1. Clinical trials in the Elderly What are we missing? Jan C. Buckner, MD Chicago, IL May, 2015

2. Outline Eligibility screening data Trial data Data collection methods

3. Eligibility Screening What are we missing? Why do older patients not enroll in clinical trials? Frailty Can the Geriatric Assessment guide us? Comorbidities Which exclusion criteria eliminate eligibility? Patient preference What are the goals of medical care?

4. Trial Data What do we collect? Eligibility parameters Basic demographics (age/gender/ethnicity) Laboratory parameters Treatment administered Toxicity (CTCAE) Patient experience (PRO) Imaging changes (Response/Progression) Vital status

5. Trial Data What are we missing? Expanded demographic data Education Geographic location Income Behavioral parameters Tobacco use Alcohol use Diet Exercise

6. Trial Data What are we missing? Psychosocial Depression Fatigue Social support Global QOL

7. A191401 ALLIANCE patient questionnaire A pilot study to determine questionnaire feasibility (Paul Reiter, PhD, Jeff Sloan, PhD) Opened 3/16/2015 Participating sites: Academic: OSU, Mayo, RPCI, WFUSM, UNC Community: Doctor’s Hospital of Laredo, UNM, Delaware/Christiana Care CCOP, Upstate Carolina CCOP, Michigan Cancer Research Consortium

8. Objectives - Reiter Assess if feasible to integrate the ALLIANCE Patient Questionnaire into Alliance protocols and have patients complete the questionnaire. Determine patient satisfaction with the ALLIANCE Patient Questionnaire. Establish initial norms for various key components of the ALLIANCE Patient Questionnaire for use in the design of future studies.

9. Study Details - Reiter The patient population includes all patients who enroll in the identified Alliance clinical trials (i.e., parent trials) (N=200) Stand-alone study. If necessary, the questionnaire can be done with the aid of an interpreter, family member or medical professional.

10. Domains on Survey - Reiter Demographic constructs: - age, gender, race/ethnicity, languages spoken at home, education level, military service, marital status, sexual orientation, health insurance coverage, number of people in the household, income, and home address Health and health behaviors: - Tobacco and alcohol use, physical activity, diet, existing health conditions, and self-rated health Psychosocial variables: - self-reported quality of life, anxiety, fatigue, distress, depression, loneliness, pain and social support Four items that assess patient satisfaction with the questionnaire

11. Data collection methodology What are we missing? Tumor registry electronic transfer EHR direct transfer Direct patient entry

12. A191401 ALLIANCE patient questionnaire The survey will be self-administered, with patients completing the survey via iPad If necessary, the questionnaire can be done with the aid of an interpreter, family member or medical professional All resulting questionnaire data will be stored in real time in Medidata RAVE clinical trials database

13. Summary Missing data preclude our understanding of: Generalizability of outcomes Impact of confounding variables upon outcomes Technology exists to: Capture potential confounding variables Improve data collection efficiency