Research safety and efficiency? Does that seem like an odd combination? Might someone even say impossible? Well I don't know about that, but I do know some of the mechanisms in place to keep research safe and to protect the rights of participants can seemingly bog down the research experience, not to mention increase the cost. The Wall Street Journal Health blog reports on an effort by Duke University and the FDA to improve the nation's clinical trial process http://blogs.wsj.com/health/2007/11/20/duke-fda-put-clinical-trials-on-the-examining-table/.
No matter the changes to the clinical trial process, patient safety must remain paramount. Every regulation has a face behind it. The regulations are in place because there has been terrible abuse among research participants. But efficiency is also a worthwhile goal. And an efficient clinical trials process may mean that drugs get approved sooner, at less cost, but are still properly examined for safety and efficacy.
Reforming the clinical trials process will be an arduous task. But it is a process that will only succeed if the parties involved keep their eye on the goal of safe and efficient clinical trials and not exclusively on the fiscal bottom line.
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