AMCP, ISPOR and NPC have joined forces to establish the Comparative Effectiveness Research Collaborative Initiative (CER-CI) for advancing appropriate use of outcomes research including comparative effectiveness research (CER) to improve patient health outcomes.
Since there are a limited number of accepted principles for the interpretation of non-experimental design outcomes research studies for drug formulary and health care decisions, a consensus-based set of principles, combined with educational training and tools, would promote the development, application, and interpretation of appropriate evidence for health care technology and enhance the formulary decision-making process. Non-experimental design studies include observational prospective studies (such as registry studies) retrospective studies (such as claims data and medical record studies), as well as other study design and methods such as modeling or network meta-analysis. As membership-based organizations representing the leadership in managed care pharmacy, the research community and the pharmaceutical industry, AMCP, ISPOR and NPC are uniquely positioned to collaborate in advancing understanding, interpretation and appropriate use of observational studies results (including comparative effectiveness research [CER]) in a wide variability of payer coverage and formulary decisions.
The goal of the CER Collaborative Initiative is to provide greater uniformity and transparency in the use and evaluation of outcomes research information including observational studies for coverage and health care decision making by providing a user-friendly toolkit to help decision makers navigate through the various types of observational study methods used to generate outcomes research information for evidence-based health care decision making.
To achieve the goal described above the CER Collaborative Initiative is divided into three parts.
Part 1: Interpreting Outcomes Research Studies for Health Care Decision Makers
The goal of Part 1 is to develop a compendium of papers on"Interpreting Outcomes Research Studies for Health Care Decisions" for four outcomes research study types: a) prospective observational studies, b) retrospective observational database studies, c) modeling studies and d) indirect treatment comparison studies.
Part 2: Critical Appraisal of Outcomes Research across Study Methods
The goal of Part 2 is to identify a framework to assess evidence across multiple outcomes research study methods (body of evidence) including experimental design studies [randomized clinical trial studies - RCTs] and observational studies. Part 2 will address the strength of evidence for a given study relative to all available studies used to assess the evidence, and the overall strength of the evidence and certainty.
Part 3: 'Assessing the Evidence: A Toolkit for Decision Makers'
The first goal of Part 3 is the end product and the main goal of the entire initiative which is, to develop an electronic user friendly toolkit for assessing the body of evidence by decision-makers. 'Assessing the Evidence by Decision Makers: A Toolkit'
The second goal of Part 3 is to develop educational modules for health care coverage decision makers on how to use the 'Assessing the Evidence Toolkit for Decision Makers'.