We have recently seen a lot of activity regarding the Patient-Centered Outcomes Research Institute (PCORI), an independent, non-profit health research organization. PCORI will have an estimated $3 billion over the next decade to fund CER. The Patient Protection and Affordable Care Act (PPACA) established PCORI in Section 6301 and Section 10602, Public Law 111-148.
PCORI was created to conduct research to provide information about the best available evidence to help patients and their health care providers make more informed decisions. PCORI’s research is intended to give patients a better understanding of the prevention, treatment and care options available, and the science that supports those options. Its mission is to fund research that offers patients and caregivers the information they need to make important healthcare decisions.
As we noted a few weeks ago, PCORI recently came out with issued its draft list of National Priorities for Research and Research Agenda. PCORI will provide a 53-day public comment period on its first National Priorities for Research and Research Agenda. The comment period concludes at 11:59 p.m. ET on Thursday, March 15, 2012.
Consequently, the Drug Information Association (DIA) and the National Pharmaceutical Council will be offering a two-day educational conference about Comparative Effectiveness. The conference is taking place on March 14-15, 2012 at the Renaissance Washington DC Hotel, in Washington, DC.
The meeting will highlight the changing nature of evidence standards within the marketplace; specifically, the continued push for increased levels of evidence of comparative effectiveness applied within health technology assessments (HTAs). The goal of the meeting is to focus less on definitions and theoretic concepts, and more on the application of comparative effectiveness research (CER) and HTA within drug development and research planning.
While the discussion of CER has been ongoing for years, the recent creation of the PCORI within health care reform, as well as new standards for evidence evaluation development by leading payers, have made understanding not just the theories, but rather their applications, of vital importance.
This meeting will push beyond the basic questions to evaluate the importance of CER and provide participants with actionable understandings of how CER evidence can be better managed and developed within their own organizations.
Unlike previous efforts in this area, this meeting will provide participants with a “what does it mean for me” perspective on CER and HTA, providing take-aways to apply within day-to-day drug development and marketing positions.
Learning Objectives
At the conclusion of this meeting, participants should be able to:
- Define comparative effectiveness research techniques within their day-today activities
- Describe how to use internal evidence-generation and application strategies with the specific market sectors they support (e.g., payor markets, providers, etc.)
- Translate evidence of product effectiveness for best application within multiple market settings
Sessions
The program, which boasts and esteemed planning committee and list of faculty, will have a number of exciting and interesting sessions over the course of two days.
CER Research Design: From Principle to Practice
The advent of comparative effectiveness research (CER) raises a multitude of questions: what specific types of studies to fund, how to prioritize resources, how to involve stakeholders, and how to organize and oversee organizations that will sponsor and carry out the research. The complexities involved underscore the need for tenets or principles that can help govern and provide a framework to the entire CER enterprise. This session will be set up in three parts:
- Part I: Comparative Effectiveness Policy Background, Perspectives, and Issues
- Part II: Application of CER Principles by CER Researchers
- Part III: Reaction Panel: Views and opinions of developers and end users of CER data
Heterogeneity of Treatment Effects in Comparative Effectiveness
This session will address the heterogeneity of treatment effects in comparative effectiveness research. The fact that patients with the same diagnoses respond differently to the same treatment has long been established. New information on the three major categories of causes, genetic/biologic, illness severity (or baseline risk), and extra-disease factors such as co-morbidity, socio-economic status, and non-adherence proneness, will be discussed. Inter-study heterogeneity and non-average patient responses will also be discussed.
- Part I: Heterogeneity in Effectiveness Research
- Part II: Application of Heterogeneity Concepts in Current CE Studies
- Part III: Reaction Panel: How companies view aspects of heterogeneity
Often what’s lost in comparative effectiveness discussions is how to balance the competing needs of various sectors of the health care industry. How patient-focused should research be, if doing so it limits the ability to extrapolate findings to larger population settings? Should costs be considered simultaneously with clinical effectiveness, or when comparative clinical effectiveness is not available?
Balancing Clinical, Health, and Cost Outcomes in Comparative Effectiveness Research
This session will examine both the opportunities and challenges associated with trying to balance these, at times, competing demands within research. Attendees will also hear from leaders representing three key perspectives on this topic — patient-focused research, payer decision makers, and manufacturers, who will highlight both similarities and departures in how interrelated sectors approach these questions.
- Part I: (Cost) Effectiveness: Challenges and Opportunities in Research
- Part II: Addressing These Needs: Three Perspectives on Research Demands from the Field
- Part III: Reactor Panel
Be Bold, Be Brave, Be Knowledgeable: A Practical Guide to Making the Case for CER in Your Company
The best CER methods and applications are for not if researchers, and those that manage research, cannot successful make the case for their implementation within their own companies. This session will help those in attendance understand how to align and defend CER study designs with market needs in a way that will make communicating those research needs more effectively within their own management structures. Building on that foundation, panelists will offer insights into how that internal communication can occur, as well as share experiences from across industry with regard to how these efforts have occurred in the past.
- Part I: Aligning Study Designs and Business Needs: A Practical Guide
- Part II: Making the Case for CER: “Once More Unto the Breach…”
- Part III: Reaction Panel: Insight from industry
For more information about the conference or to register, click here.