Some Reflections on Clinical Trials

1. Some Reflections on Clinical Trials • Virginia R. Hetrick, Ph.D. • President • You Are Not Alone • A High-Dose Chemotherapy Support Group • Post Office Box 641103 • Los Angeles, California 90064-1103 • email: drjuice@gte.net • bellnet: 310.493.4510

2. Objectives • Identify patients' reasons for not participating in clinical trials • Determine how to publicize clinical trials information • Develop mechanism for patient education through joint efforts of physicians and patient advocates

3. Background • 1994 - Last major review of clinical trials process for oncology • Why have only 3% to 4% of newly diagnosed breast cancer patients participated in clinical trials during the past year? - B. Fisher, 1991 • Why have only about 3% of newly diagnosed breast cancer patients participated in clinical trials in the past year? - L. Rosen, 1999

4. Background (continued) • No changes in levels of participation nearly 10 years • Low participation levels perceived to be due to: • Reimbursement issues • Physician unawareness of appropriate clinical trials • Patient disinterest in participation

5. Patient participation issues -Schain, 1994 • Patient/doctor interaction issues on both sides • Patient self-protectiveness • Time and travel constraints • Quality of care in research protocol vs. standard clinical care • Nature/detail of informed consent • Quality of life in clinical trial

6. Physician participation issues - Mansour, 1994 • Lack of awareness of appropriate trials • Physican bias (trial treatment not as effective as standard treatment) • Losing patients to followup • Complexity of clinical trials affects amount of time required per patient • Lack of compensation • Excessive costs not compensated

7. What has changed? • Reimbursement issues - Fleming, 1994 • Direct cost reimbursement reduced even below 1994 levels • Even more discounting since 1994 due to increased proportion of HMO patients • Reduced insurance company coverage of ancillary costs of clinical trials since 1994

8. What has changed? (continued) • Patient attitudes • More consumer education about diagnosis and treatment • Media increases patient awareness of specific medical conditions, new medications, new treatment protocols • More active patient participation in treatment decisionmaking process

9. What has changed? (continued) • Physician logistics and attitudes • Development of larger academically-based community oncology networks • Increased physician response to patient demands • More industry and government effort to educate physicians about clinical trials

10. What has changed? (continued) • The Internet

11. Why don't patients participate? • My doctor never mentioned it to me. • Significant number of physicians do not mention clinical trials to every patient • I don't want to be a guinea pig. • Clinical trials versus the current "gold standard" not explained • Seriousness of disease not explained

12. Why don't patients participate? (continued) • I want the best treatment I can get for my disease. • Patient self-protectiveness still an issue • The media say the clinical trials for my disease are not effective. • Media spin interprets information incorrectly

13. Why don't patients participate?(continued) • I don't understand what "clinical trial" means • I don't understand what this means for my situation

14. What can we do together? • Physicians can work with patient advocates • to understand public's and their patients' concerns • to educate public about appropriateness and usefulness of clinical trials • to educate individual patients about current clinical trials for particular conditions

15. In-person patient advocate activities • Enrolling patients in the Theratope trial • Patient advocates helped spread word about trial • Organizing public presentations • Mailing information sheets • Spreading word electronically

16. In-person activities (continued) • Peer counseling • Patient advocates can: • Explain the trials process generally • Help patients understand issues related to specific treatment • Relate their experiences with trials • Training is EXTREMELY important!

17. Online patient advocate activities • Patient Advocates In Research (PAIR) • Patient advocates for many conditions • News and views • Exchange of information about specific conditions • NOT a replacement for physician-provided information

18. Disease-specific email lists • Provide exchange of specific, usually credible, information about particular conditions • Breast cancer examples • Inflammatory breast cancer list (IBC) • Breast cancer general list (breast-cancer) • Metastatic breast cancer (CLUBMets and bc-mets)

19. Effect of patient advocates • Maximize physicians' time with patients on direct treatment issues • Increase effectiveness of physicians, nurses, and psycho-social workers by • Providing triage to appropriate services/resources • Identifying educational resources for patients

20. Effect of patient advocates (continued) • Provide information research assistance to physicians about possibly appropriate trials for his/her practice • Helping keep patients "on-track" towards finding appropriate treatment

21. References • Fisher. "On Clinical Trial Participation", JCO, 9:11,1927-1930 • Fleming. "Barriers to Clinical Trials: Part I: Reimbursement Problems", Cancer 74:9 (supp), 2662-2665. • Mansour. "Barriers to Clinical Trials: Part III: Knowledge and Attitudes of Potential Participants", Cancer 74:9 (supp), 2672-2675. • Rosen. Personal communication. 19 Sep 2000 • Shain. "Barriers to Clinical Trials: Part II: Knowledge and Attitudes of Potential Participants", Cancer 74:9 (supp), 2666-2671.