Today s Presentation ABOUT US. Herna Joy Gonzalez, RN, BSN, MS, CCRP

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1 Herna Joy Gonzalez, RN, BSN, MS, CCRP Torrance Memorial Medical Center April 11, 2018 Today s Presentation Discuss the need for elderly representation in research Highlight the underrepresentation of the elderly in clinical trials Identify barriers and strategies to the recruitment and adequate representation of the elderly in clinical research ABOUT US 446-Bed Large Community Hospital Magnet Designated since 2011 NICHE Designated since 2017 Approx RNs Clinical Research Department 2 RNs NICHE DESIGNATED HOSPITAL 1

2 Clinical Research Medical research involving human subjects Observational Interventional Registry Diagnostic Assay Device Drug 26 Cancer Trials 12 Non-Cancer Trials Clinical Research Nursing A specialty nursing practice focused on Care of the Research Participant Fidelity to the Research Protocol Incorporates human subject protection care coordination and continuity contribution to clinical science and clinical practice study management 2

3 Why do we need adequate representation of the elderly in clinical research? TODAY million Americans are age 65 years and older projected to more than double to 98 million > 65 < 65 > 65 < 65 Rise in chronic conditions that mostly affect the elderly Heart Disease Cancer Alzheimer's disease 3

4 Metabolism THE FACTS Leading cause of death among the elderly, US and globally million Americans > 60 years of age have heart disease. Advancing age is the greatest risk factor. 66 is the median age at diagnosis. Physiologic Changes that Occur with Aging gastric ph splanchnic blood flow gastric motility Absorption hepatic blood flow overall liver mass Distribution body fat mass total body water lean body mass Excretion declining kidney function Other Factors that Affect the Elderly s Response to Drugs Polypharmacy Osteoporosis Arthritis Arrhythmias Comorbidities Diabetes Hypertension COPD Frailty CAD 4

5 A Look at Clinical Trials for Heart Disease Bourgeois et al (2017) reviewed 839 randomized clinical trials investigating drug therapies for ischemic heart disease. > % > % Cherubini et al (2011) reviewed 251 clinical trials investigating therapies for heart failure (HF). > 80 7% (HF Prevalence: >60%) Many studies explicitly excluded the elderly based on arbitrary age limit. Indirect exclusion from comorbidity, physical disability and polypharmacy. A Look at Clinical Trials for Cancer Scher & Hurria (2012) reviewed multiple clinical trials that led to the approval of 24 drugs for cancer treatment from 2007 to 2010: > 65 33% > 75 10% In a more recent study presented at the AACR in 2017, enrollment data from all completed cancer therapeutic trials from 2003 to 2016: > 65 36% Randomized Controlled Clinical Trial Population Treatment Follow-up Random Compare Results Control Follow-up 5

6 Recommendations from the : The trial population should be representative of the target patient population Include > 100 elderly patients in phase 2 and 3 database Collect post-marketing data if low geriatric population in the study Include any limitations in the product labeling In addition to measuring outcomes of survival and disease progression, include effects on cognitive function, physical functional capacity, and independence. FDA s Drug Trial Snapshots 6

7 Low health literacy / Language Barrier Perception of research/ Mistrust Financial and logistic issues e.g. driving to site Lack of home care support to help with study compliance. Family members, caregivers, or primary MDs refusal. Clinicians perceptions of the elderly and aging. Lack of knowledge, for many physicians, about the availability of suitable clinical trials for their individual patients. Trial ineligibility because of stringent inclusion and exclusion criteria. Fewer clinical trials aimed at older patients. 7

8 Improve communication. Have frequent contacts. e.g. Periodic phone calls. Send holiday cards. Provide and simplify audiovisual materials e.g. develop tools with pictures and larger fonts Minimize subject burden. Provide flexible appointments. e.g. Conduct home visits or coordinate visits with other doctor visits. Arrange transportation. Maximize the benefit:burden ratio e.g. extra attention, presence of an advocate Get the family and primary healthcare involved. Establish a good working relationship with physician groups. 8

9 Create studies specific to the elderly population. Eliminate upper age limits entirely. Increase funding and government subsidies for studies aimed at older populations. In two clinical trials on heart failure that we have recently done: Investigational Device > 75 of age 100% > 80 of age 75% Biomarker Assay > 65 of age 70% > 75 of age 30% Thank You 9

10 References: Benjamin, E. J., Blaha, M. J., Chiuve, S.E., Cushman, M., Das, S.R., Deo, R.,... Muntner, P. (2017). Heart disease and stroke statistics update: a report from the American Heart Association. Circulation, 135(10), e146-e603. Bourgeois, F. T., Orenstein, L., Ballakur, S., Mandl, K. D. and Ioannidis, J. P. A. (2017), Exclusion of Elderly People from Randomized Clinical Trials of Drugs for Ischemic Heart Disease. J Am Geriatr Soc, 65: Cherubini, A., Oristrell, J., Pla, X., Ruggiero, C., Ferretti, R., Diestre, G.,... Mills, G. H. (2011). The persistent exclusion of older patients from ongoing clinical trials regarding heart failure. Archives of Internal Medicine, 171(6), Denson, A. C., & Mahipal, A. (2014). Participation of the elderly population in clinical trials: barriers and solutions. Cancer Control, 21(3), Food and Drug Administration. (2012). Guidance for industry: E7 Studies in support of special populations: geriatrics: questions and answers. Herrera, A. P., Snipes, S. A., King, D. W., Torres-Vigil, I., Goldberg, D. S., & Weinberg, A. D. (2010). Disparate inclusion of older adults in clinical trials: priorities and opportunities for policy and practice change. American Journal of Public Health, 100(Suppl 1), S105-S112. Howlader N, Noone AM, Krapcho M, Miller D, Bishop K, Kosary CL, Cronin KA (eds). SEER Cancer Statistics Review, , National Cancer Institute. Bethesda, MD. Mather, M., Jacobsen, L. A., & Pollard, K. M. (2015). Aging in the United States. Population Bulletin, 70(2). McMurdo, M. E., Roberts, H., Parker, S., Wyatt, N., May, H., Goodman, C.,... Dyer, C. (2011). Improving recruitment of older people to research through good practice. Age and Ageing, 40(6), Scher, K. S., & Hurria, A. (2012). Under-representation of older adults in cancer registration trials: known problem, little progress. Journal of Clinical Oncology, 30(17),