Comparative Effectiveness Research (CER) to the tune of 1.1 billion dollars is part of the economic stimulus package – see here. Whereas much of the money will be used to compare medical treatments, (drugs and procedures) medical devices are also included in CER. What this means is not clear but one could speculate that questions may be asked such as
· Is pharmacogenomic testing for Coumadin therapy effective?
· Is percent free PSA useful?
· Is Point of Care troponin as effective as a lab troponin?
Implied in these questions are:
What is the dollar cost of the procedure? What information does it provide over other procedures (increase in sensitivity and specificity). How much does this information add – either to a more accurate medical decision or quality of life?
If all of this begins to happen, then the biggest requirement is to ensure that unbiased data analysis methods are used. This means that:
· Clear, quantitative goals are required
· Study designs are chosen that are practical and will address the questions
· Standards for data collection and analysis are used
· Results are written such that recommendations and conclusions are supported by the data
Statisticians can play a key role in providing clarity and quality – they need to be included as full members of this effort (part of the design team) and not relegated to “crunching the numbers.”