Models to Identify and Support Clinical Trial Participants
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1 Models to Identify and Support Clinical Trial Participants Income Disparities in Cancer Clinical Trial Enrollment: Evidence and Models for Patient Support Joseph Unger, Ph.D. SWOG Statistical Center Fred Hutchinson Cancer Research Center Seattle, WA
2 Income Disparities in Clinical Trials: BACKGROUND Conceptual Model: Study to Diffusion of New Cancer Therapy Drug Development Laboratory discovery of anti - cancer agent Comparative Testing (Phase III) Design Interpretation Public (CMS) or Private (Health Insurance Co.) Treatment Coverage Decisions Animal testing Monitoring Analysis Generalizability Diffusion Early human testing (MTD Phase I; anti - cancer activity, Phase II) Representativeness Physician and Patient - Level Treatment Decisions Academic/Research Setting (T1) Community Setting (T2)
3 Income Disparities in Clinical Trials: BACKGROUND Representativeness Representativeness: How the characteristics of clinical trial cohort compare to treatment population Only 2-3% of adult cancer patients participate in NCI-sponsored clinical trials* * Murthy, JAMA, 2004; Tejeda, JNCI, 2006
4 Income Disparities in Clinical Trials: BACKGROUND Conceptual & Study Design Model for Assessing Factors Influencing Clinical Trial Participation Clinic Visit Trial Available No Trial Available Patient Eligible Not Eligible Offered trial Did not offer trial Participated Did Not Participate Potential differential non-participation related to SES/demo factors Javid et al, The Oncologist, 2012 PRESENTED BY: Joseph Unger, M.S., Ph.C. Unger et al, JCO, 2013
5 Income Disparities in Clinical Trials: BACKGROUND SES and Clinical Trial Participation Clinical trial participation by SES not well studied Absence of patient-level SES data in NCI-sponsored trials Despite evidence suggesting that SES may be related to both access and outcomes for a range of diseases Whitehall studies (Marmot, Lancet, 1991) Link & Phelan, Social Conditions as Fundamental Causes of Disease, 1995
6 Income Disparities in Clinical Trials: BACKGROUND SES and Clinical Trial Participation (cont d) One approach: Use area-level SES estimates from zip code (matched to Census data) as partial surrogate for patient-specific SES Useful for statistical adjustment but represents different construct Factors pertaining to neighborhood or regional environment Inadequate for examining relationship between SES and trial participation
7 Income Disparities in Clinical Trials: EVIDENCE Web Survey Study Design Need to reach beyond the usual consortiumsponsored cooperative group data Web-based survey study Collaboration with NexCura, provider of online treatment decision tools for cancer patients Linked to major cancer oriented websites (i.e. American Cancer Society)
8 Income Disparities in Clinical Trials: EVIDENCE Study Design (cont d) Adult patients with new diagnosis of breast, lung, colorectal, or prostate cancer Conducted over 4 year period ( ) Collected patient level income and education Also age, sex, race, distance to clinic, comorbidity status
9 Income Disparities in Clinical Trials: EVIDENCE Online Survey Study with NexCura Geographic Distribution Distribution of NexCura of Survey Survey Respondents Region % in Survey Sample West 25% 23% Midwest 21% 22% Northeast 19% 18% South 35% 37% % in U.S. 5,499 patients surveyed (overall rate = 9.0%) 9
10 Income Disparities in Clinical Trials: EVIDENCE Regression Results for Income Income only SES or demographic factor significantly associated with clinical trial participation in multivariable regression Income <$50,000/year, 27% less likely to participate (p=.01) Cutpoint % Less Likely P-value $20,000 44%.02 $35,000 27%.04 $50,000 27%.01 $100,000 21%.04
11 Income Disparities in Clinical Trials: EVIDENCE Forest Plot Association of Income and Clinical Trial Participation by Each Study Factor: Association is Independent of Subgroup Membership Factor Category Sample Size p- OR value Age >65 years <65 years Sex Female Male Race African American White Education <College >College Comorbidities 0 or > Distance To Clinic <13 miles >13 miles OVERALL Odds of Clinical Trial Participation for Lower Income Patients: Lower Odds Higher Odds
12 Income Disparities in Clinical Trials: EVIDENCE Concern about How to Pay Assessed patient attitudes toward CTs Lower income patients much more concerned about how to pay for CT treatment (p<.0001) 53% for <$20k/year vs. 24% for >$100k/year Concerned About How To Pay 50% 40% 30% 20% <$20k $20k-$34.9k $35k-$49.9k $50k-$99.9k >$100k Yearly Income Patients Not Offered a CT
13 Income Disparities in Clinical Trials: DISCUSSION Main Findings In multivariate model, lower-income patients much less likely to participate in a clinical trial Lower-income patients much more concerned about how to pay for CT participation
14 Income Disparities in Clinical Trials: DISCUSSION Potential Reasons for Income Finding Is there an insurance effect? Consistent finding in subset of patients >65 years covered by Medicare Is there an impact of state laws mandating coverage of clinical trials? No evidence that association of income and clinical trial participation differed by type of state (i.e. with vs. without insurance mandate)
15 Income Disparities in Clinical Trials: DISCUSSION Clinical Trial Costs Are CTs more expensive? NCI: Patient care costs for clinical trials are not appreciably higher than for non-trial care Costs of Cancer Treatment Study (RAND)* Non-significant 6.5% increase for trial patients No increase is prescription out-of-pocket costs** But patient cost concerns much higher among lower-income patients * Goldman, JAMA, 2003 ** Kilgore, Contemp Clin Trials, 2008
