Understanding clinical trial phases
As you investigate your vitiligo it will become apparent that you also need to understand the pharmaceutical industry and how it works. A key part of this is the different phases of clinical trials and what they imply.
Phase 0: Pre clinical development This is where a “lead compound” is identified that could be useful in treating a specific condition. no human testing happens at this stage. Interestingly this phase can sometimes last up to 6 years and the cost goes into the hundreds of millions of dollars.
Phase 1: Clinical trial starts: Here the company files an investigational New Drug (IND) application which allows them to begin testing on humans. There are usually less than100 people involved and it takes up to 2 years costing between 1 and 6 million dollars. The point of this phase is to identify the safe dosage range and side effects.
Phase 2: Here the drug is given to a slightly larger sample size usually between 200/300 people who have the condition the drug is trying to address. This phase is a key step and lasts around 2 years with a cost of up to 20 million dollars.
Phase 3: Now the drug has momentum behind it. This is where it is given to a much larger group of patients across multiple countries and clinics. The drug is compared to existing drugs. The cost here can go up to 100 million dollars and can last up to 4 years.
Regulation: When phase 3 is complete the company then files a New Drug Application (NDA) or similar application depending on the country. Experts review the data and evidence and decide if the drug is allowed to be sold or not. This phase can take around 2 years and costs only a filing fee of around 2 million dollars.
Knowing these phases allows the investigator to separate the reality form the hype when reading headlines about new drugs. It also allows you to make educated decisions on if a treatment is correct for you or not in your journey.
