be focused on solving compelling problems, and, if the solutions developed are not important, if they do not make a large difference, then maybe the effort to continue is not justified.

Another participant expressed concern about the discussion of evidence-based medicine (EBM) because most of what is done in medicine today is not completely evidence-based, and it most certainly is not supported at the level of RCTs. Physicians incorporate a great deal of retrospective data when making their judgments. Is it reasonable to say that in the future everything must be prospective, randomized trial data? Presumably the answer is no.

When discussing EBM, one must be careful not to equate EBM with prospective, multi-center RCTs as the only way that physicians should make decisions. Not everything will be tested. Whether a drug works better in a 20-year-old versus a 21-year-old is not something worth testing. Judgment must be used.

It is not reasonable for insurers to require multi-center randomized controlled prospective trials if they are not paying for them, the speaker continued. Who will pay for these trials? If a high level of evidence is required, someone must pay to obtain that evidence. Physicians use evidence to improve their practice, but if it is incorrectly used or unreasonably required, evidence can be a bar to innovation.

Berg agreed but said that in the absence of evidence, no one is suggesting that nothing should happen. Clinicians and patients are accustomed to dealing with uncertainty; that is what much of the practice of medicine is about. Nonetheless, it is extremely important that someone draw a scientific line in the sand and say what it is we know and what we do not know, confronting and looking at the evidence objectively in order to determine whether it is worth the investment to fix.

There may be many questions that are not worth investing in, but there are many questions where we are currently saying, “Well, is it okay to substitute our judgment?” when in reality an investment should be made. The investment is long overdue, because there are many, many important clinical questions that could be answered but that are not being answered. Finding the answers is a public good that all should support, Berg said.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement