Clinical trials

• 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.

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.

2timothy1 7 said:

CBT-1

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:).

Hi, My son has just been diagnoises with a brain tumor grade 3/4 so found your post very interesting. Did you ever find out what the basic ingredients for CBT-1 are? Did they receive an FDA Patent. Also how did you do on the bright star? Would be very interested in hearing how you are doing. Joy.

2timothy1 7 said:

My friend is taking Doxil. I

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.

I know it has been years, but I found your post.  Did Bright Star work?  Do you know anything abuot it?  I cannot find any research on Bright Star