Comparative effectiveness research, although a relatively new term, has been a long-standing approach used to compare the effectiveness of new treatment entries compared with existing ones. The methods and outcomes of comparative effectiveness research must be regarded as objective and credible. Consequently, comparative effectiveness research must be of the highest quality:

• Clearly conceived (the design is well constructed and executed);
• Collaborative (so that payers, clinicians, patients, and industry find that the results meaningfully improve patient care); and
• Transparent (with regard to study objectives, methods, and references used; authorship disclosures; and circumstances (sensitivities) in which findings do not hold).

Furthermore, the results must be:

• Understandable (rather than obtuse or obscured by jargon or complex methods);
• Meaningful (insofar as they inform quality of care); and, above all,
• Replicable (so methods can be refined or corrected and new entrants can be fairly compared against the established benchmark).

BioMedEcon’s comparative effectiveness research expertise includes:

• In-depth comparative analyses of clinical trial methods and findings;
• Large-scale retrospective claims analyses (such as Medicaid, Medicare, NIH, FDA Manufacturer and User Facility Device Experience (MAUDE) databases);
• Systematic literature reviews and meta-analyses;
• Clinical chart reviews;  
• Quality of life research; and
• Time-and-motion studies.