Pushing past the placebo: Legislating for a new kind of clinical trials

From amednews.com:

In January, a study published in the Journal of the American Medical Association on the first two commercially available drug-eluting stents found no significant differences in clinical outcomes.

In August, a report in the New England Journal of Medicine concluded that patients with stable angina who underwent percutaneous coronary intervention showed slightly more improvement over those treated with medication. But that added benefit disappeared by 36 months.

Then in September, a study in the NEJM found that arthroscopic surgery for osteoarthritis of the knee provided no additional benefit over physical and drug therapy.

What these very different studies have in common is that they compare the effectiveness of one treatment option with another instead of on its own. Although more of this type of research is being conducted than ever before, physicians, insurers and consumer groups widely agree that not enough comparative-effectiveness data exist on pharmaceuticals, medical devices and procedures.

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Access to Clinical Trials Under Fire

From News4Jax.com

Many are stuck in clinical trials and could take more than a decade to get approved. Critics claim the FDA takes too long to give the go-ahead to life-saving medications and therapies. Others believe it's better to be safe than sorry. Lives hang in the balance of this debate.

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What do you think should be the process of getting access for individuals to particpate in clinical trials or for the approval rates for new medications from the FDA?

We'd love to hear your thoughts.

Feasibility of Multi-Phase Trials

Mahesh Paramar, Ph.D., from the Medical Research Council Clinical Trials Unit in London, along with some colleagues have "modified standard clinical trial methodology so that multiple therapies or combinations can be compared in a single trial." What this means, is that Phase II and Phase III goals are combined into a single "multi-phase trial," that also would have the benefit of needing less patients. As stated in this article, from Science Daily, Parmar and his colleagues wrote an article for the Journal of the National Cancer Institute detailing their proposal. regarding the practicality of using the approach outlined by Paramer, the authors of the proposal wrote:

"With three real examples, we hope that we have shown that such trials are feasible and can lead to major improvements in speed and decision making"