Are clinical trials really all that effective?

By ACSH Staff — Jul 15, 2013
Clinton Leaf, author of The Truth in Small Doses: Why We re Losing the War on Cancer


Clinton Leaf, author of The Truth in Small Doses: Why We re Losing the War on Cancer and How to Win It, wrote an article which appeared in the New York Times this past Sunday entitled Do Clinical Trials Work, analyzing just how much progress these trials are getting us in the fight against cancer. The answer he arrives at: Not so much.

He takes the example of Avastin, most recently looked at as to its effectiveness in treating patients with brain cancer. He says, Indeed, even after some 400 completed clinical trials in various cancers, it s not clear why Avastin works (or doesn t work) in any single patient ¦That we could be this uncertain about any medicine with $6 billion in annual global sales and after 16 years of human trials involving tens of thousands of patients is remarkable in itself. And yet this is the norm, not the exception. Do clinical trials even work? Or are the diseases of individuals so particular that testing experimental medicines in broad groups is doomed to create more frustration than knowledge?

And he goes on to question whether results from clinical trials can even be generalizable to the populations that would benefit most from these cancer treatments. Roughly 53 percent of new cancer diagnoses, for example, are in people 65 or older, but this age group accounts for just 33 percent of participants in cancer drug trials. Even if clinical researchers could match the demographics of study populations to those of the likely users of these medicines, no group of trial volunteers could ever match the extraordinary biological diversity of the drugs eventual consumers.

His answer? Rather than try to fit patients, a handful at a time, into the decades-old clinical-trials framework, we d be far better off changing the trials themselves.

Perhaps to make progress in treatment of cancer, it s time for a change. ACSH s Dr. Gilbert Ross agrees: Since studies have shown that within cancerous growths, the variation in genetic fingerprints is astounding, I think the real breakthrough in cancer treatment will come when cancer researchers can develop drugs which attack specific genotypes rather than tissue-based origins.

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