Tag: Clinical Trials

Can Health 2.0 Fix Clinical Trials?

Saturday’s New York Times portends more trouble for big Pharma. The headline is wrapped up in an examination of foreign corrupt practices, but the bigger issue is that clinical trials have hidden serious adverse events. The recent allegations that GSK hid data about heart attacks from an Avandia trial conducted abroad highlight the reality that over the last 20 years or so it’s been very hard to recruit patients for clinical trials in the US. It’s expensive to find patients, and the numbers of patients available near centers has not proved enough. The answer has been to go to places with lots of people and lower costs, like India.

One obvious consequence is that few of the significant advantages of Internet connectivity and patient community which have been developing in recent years have been adopted as part of these pre- or post market trials. Several online communities–notably PatientsLikeMe–have been running their own studies but they have typically been observational studies and haven’t had much acceptance from Pharma or regulators.

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The Evidentiary Basis for a Clinically Meaningful Benefit

We entered the 21st century awash in “evidence” and determined to anchor the practice of medicine on the evidentiary basis for benefit. There is the sense of triumph; in one generation we had displaced the dominance of theory, conviction and hubris at the bedside. The task now is to make certain that evidence serves no agenda other than the best interests of the patient.

Evidence-based medicine is the conscientious and judicious use of current best evidence from clinical care research in the management of individual patients”. [1,2]

But, what does “judicious” mean? What does “current best” mean? If the evidence is tenuous, should it hold sway because it is currently the best we have? Or should we consider the result “negative” pending a more robust demonstration of benefit? Ambiguity is intolerable when defining evidence because of the propensity of people to decide to do something rather than nothing. [3] Can we and our patients make “informed” medical decisions on thin evidentiary ice? How thin? Does tenuous evidence mean that no one is benefited or that the occasional individual may be benefited or that many may be benefited but only a very little bit?Continue reading…

Better Care Through Clinical Trials



Amid hundreds of amendments offered in the health care reform debate, there is a non-partisan, non-controversial gem that will both help patients and speed the search for new cures to deadly diseases.

Senators Sherrod Brown [D-OH] and Kay Bailey Hutchison [R-TX] have proposed an amendment that would encourage patients with life-threatening diseases or conditions to participate in clinical trials by requiring private insurers to cover patients’ routine care. It is essential that the Senate pass this amendment as part of health care reform.

As a cancer physician, I can speak to the benefits of clinical trials in my field of oncology. Virtually every advance in cancer prevention, screening, and treatment over the last 40 years can be traced directly to clinical trials – colonoscopies; curative treatment for testicular cancer; improved survival for most pediatric cancers; chemotherapy after surgery to prevent recurrence; new personalized therapies that target specific characteristics of cancer cells; and symptom management. Thanks primarily to the knowledge gained through clinical trials, today two-thirds of cancer patients survive at least five years after diagnosis, compared with only half in the 1970s.Continue reading…


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