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Desarrollo de Fármacos

Anna Sladky1, Jenny Echevarria Medina1, Patricia Lowe1

  • 1USF Health Byrd Alzheimer's Institute, Tampa, FL, USA.

Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 25, 2025
PubMed
Resumen
Este resumen es generado por máquina.

Una unidad móvil de ensayos clínicos mejoró la visibilidad y participación en la investigación del Alzheimer, pero enfrentó costos significativos y desafíos logísticos, lo que llevó a su retiro. El uso futuro implica transferir la unidad a otro equipo.

Palabras clave:
ensayos clínicos móvilesinvestigación de la enfermedad de Alzheimerdesarrollo de fármacossalud móvilensayos clínicos

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Área de la Ciencia:

  • Ensayos Clínicos
  • Enfermedades Neurodegenerativas
  • Salud Móvil

Sus antecedentes:

  • Se estableció una unidad móvil de ensayos clínicos en 2016 para impulsar la inscripción en ensayos clínicos de la enfermedad de Alzheimer en Florida.
  • El objetivo era aumentar la participación de la comunidad y el acceso a oportunidades de investigación.

Objetivo del estudio:

  • Evaluar los éxitos y fracasos de una unidad móvil de ensayos clínicos.
  • Analizar la viabilidad financiera y los desafíos operativos.
  • Determinar el futuro de la unidad móvil.

Principales métodos:

  • Revisión retrospectiva de las operaciones de la unidad, incluidos los éxitos y fracasos.
  • Análisis de los ingresos frente a los gastos.
  • Evaluación de los comentarios de los participantes y el interés de los patrocinadores.

Principales resultados:

  • Resultados positivos: Mayor visibilidad comunitaria, comentarios positivos de los participantes, aumento de solicitudes de citas y algunos aumentos en la inscripción en ensayos.
  • Desafíos significativos: Altos costos operativos (gastos de >100.000 $ frente a ingresos de 27.000 $), problemas de mantenimiento, vacilación de los patrocinadores (especialmente para ensayos de anticuerpos monoclonales), obstáculos regulatorios (formularios 1572 de la FDA) y complejidades logísticas.
  • La unidad se retiró debido a la insostenibilidad financiera y las barreras operativas, particularmente con los tipos de fármacos de ensayos en evolución.

Conclusiones:

  • Las unidades móviles de ensayos clínicos ofrecen beneficios para la extensión comunitaria y los estudios observacionales.
  • Los costos operativos, el mantenimiento y la falta de financiación/flujos de ingresos constantes plantean desafíos significativos.
  • La unidad semimóvil se retiró debido a problemas financieros y logísticos, con planes de transferirla a otro equipo institucional.