Frustrated by the cost and slow death pace of drug development, a group of researchers today launched a new unique strategy for clinical trials execution. Their goals are bold. They want to bring many products being tested in a single framework, validation of new biomarkers, data from the public, maintain uniform standards across a wide range of drug candidates, and quickly eliminate the losers. Predicted to cost $ 26 million over 5 years, the project will begin testing new therapies for breast cancer. The leaders say they hope that clinicians working on other diseases copy their experience and melanoma may be next. The experience is launched just about 60% funded, according to its developer, the independent Foundation for the National Institutes of Health.
The project is called I-SPY 2, which just means "the series of studies Survey to predict therapeutic response with your molecular imaging and analysis 2." (It follows a trial driver called I-SPY 1.) the first patients will be enrolled next week, said Laura Esserman, a surgeon at the University of California, San Francisco, who briefed reporters at the National Press Club in Washington, DC She is clinical head the trial. She said five therapeutic agents were selected for initial testing.
Anna Barker, deputy director of the National cancer Institute, said a systemic reform of the trial system is " long overdue. "
One of the promised benefits of the project is a coherent set of knowledge, said Janet Woodcock, director of the Center for evaluation and research on drugs at the US Food and Drug Administration. She called an "experience with a high probability of success." Senator Arlen Specter of Pennsylvania (D) appeared at the briefing to give I-SPY 2 his blessing and remind people that he pushed to increase the annual budget of the national Institutes of health from $ 30 billion to $ 40 billion.
the main objective of I-SPY 2, according to Esserman and others, is to reduce the time it takes for a green or red light for a new drug against the potential breast cancer 10 years to 1 year. other objectives are to identify drugs that work best for cancer patients, using new biomarkers to describe more precisely than before the game between the subtypes and disease treatments. the new strategy provides for the administration of drugs before surgery, usually doctors make the first imaging and surgery precisely the response of tumors before to move to a prolonged medication.
The approach also requires a new set of statistical methods to enable to obtain credible results small test groups. The plan is to predict early drugs that are likely to succeed and which are not, and quickly promote the winners to greater (phase III) trials, which would most likely be run by private companies, without sharing data. Biostatistician Don Berry MDAnderson Cancer Center in Houston, Texas, oversees the data analysis I-SPY 2. The concept, he said, is to continually add new drugs to several weapons in the process, promote few, and remove the rest. Berry concluded: "We hope this trial will last forever"
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