A clinical approach to technology assessment: how do we and how should we choose the right treatment?

The evidence required to support the use of new technology in medicine differs from that required for new drugs. On one extreme, very little may be required for small devices, but on the other strong evidence is required to support the use of truly novel, potentially dangerous, and high-cost machines. The randomized controlled trial is built into the evaluation of drugs and suits them well. It is not so well suited to the evaluation of major devices in which installation costs and return on investment are important. We discuss where the randomized controlled trial may still play a role and what alternatives may exist when this is not possible. We also discuss the role that independent bodies may have in determining whether or not a new device is not only safe but also adds to the medical landscape in a way that justifies its cost.