurologic events in patients with undiagnosed atrial fibrillation: Rationale and design of a digital clinical trial. Amer. Heart J. 239:73–79.Crossref, Google Scholar
• Zhao Y (2021) Triple therapy for postoperative nausea and vomiting in laparoscopic gastrointestinal surgery. Accessed January 11, 2023, https://www.clinicaltrials.gov/ct2/show/NCT04853147.Google Scholar