14.09.2018 kl 21:39 3608

Tror noen bør lese denne artikkelen om igjen. Det er lurt å lytte til sjefen i FDA.

“As part of our ongoing efforts to advance more efficient ways to develop medical products, the FDA is encouraging pioneering new ways that innovators can modernize the way they conduct clinical trials,” said FDA Commissioner Scott Gottlieb, M.D. “The approach we’re describing in new guidance today is to help innovators to evaluate drugs in trials that are potentially lower cost, more efficient, and could enable us to learn more about the safety and efficacy when compared to traditional trial designs. We’ve outlined how drug developers can use an innovative seamless trial design in early stages of oncology drug development – specifically, the first time they’re tested in humans – that compresses the traditional three phases of trials into one continuous trial, called an expansion cohort trial. A lot of the time and cost of clinical development is spent waiting in between the start and end of the phases of trials. Expansion cohort trials can bring efficiency to drug development, potentially reducing development costs and time. These clinical trial improvements can help ensure that innovative new therapies can be advanced efficiently to patients confronting a cancer diagnosis.

Det skjer en periodisk, men fortløpende avlesning (seamless trial). Nor96 har rett.

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