Until recently, medical decisions were highly subjective, being called “clinical judgment”, “the art of medicine” or “in my experience”. To gain knowledge, practitioners got their information from reading textbooks whose information is over 3 years old and a few journal articles. To keep up to date, reading the vast amount of journal articles published in each specialty is not only impractical, but also places a tremendous time commitment on clinicians. In today’s practice of medicine, evidence-based medicine (EBM) advocates that, to the greatest extent possible, clinical decisions should be based on scientific evidence derived from clinical trials published in the medical literature. There are a number of resources that use EBM to critically appraise medical devices and procedures to provide clinicians access to the latest verifiable scientific evidence. These include PubMed, The Cochrane Database of Systematic Reviews, TRIP Database, AHRQ, DARE, National Guideline Clearinghouse, and NICE.
Researchers have developed a hierarchy to assess the strength of scientific evidence and study designs. Prospective, multicenter, randomized, blinded and controlled clinical trials comparing the patient clinical outcomes against the current standard of care is on a high level and are more robust than its less rigorous counterparts, such as case series and expert opinions, which is at the bottom.
Why should you care? Because all payers make their coverage and payment decisions predicated on the principles of EBM. One of the most damaging mistakes that manufacturers make is to take it upon themselves to design a study without the input of a consultant who specializes in reimbursement strategy. One of the largest stumbling blocks is that you fail to put yourself in the shoes of a Health Plan medical director who makes the coverage decisions. You must understand the principles of EBM to design the most suitable clinical trial to accumulate top-quality scientific evidence to present to payers to ensure a positive coverage decision. Your success and profitability depend on your recognizing the crucial importance of EBM.
Hope this helps,