Improving Representation of Diverse Patients in Clinical Trials

Transcription

1 Improving Representation of Diverse Patients in Clinical Trials Coleman Obasaju, MD, PhD, Senior Medical Director US Medical Division, Oncology, Eli Lilly and Company

2 Lilly s commitment to clinical diversity Our mission: Lilly makes medicines that help people live longer, healthier, more active lives. Tailored therapeutics focus area Historical approach: drug development is one-size-fits-all. Goal: improve individual patient outcomes and health outcome predictability through tailoring the drug, dose, timing of treatment and relevant information Eli Lilly and Company 2

3 Cancer: Matching population to prevalence 2006: 8 trials and 250 patients 2007: 6 trials and 238 patients 2008: 7 trials and 103 patients 2009: 29 trials and 1,563 patients 2010: 23 trials and 1,649 patients Cancer Prevalence - Estimated prevalence percent a on January 1, 2006, of the SEER 11 population diagnosed in the previous 16 years By Age at Prevalence, Race/Ethnicity and Sex (SEER is Surveillance Epidemiology and End Results part of the National Cancer Institute)

4 Lung Cancer: Matching population to prevalence 2006: 4 trials and 70 patients 2007: 4 trials and 194 patients 2008: 3 trials and 44 patients 2009: 6 trials and 639 patients 2010: 6 trials and 769 patients Lung Cancer Incidence SEER Stat Fact Sheet, Reference: Horner MJ, Ries LAG, Krapcho M, Neyman N, Aminou R, Howlader N, Altekruse SF, Feuer EJ, Huang L, Mariotto A, Miller BA, Lewis DR, Eisner MP, Stinchcomb DG, Edwards BK (eds). SEER Cancer Statistics Review, , National Cancer Institute. Bethesda, MD; based on November 2008 SEER data submission, posted to the SEER web site, 200

5 Lilly s clinical diversity strategy Objective: Look earlier and often for medically-relevant differences in drug response. Consistently consider a broader range of data sources, assess heterogeneity of response, and use data indicating non-response to inform future research strategies. Objective: Increase enrollment of diverse patients in Phase 3 and 4. Minority participation in US components of phase 3 and 4 clinical trials will better reflect US disease prevalence. 2 new diverse sites per eligible trial Proactively translate all patient materials into Spanish Some areas at Lilly, like oncology, have progressed more of global strategy Objective: Collect, analyze, and disclose more specific demographic information Collect race sub-category data for all Phase 3 and 4 clinical trials Eli Lilly and Company 5

6 Lilly s diversity in clinical trials strategy Location of 229 new diverse clinical trial sites 20 centers in the Central Northeast 7 centers in New England 6 centers in the Central Northwest 57 centers in the Pacific 14 centers in the Mountain West 18 centers in the Mid Atlantic 24 centers the Central Southwest Clinical Trial Therapeutic Area Oncology 57 centers in the South Atlantic Endocrine Neuroscience Osteoporosis Urology 3 centers in Hawaii and Alaska 2011 Eli Lilly and Company 8 centers in the Central Southeast 15 centers in Puerto Rico 6

7 Complex problems require partnerships Increasing awareness of need for diverse patients and investigators, in partnership with: NMA, NHMA, ENACCT Latino Advisory Board Result: Latino Toolkit developed in partnership with ENACCT available later this year after pilot in Oncology (Culturally competent tools for ICD, etc.) 2011 Eli Lilly and Company 7

8 Oncology study Prospective observational study to assess impact of race and ethnic origins on outcomes and resource utilization during 2 nd - line treatment of NSCLC. We observed barriers to enrollment of minority patients, including: lack of awareness of clinical research, lack of opportunity, lack of acceptance, language barriers Differences in baseline characteristics observed Solutions from this trial have been applied to our broader strategy Outcomes data to be discussed this fall 2011 Eli Lilly and Company 8

9 Oncology advisory boards US EU Sept 3-4, 2009 in Indianapolis with Oncology Diversity Leaders Objectives Understand enrollment impact on outcome disparities Discuss effective strategies and tactics Identify Lilly actions to increase minority enrollment Key deliverable: Investigator training in partnership with ENACCT Sept 9-11, 2011 in Puerto Rico with Minority Investigators Understand unique issues faced by minority investigators Gain insights into the Lilly diversity strategy and initiatives 10 African American and 9 Hispanic investigators October 2010 in Milan, Italy with Oncology organizations and investigators Goals: understand EU diversity/disparity issues in Oncology and gain insight into Lilly EU strategy Key deliverables: Initiatives to drive enrollment in partnership with key EU organizations 2011 Eli Lilly and Company 9

10 Process improvement project Reducing Disparities in Access to Oncology Clinical Trials (US sites) Assess impact of protocol design or Informed Consent Documents on diverse enrollment. Based on investigator site survey >600 investigators/coordinators contacted; 241 responses (37 percent response rate) Survey indicated that most significant barriers are: Financial concerns: insurance status Financial concerns: patient inconvenience costs Transportation: availability Transportation: distance to site Patient and family concerns about trial (risk) 2011 Eli Lilly and Company 10

11 Process improvement next steps Protocol template language Protocol templates now require language on ethnic differences, considerations and enrollment goals Site education Site awareness of potential barriers and solutions for diverse, elderly, and other underserved patients Site assessment to ensure sites have personnel that speak relevant local language Patient Navigation project Develop training for patient navigators on clinical trials to address financial and logistical barriers 2011 Eli Lilly and Company 11

12 2011 Eli Lilly and Company 12