Randomized Prospective Trials of Innovative Radiotherapy Technology Are Necessary

The most important clinical problem facing radiation oncology is whether randomized prospective trials are necessary to assess innovative technologies. Some radiation oncologists feel strongly that randomized trials are unnecessary, because highly conformal beams are self-evidently worthy, and the only interesting question is the magnitude of the gain, not whether a gain is achievable. Supporters of randomized trials invoke a long list of historical examples wherein such trials demonstrated the uselessness of technologies that were thought to be “self-evidently” better. Physicians with financial or academic career interest in the promotion of innovative technologies are not objective parties in this debate. There are also considerable opportunity costs of investments in expensive innovative technologies. It is possible to identify innovations that should be required to meet the standard of proof of a benefit in a randomized prospective clinical trial before being introduced into widespread clinical practice.