The Elephant in the Room
This is a disturbing editorial from Nature about the state of oncology clinical trials. Do not misunderstand that first sentence: there is a very well-organized and active system of clinical trials, and many people participate each year. Thanks to their willingness to be part of a trial, we have learned a great deal about cancer care. Frankly, we all stand on their shoulders, as nothing would have been explored rigorously or learned without them.
However, the truth seems to be that late stage clinical trials have the highest failure rate — meaning the tested drugs turn out to be of no value — of any speciality group. I frequently talk with women who are participating or considering participating in a trial. Sometimes, it makes a lot of sense to do so. I myself was part of a trial for my first breast caner in 1993. That trial was about timing of chemotherapy and radiation, rather than the usual sequence of first one and then the other; this trial had patients do both simultaneously. The good news was that it got the whole thing over with a bit sooner. The bad news, as you guessed, is that it was really tough going for the six weeks of combined treatments. My point, however, is that choosing that trial still meant that I would receive the standard care (radiation and chemo), and I hoped/expected that the outcome out be good.
Very often, people consider trials at a very different phase in their cancer care. Instead of a slight shift, per above, in the beginning, they have exhausted many standard treatments, are dealing with advanced disease, and are hoping for a little magic. There are always questions about informed consent — that is, how informed actually is it? Do people understand the very small possibility of benefit from the medication? Let me be clear: I completely understand and fully support the need for clinical trials and the importance of patients having choices and opportunities. Without them, medicine would not advance, and some hope would be lost.
This is, however, a very sobering essay. Here is the beginning and a link:
Oncology trials-the elephant in the room
Rebecca Kirk & Lisa Hutchinson
Each year, when new annual cancer incidence and mortality statistics are published, the media are quick and happy to report that cancer mortality is reducing, despite some increases in incidence. There is a lot for the oncology community to celebrate and be proud of in these declining mortality rates and the decades of work that have produced them. However, late-phase clinical trials for anticancer drugs have the highest failure rates of all the clinical areas. Furthermore, those drugs that are successful often do not provide sufficient improvement on already available therapies, meaning that healthcare providers often cannot afford to make them available to the patients they were designed for. Against this backdrop, it is time to discuss oncology clinical trials — the elephant in the room.
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