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Clinical trials

2timothy1 7's picture
2timothy1 7
Posts: 329
Joined: Jan 2012

Could someone explain to me the different phases of clinical trials please. I think phase 1 means it was tested in a petry dish and worked. Phase 2 means it worked in mice. Phase 3: worked in humans?????

Thanks 

Tethys41's picture
Tethys41
Posts: 1053
Joined: Sep 2010
  • Phase 0: Pharmacodynamics and Pharmacokinetics
  • Phase 1: Screening for safety
  • Phase 2: Establishing the testing protocol
  • Phase 3: Final testing
  • Phase 4: Postapproval studies

Each phase has a different purpose and helps scientists answer a different question:

In Phase 0 trials are the first-in-human trials. Single subtherapeutic doses of the study drug are given to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs).[18]

In Phase 1 trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 trials, the experimental treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 trials, the treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.

In Phase 4 trials, postmarketing studies delineate additional information, including the treatment's risks, benefits, and optimal use.

Before pharmaceutical companies start clinical trials on a drug, they conduct extensive preclinical studies.

2timothy1 7's picture
2timothy1 7
Posts: 329
Joined: Jan 2012

Tethys

thanks! I knew you would know. I still think if I brought some mice and a microscope over to you , you could solve this whole OVCA thing:). 

Im thinking of taking a drug that's been through phase 3 and is awaiting NDA from FDA. It is supposed to help with chemo resistance. Made by CBA Pharma.  I'm going to take it when I go on chemo again. I have a friend who is seeing some progress with the drug.

MJensen
Posts: 93
Joined: Oct 2012

Hi
I checked out the website. Is this it? Is your friend taking it along with chemo or on it's own? Was sure if it is something you take in parallel. I know your DR is waiting for you to have some symptoms before starting chemo. Is this something you can start now before chemo?
Hope it works well for your friend and for you. Please keep us posted. I will ask my DR about it.....
Thanks for giving us info on this. Be well!!!!! Michele

2timothy1 7's picture
2timothy1 7
Posts: 329
Joined: Jan 2012

My friend is taking Doxil. I called the company yesterday. I'm waiting to hear back from them. The drug Cbt1 isn't available now. It's awaiting FDA approval. I'm going to ask them how long they think that will take. The drug my friend is on is called "bright star", from this same company. My friend takes bright star a day before chemo starts and then a few days following. 

How are you doing? I hope well.

MJensen
Posts: 93
Joined: Oct 2012

Hi,

Doxil worked for awhile with me then stopped working unfortunately.  I hope she has better success.  I will look up bright star.  Never heard of it.   I had my first treatment back on Taxol Wed.   We will see if it helps the pain.   I may have other bowel obstruction so I am on liquids and dealing with that.   Not having too much fun lately.    Hoping for better days.    Let me know if you heat anything about this CBT1.   I wonder if I could get in a clinical trial.   Hope you are doing well.   I know it's hard to wait and see what happens next.   Take care and keep me posted on any new developing options.   I feel I have run the first course and back to square one......

Thanks for checking inKiss   Michele

2timothy1 7's picture
2timothy1 7
Posts: 329
Joined: Jan 2012

Hey michele

sorry you are feeling bad. I hate this disease for all of us.

I heard back from the company yesterday. They are waiting for FDa approval on CBT-1. Who knows how long that will take. She said the drug was promising though. It's been through phase 3 clinical trials and they've been working on it for 22years now. A lot of what she said was over my head but I will try to explain best  I can.

She said you can buy, what they call bright star now. It is similar to CBT-1 but not in the purest form as the CBT-1. The lady spent a lot of time explaining it to me. you take it 3 days prior to chemo to sensitize the cancer cells to being more receptive to the chemo. Somehow, it reverses a protein pump in the cancer cell, allowing the chemo to be effective. Then  you take it 7 days following chemo as well. 

I work in healthcare field and actually met a lady who was stage 4 breast ca. Was given 2 years to live. It's been 4 and though she is still on chemo, she looks and feels good. She's been taking bright star as well. 

I will prolly look  seriously into taking this bright star once I start chemo. For now I feel good and I'm just going to try to live a normal life for a little longer:).

searchingnow
Posts: 1
Joined: Jan 2014

 

Timothy...thanks for all your posts. I have heard great things about bright star...did you end up taking it? Would love to know if you did and what benefits you received from taking it.

 

I hope this finds you well.

 

 

wholfmeister's picture
wholfmeister
Posts: 248
Joined: Dec 2012

This is similar to what was already posted as a definition of "Phases" of clinical trials.

This is from a really interesting website that talks about all the ins-and-outs of clinical trials.

"PHASE:  Food and Drug Administration (FDA) categories (http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm) for describing the clinical trial of a drug based on the study's characteristics, such as the objective and number of participants. There are five phases:

Phase 0: Exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals (for example, screening studies, microdose studies).

Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug's most frequent and serious adverse events are and, often, how the drug is metabolized and excreted.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing. These including postmarket requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drug's safety, efficacy, or optimal use.

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