16 Income Disparities in Clinical Trials: DISCUSSION Clinical Trial Costs (cont d) Concerns about how to pay for treatment in general may interact with anxiety about trial participation to produce a differential impact on lower income patients Lower income patients may be more sensitive to: - Direct costs (co-pays and co-insurance) - Indirect costs (time off work for extra clinic visits) Policy Implications: Find ways to help lower-income patients with direct and indirect costs of clinical trial participation
17 Income Disparities in Clinical Trials: POLICY PRESCRIPTIONS Cover Co-Pays/Co-Insurance Cover excess costs for clinical trials for all patients Even in an insured population, co-pays and coinsurance deters clinical trial participation* Percent 50% 40% 30% 20% 2000: Year of Medicare Policy Change % > 65 yrs % Med + Private P-value % > 65 yrs 26.5% 38.1% <.0001 % Med+Private 8.3% 15.2% <.0001 % Med Only 9.9% 9.7%.50 10% % Med Only 0% Year of Enrollment * Unger, JCO, 2006
18 Income Disparities in Clinical Trials: POLICY PRESCRIPTIONS Payments to Participants Pay individuals to participate in NCI-sponsored clinical trials In 1900, military surgeon Walter Reed paid subjects $100 in gold to participate in his yellow fever experiments* In U.S., the practice of paying patients for trial participation is widespread, but also contentious, highly variable, and lacking in general guidance** * Lederer, 1995 ** Grady, 2005
19 Income Disparities in Clinical Trials: POLICY PRESCRIPTIONS Payments to Participants (cont d) Careful calibration of size of monetary incentive to avoid undue influence per US Common Rule for Protection of Human Subjects Concern is that a payment inducement might alter a subject s assessment of potential risks or impair their judgment. Little evidence that payment inducements do or do not do this See Grady, Payment of clinical research subjects (J Clin Invest, 2005)
20 Income Disparities in Clinical Trials: POLICY PRESCRIPTIONS Policy Prescriptions (cont d) Some worry that payments to patients would produce a disproportionate burden of research on lower income patients In contrast, offering no money also has the potential to skew the subject pool and contravene distributive justice * Series of tradeoffs and an ethical debate: What are tradeoffs between benefit to society, benefit to individual, and potential harms to individuals * Grady, 2005
21 Income Disparities in Clinical Trials: POLICY PRESCRIPTIONS Payment Models* Market Model: Market determines how much to pay in order to recruit the number and type of subjects needed in a given time frame Based on traditional libertarian theory (supply and demand) Higher payments when: Low intrinsic incentive for participation Need to accrue quickly Small eligible patient pool Lower payments when high intrinsic incentive for participation * Dickert & Grady, NEJM, 1999
22 Income Disparities in Clinical Trials: POLICY PRESCRIPTIONS Payment Models (cont d) Wage-payment model: Payment offered to compensate for time, contribution to study, and effort/discomfort Based on egalitarian perspective that participants performing similar functions should be paid similarly Amounts to payment based on a standardized hourly wage (i.e. unskilled labor rate) Completion bonuses to encourage compliance Dickert & Grady, NEJM, 1999
23 Income Disparities in Clinical Trials: POLICY PRESCRIPTIONS Payment Models (cont d) Reimbursement model: Payment offered to reimburse participants for actual expenses Based on egalitarian perspective and the idea that research participation should be revenue neutral for participants (i.e. no financial sacrifice or gain) One approach: Reimbursement for travel, meals, parking, etc. Alternative: Reimbursement as well for time away from work Dickert & Grady, NEJM, 1999
24 Income Disparities in Clinical Trials: POLICY PRESCRIPTIONS Payment Model of Choice* Wage-payment model Greatly reduces the common worry about undue influence Standardization among studies will: Contain the cost of research More egalitarian: Does not favor only well funded studies Easier to determine payment Avoids risk-adjusted payments, so encourages risk minimization Adheres to principle of justice : Treats people serving similar functions similarly *Dickert & Grady, NEJM, 1999
25 Income Disparities in Clinical Trials: POLICY PRESCRIPTIONS Direct to Consumer Advertising Direct-to-consumer-advertising (DTCA) targeted in particular to lower income patients DTCA has increased in recent years* Awareness of oncology-related DTCA is high among cancer patients** * Donohue, NEJM, 2007 ** Abel, JCO, 2009
26 Income Disparities in Clinical Trials Conclusion Why is income representativeness important?
27 Income Disparities in Clinical Trials Conceptual Model: Study to Diffusion of New Cancer Therapy Drug Development Laboratory discovery of anti - cancer agent Comparative Testing (Phase III) Design Interpretation Public (CMS) or Private (Health Insurance Co.) Treatment Coverage Decisions Animal testing Monitoring Analysis Generalizability Diffusion Early human testing (MTD Phase I; anti - cancer activity, Phase II) Representativeness Physician and Patient - Level Treatment Decisions Academic/Research Setting (T1) Community Setting (T2)
28 Income Disparities in Clinical Trials Conclusion Why is income representativeness important? Feasibility Better participation of lower income patients could speed the conduct of clinical trials Interpretation Better participation of lower income patients would better assure the applicability of clinical trial results to all income levels Fairness Clinical trials offer the newest treatments, so crucial that all income groups have equal access to trials
29 Thank You
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