1. Dr. Rachel Syme AD, Institute of Cancer Research, CIHR Dr. Bernie Eigl Provincial Director, Clinical Trials, BCCA Incremental Costs of Cancer Clinical Trials

2. Background Clinical trials are currently facing a national funding crisis A widely held perception that costs of care for trial patients are higher than standard of care continues to be a barrier to research in many cancer centres. Costs are routinely recovered for “above standard- of-care” activities by sites

3. Background True costs of clinical trials are generally not well understood and estimates are highly variable Current, accurate, Canadian data pertaining to costs are limited

4. Study Question Is there a difference in the direct medical costs incurred by cancer patients on clinical trials versus eligible non- participants? Do “standard of care” patients truly represent less cost to “the system”?

5. Study Design A retrospective observational cohort study was conducted to examine how the costs incurred by cancer patients randomized into a clinical trial compared with the costs incurred by eligible non- participants who received standard care Examined two separate tumour groups

6. Study Design Matched eligible non-participants 52 week window Variables examined were physician and nursing time; tests and procedures; diagnostics and imaging; pathology; radiation therapy; and therapeutics prescribed

7. Study Design EligibleIneligible ParticipantNon-participant Cancer Clinical Trials $$

8. Analysis Controls matched by trial eligibility and date of consent/decline Simple, non-parametric two-tailed t- test Ho: u 1 = u 2 No difference Ha: u 1 ≠ u 2 Difference in resource utilization

9. Tumor Group 1: Prostate n=59

10. Total Costs

11. Tests and Procedures

12. Imaging

13. Radiotherapy Costs

15. Prostate Results Summary There was no evidence to support a difference in overall resource utilization between clinical trials and standard of care patients There was variability in the types of resources used by each patient population

16. Tumour Group 2: Breast n=97

17. Total Costs

18. Costs by type

20. Breast Results Summary Mean costs were marginally higher for CT patients than SOC patients for all seven cost variables as were mean total costs After excluding drugs that were provided by the study sponsors the mean difference between total costs was reduced by two-thirds, from $6,396 to $2,227 and statistical significance was lost (p=0.14). This does not take into account that many investigations/procedures for study patients are reimbursed

21. Conclusions These two studies revealed only minor differences in the cost distribution of patients enrolled in CT versus those receiving SOC, if any.

22. Conclusions Clinical research is sometimes viewed as a luxury by health-care administration. A thorough understanding of any added costs or demands of having a patient enrolled in a trial, or conversely, cost savings as a result of patients participating in research, would be beneficial for researchers and administrators to inform decision making and budget negotiations in a setting of limited resources

23. Overall Lessons/Conclusions Perceptions that trials are costly to a center Take extremely more time and resources It is important to understand the true impact of Clinical Trials on Sites Important component of Advocacy

24. Conclusions Together with other benefits of doing clinical trials…..

25. Other Benefits…. JOB CREATION PATIENT ACCESS TO NEW AGENTS RESEARCH SAVES LIVESRESEARCH SAVES MONEY RECRUIT THE BEST BY BEING THE BEST RESEARCH DRIVES CME RESEARCH BRINGS GRANTS RESEARCHERS TAKE BETTER CARE OF PATIENTS STATE OF THE ART FACILITIES

26. Its a no brainer….

27. Acknowledgements CUOG MBT Program UC Britney Jones Misha Eliasziw

28. Questions?

29. A quantitative study comparing the utilization of out-patient chemotherapy resources for trial and non-trial patients

30. Determine the impact of trial patients on out-patient chemotherapy department Compare treatment administered Number of visits Treatment time recorded “Do clinical trial patients occupy more treatment resources?”

31. Trial patients occupied 14.18 % of the total chemotherapy visits Average of 49 out of 347 total chemotherapy visits per week Trial patients utilize chemotherapy resources consistently Clinical Trial Patients Total Patients 14.18%

32. administering chemotherapy to trial patients did not require significantly more time 2.63 hours of for trial patients 2.57 hours for non-trial patients Non- Trial Patients Trial Patients