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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Continued Growth in India's Clinical Trials

We've been frequently updating you on the rise in Clinical Trials in India, another news story on this growth has come up today that we wanted you to be aware of.

From Press Trust of India:

Clinical trials in India to test the safety and efficacy of newly invented drugs or medical devices have shown a huge growth and registered nearly a five-fold increase in the last four years, a top official said today."In 2005, around 100 clinical trials had been approved in the country by the Drugs Controller of India (DCI). In 2006, it increased to around 150 and to 240 in 2007. In the current year, around 450 have already been approved," Joint Drugs Controller of India, A B Ramteke, told reporters on the sidelines of a conference here today.

What do you make of this rise in Indian Clinical Trials? We'd love to hear your thoughts.

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.

How to evolve your trials

At Pharma Exec, they recently looked at how companies can evolve their trials so that they can become more efficient. They need to start by looking at and solving the current problems to evolve their efficiency. Before a trial starts, the companies need to predict more of what will happen in the trial, such as: more clinical trials, adaptive trials, regulations, geographies in which to conduct trials, and outsourcing partners. However, the key to successfully evolving clinical trials lies within the clinical trials supply chain. Find out more here.