Currently, new medical devices or pharmaceuticals or put through extensive, costly, and often large “comparative” trials in which one group of patients is treated with an old method; the purpose is to both assess safety and efficacy of the new method/drug as compared to the old.
This procedure is already inappropriate for many “orphan” diseases, or situations in which no comparator exists.
In the future, as specific diseases are matched to the patient’s genome- and we find, for example, that cancers are really different in differing patients – establishing such large groups as we have done in the past may no longer be possible. In effect, each patient may become his/her own control.
Please read the entire thread in SCIENCE if you are interested in differing opinions on this topic.
Click here for Dr. Marcus’ letter.