Let's Not Put All Our Eggs in One Basket  

Oleh:

Hunter, David J. ; Agostino, Ralph B. D

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The New England Journal of Medicine (keterangan: ada di Proquest) vol. 373 no. 08 (Aug. 2015), page 691-693.

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Perpustakaan FK Nomor Panggil: N08.K Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Medical progress in the second half of the 20th century was largely defined by the rise of evidence-based medicine, in which adequately powered phase 3 randomized, controlled trials (RCTs) provide key evidence regarding the efficacy and safety of drugs. History is littered with examples of drugs that looked promising on the basis of the results of small phase 1 and phase 2 studies but that failed in phase 3 studies. Regulatory agencies such as the Food and Drug Administration (FDA) impose strict rules on the design and analysis of trials conducted by companies seeking approval for new drugs. This edifice has been put in place both to avert disasters such as dissemination of drugs with severe side effects and to establish efficacy so that physicians can prescribe medicines with knowledge of their indications and likely effects.

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