Question:
How does Phase III clinical research trials differ from Phase I and Phase II?
An Explanation Of Clinical Trials
There are four types of clinical research trials conducted on new drugs or medication. The first type of clinical research trial is known as a Phase I trial. It is completed to test the effect of a new drug on a small percent of the population, and is done on healthy individuals. The purpose of Phase I trial is to confirm a new drug's safety for human consumption.
Phase II clinical research trials are more beneficial to ALS treatment than Phase I research trials. The new drug will be tested in ALS patients to future determine its safety, and the benefits of the drug.
Phase III clinical trials are completed in specific ALS research facilities using a large number of ALS patients. Phase III clinical trials will investigate whether the new drug actually possesses the benefits found in Phase II. These benefits are tested against a placebo or another treatment, which is already in place. If Phase III trials are successful, the new drug is prepared for FDA approval. FDA approval is a lengthy process, and there is no guarantee any new drug will be approved.
Phase IV clinical research trials occur after the new drug is approved by the FDA, and during this phase, the pharmaceutical company must monitor and test the safety of the drug in the general population.
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?
