The phase 1–3 schema described above can broadly be fitted to any new technique or drug combination; however, requirements differ in different countries. Trials comparing existing drugs in novel combinations are often undertaken by academic organizations such as Cancer Research UK or the US National Cancer Institute.  Using the template above will give reliable results that can influence practice and are the gold standard for advancing medical practice in general. The system becomes much less clear with surgical techniques, radiotherapy equipment, other devices, and biomarkers, though. For example, new technologies such as robotic surgery are introduced as incremental improvements. These ‘improvements’ are treated as self-evident, when, in fact, they may be nothing of the sort. For example, comparing open with robot-assisted surgery: access routes to the body are different; the tactile connection between the surgeon’s hands and the tissues is lost in robot-assisted surgery; control of bleeding or complications such as bowel perforation may present different risks, possibly requiring conversion from robot-assisted to an open conventional operation; theatre times may be longer when surgeons are training, and so on. It is clearly entirely plausible that each of these factors may substantially affect outcomes. In addition, there is the massive issue of cost. A surgical robot costs over £1 million, with another £100,000–£150,000 annual running costs.  Even if the outcomes are better, how much is it worth paying for, say, and earlier discharge from hospital?

One might expect that the introduction of such a technique, for example for prostate removal, would require the same sort of trials that new drugs for prostate cancer require, with equivalence or better in outcomes.  No such trial has ever been carried out, yet surgical robots are working in major surgical centres across the world, particularly in the USA. Why the massive discrepancy? In essence, new devices simply have to demonstrate safety and fitness for the purpose for which they are designed.  Where changes are genuinely small and incremental clearly a massive trial to show that a new scalpel is slightly better would be impractical and probably meaningless.  At some point, the change ceases to be incremental and surgical robots seem to me to be a good example of this, yet are still treated as if they were simply a slightly better scalpel. In the USA in particular, buying a surgical robot has become an essential part of the marketing of a hospital – it is an iconic piece of kit – what go-ahead institution would want to be without one? Grappling with this issue is likely to become more and more important as healthcare systems struggle with rising costs. Conceivably, of course, new technologies may actually save costs. Sticking with the robots, it is not implausible that the claimed shorter learning curve, shorter hospital stay, and reduced complication rates could pay back the capital and running costs. At present, however, we simply don’t know.

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