Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines.
Health Aff (Millwood)
; 37(5): 724-731, 2018 05.
Article
en En
| MEDLINE
| ID: mdl-29733717
ABSTRACT
Precision medicines can benefit patients by increasing the probability of a successful treatment response in selected patient populations. The potential for more immediate signals of efficacy during clinical trials suggests such medicines will reach the market more rapidly than traditional drugs will. Using data from the Food and Drug Administration (FDA), we examined the regulatory review and pivotal trial characteristics of precision medicines. We found that in the period January 2013-June 2017, precision medicines were developed and reviewed almost two years faster than nonprecision medicines. In addition, approximately 48 percent of the precision medicines in our study qualified for the FDA's breakthrough therapy designation. Precision medicines were also approved based on fewer pivotal trials with fewer patients, and the trials were less likely to be randomized, blinded, or controlled with either an active or placebo comparator.
Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
United States Food and Drug Administration
/
Productos Biológicos
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Aprobación de Drogas
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Medicina de Precisión
Tipo de estudio:
Clinical_trials
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Observational_studies
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Prevalence_studies
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Prognostic_studies
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Risk_factors_studies
Límite:
Female
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Humans
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Male
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Health Aff (Millwood)
Año:
2018
Tipo del documento:
Article
País de afiliación:
Australia