This is the eleventh in a series of interviews between CFAH President and Founder Jessie Gruman and patient and consumer group leaders about their experiences with and attitudes toward comparative effectiveness research (CER).
Gruman: Tell me about yourself and your organization.
Donna Cryer: As I enter my 19th year as a liver transplant recipient, I have the privilege of having recently been named President & CEO of the American Liver Foundation, the oldest and largest patient organization working on liver diseases and conditions. At the Foundation, we are committed to bending the curve of health care to serve the needs of liver patients and their families.
Gruman: Where do you see comparative effectiveness research (CER) fitting in the effort to improve the effectiveness of health care?
Donna Cryer: Comparative effectiveness research has tremendous potential to enrich the patient-provider dialogue with data on the relative merits of treatment options available in clinical practice. Right now there is limited information to fuel those conversations. Information currently available is mostly provided by traditional placebo-controlled clinical trials whose study populations seldom reflect the clinical, ethnic or socio-economic diversity of the actual disease population.
Gruman: Tell me how your organization views the relationship between CER and patient-centered outcomes research (PCOR).
Donna Cryer: CER and PCOR should be redundant. However, as with most clinical research, CER almost never includes patients in the design, review or conduct (beyond serving as subjects). For this reason, PCOR has the potential of focusing CER on questions and concerns that matter to patients in their navigation through their journey rather than only the issues that are top of mind for physicians.
Gruman: Can you give me an example of how your constituents have been affected by CER?
Donna Cryer: Fortunately, due to continued innovation in liver-related drug development, patients have more treatment options than ever. Additionally, better understanding of disease progression and the predictive effects of genotyping can inform treatment decisions if it is integrated into the process. A good example of comparative effectiveness research that is needed for people with liver cancer is providing information that helps patients and physicians navigate their medical or surgical treatment options and the methods of communicating those options.
Gruman: How do you see the increased attention to CER affecting the care your constituents will receive in the future?
Donna Cryer: The increased attention to comparative effectiveness research ' specifically PCOR ' will hopefully positively affect a) the acceleration and uptake by hepatologists and gastroenterologists of the most effective treatment options for liver patients, b) the understanding of patients and their families of the best treatment for themselves and their satisfaction with the treatment selection process, and c) the types of interaction and participation liver patients have with research and the research community.
Gruman: Some professionals believe that patients are opposed to comparative effectiveness research. Do you think this is accurate? ' If so, what do you think is behind this view?
Donna Cryer: Patients are not opposed to comparative effectiveness research. I think they understand its value to health care decision-making. But physician-scientists and policymakers rightly perceive the inherent tension between personalized medicine and CER as commonly understood.
Many patients fear that the results of CER will be applied in a manner that denies access to treatments that are only effective in patients at the ends of the bell curve. With further precision in the design of CER, it can truly become a tool for the advancement of personalized medicine and individualized therapy by validating the greater effectiveness of certain drugs for patients with specific biomarkers or clinical characteristics.
Gruman: What are your fears and hopes for CER?
Donna Cryer: I would caution against two things as comparative effectiveness research moves forward:
First, we should be wary of the insincere use of the term patient-centered and the failure to fully enjoin patients as co-designers of the research agenda and studies. This includes the failure to provide training for patients in biomedical study terms, terminology, and statistics to be able to participate meaningfully.
And second, we should be concerned about the insistence of generalizing comparative effectiveness research to the point where innovation is stalled and effective treatments are denied for sub-populations of patients.
More CER Interviews by Jessie Gruman