Ensaio clínico: Diferenzas entre revisións

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Breogan2008 (conversa | contribucións)
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Breogan2008 (conversa | contribucións)
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Depending on product type and development stage, investigators initially enroll volunteers or patients into small [[Pilot experiment|pilot studies]], and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or [[multicenter trial|multiple centers]], in one country or in multiple countries. [[Clinical study design]] aims to ensure the [[Validity (statistics)|scientific validity]] and [[reproducibility]] of the results.
 
Costs for clinical trials can range into the billions of dollars per approved drug.<ref>{{cite journal | doi = 10.1016/j.jhealeco.2016.01.012| pmid = 26928437| title = Innovation in the pharmaceutical industry: New estimates of R&D costs| journal = Journal of Health Economics| volume = 47| pages = 20–33| year = 2016| last1 = Dimasi| first1 = Joseph A| last2 = Grabowski| first2 = Henry G| last3 = Hansen| first3 = Ronald W| hdl = 10161/12742| hdl-access = free}}</ref> The sponsor may be a governmental organization or a [[Pharmaceutical industry|pharmaceutical]], [[biotechnology]] or [[medical device]] company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a [[contract research organization]] or a central laboratory. Only 10 percent of all drugs started in human clinical trials become [[approved drug]]s.<ref>{{cite news|last=Emanuel|first=Ezekiel J.|author-link=Ezekiel J. Emanuel|date=September 9, 2015|title=The Solution to Drug Prices|newspaper=[[The New York Times]]|url=https://www.nytimes.com/2015/09/09/opinion/the-solution-to-drug-prices.html|quote=Of the drugs started in clinical trials on humans, only 10 percent secure F.D.A. approval.{{nbsp}}...|name-list-style=vanc}}</ref>
 
== Notas ==