Question:
How does Phase III clinical research trials differ from Phase I and Phase II?
Una explicación de los ensayos clínicos
Hay cuatro tipos de ensayos clínicos llevados a cabo la investigación de nuevos fármacos o medicamentos. El primer tipo de ensayo de investigación clínica se conoce como un ensayo de Fase I. Se completa para probar el efecto de un nuevo fármaco en un pequeño porcentaje de la población, y se realiza en individuos sanos. El propósito de ensayo de Fase I es para confirmar la seguridad de un medicamento nuevo para el consumo humano.
Los ensayos de fase II de investigación clínica pueden ser más favorables a la ALS tratamiento que los ensayos de fase I de investigación. El nuevo medicamento se pondrá a prueba en pacientes con ELA para determinar su seguridad futura, y los beneficios de la droga.
Fase III de ensayos clínicos se realizan en determinados centros de investigación de ALS con un gran número de pacientes de ELA. Fase III de ensayo clínico investigará si el nuevo medicamento en cuestión posee efectivamente los beneficios encontrados en la Fase II. Estos beneficios, se analiza una placebo u otro tratamiento, que ya está en su lugar. Si ensayos de fase III tienen éxito, el nuevo medicamento está preparado para la aprobación de la FDA. aprobación de la FDA es un proceso largo, y no hay ninguna garantía de cualquier nuevo medicamento será aprobado.
Los ensayos de fase IV de investigación clínica se producen después de que el nuevo medicamento es aprobado por la FDA, y durante esta fase, la compañía farmacéutica debe supervisar y evaluar la seguridad del fármaco en la población general.
ALS Frequently Asked Questions
Has there been a lot of research completed on ALS?
My doctor has prescribed Rilutek. How does this drug function?
Has the ALS Association funded any research?
Can you provide more details about TREAT ALS?
Should I consider participating in ALS Research?
How does Phase III clinical research trials differ from Phase I and Phase II?
Which centers are working on ALS research?
Has research been previously completed on ALS?
Are there any upcoming trials to look forward to?
Help me find information on ALS Research?
Which diseases are the differential diagnosis for ALS?
I have been feeling weaknes in my body. Could it be ALS?
I have been referred to a neurologist. What can I expect during this visit?
How important is the neurological exam in diagnosing ALS?
Which laboratory tests are necessary to diagnose ALS?
I am scheduled for a CSF analysis. What does this test mean?
Why did the neurologist schedule an MRI for me?
I have heard an Electromyography is important in diagnosing ALS. Can you explain it a little more?
I wonder if bone cancer is causing my symptoms?
Are there more than one form of ALS?
Tell me more about Sporadic ALS? How common is it?
What are many chances of getting ALS if my dad or mom had it?
Is Guamanian ALS only located in Guam?
How do the different forms of ALS differ?
Who first made wrote details on ALS?
What are the incidence and prevalence rates of ALS?
Is ALS known as any other names?
What is Amyotrophic Lateral Sclerosis (ALS)?
What symptoms can I expect during the early stages of this disease?
I developed muscle weakness and was later diagnosed with ALS. Is it commmon to feel this weak?
What symptoms can I expect with upper motor neuron involvement?
What symptoms can I expect with lower motor neuron involvement?
Can I expect any other symptoms as I battle ALS?
Which symptoms am I not likely to experience with ALS?
What is the difference between Limb-onset ALS versus Bulbar-onset ALS?
"Spastic bulbar palsy" sounds complicated. What is it exactly?
What can I expect during the end stages of ALS?
Is Rilutek the only medication used in ALS?
Will I benefit from physical therapy as an ALS patient?
Is occupational therapy necessary when diagnosed with ALS?
I am noticing problems with my speech. Can a speech pathologist help me?
My father who has ALS has stopped eating large meals. What do I do?
I have just been diagnosed with ALS and need to talk to someone. Who do I talk to?
I have heard I will develop problems with breathing. Which type of doctor do I see?
What is the purpose of the ALS C.A.R.E. database?
