Day 68: Unblinding
After the trial comes to an end, the results are unblinded—Tim received the experimental treatment after all. This medicine is not yet available on the NHS (or from private doctors) because the evidence from the trials has not yet been approved. It will have to be analysed by the Data Manager and a Medical Statistician, who will determine whether the medicine is safe and effective.
Just because this medicine appears to work for Tim does not mean that it will be useful to enough people to make manufacture worthwhile. But if the Data Manager and Medical Statistician determine that the medicine is useful, it will go through the approval process.
The medicine needs to be approved by regulatory bodies before it is approved for general use. For a new medicine to be approved by most international regulatory bodies, it needs to show that it is safe and effective in at least two Phase III clinical trials. From pre-clinical testing to approval, the process to develop a new drug can take up to 20 years.