Drug Testing & Licensing in Clinical Trial Process
All new drugs & treatment should thoroughly follow the testing procedures before they are licensed & used on patients. A new drug is initially studied in the laboratory & if it looks promising enough it is then tested among identified human subjects and once this extensive test is done and it does comply with the health & safety standards without any specific side effects, then the final process of licensing could happen accordingly.
There is no typical length of time it takes for a drug to be tested and approved. It might take 10 to 15 years or more to complete all 3 phases of clinical trials before the licensing stage. But this time span varies a lot. Some of the main factors which affect the time taken by the drug to be licensed are
The type of Cancer
Clinical trials for rarer cancer take a longer time because of fewer availability of patients also known as test subjects. Research teams from several countries may collaborate to ensure enough patients making the trials longer to organize & set up.
The type of treatment
Trials that use new methods for giving the treatment such as a new type of radio therapy may take a long to set up & run accordingly. This happens because the research team needs specialist equipment & extra training. These trials can only stand & run in a small number of hospitals compared to trials using standard ways of giving treatment.
The type of Clinical Trial
Some trials look at ways to prevent cancer or ways in which cancer could be screened. Screening means testing for cancer in people who does not have those symptoms before. People who join these trials have never been diagnosed with cancer. The research team often follows them for years to see who develops cancer & who doesn’t. Then the comparison of trial group happens to see if the particular treatment can help prevent cancer or whether it could diagnose early. These trials take a long time to get results compared to treatment trials. Sometimes it will take years to see clear difference in the no. of people in different groups.
The Number of Patients Needed
Finding the right number of respondents who would be subjected to tests by the clinical trial experts is of prime importance. If lesser number of test subjects are used then the test results cannot be considered reliable. The number depends on the how many treatment groups are needed and the exact inference that the research team wants to find.
Finally let’s discuss about follow up period
Research team here looks at how well people are doing after they have the treatment as a part of the trial. This helps researchers to analyze the effects of treatment on a longer time framework and its long term side effect if any. These are some of the main reasons why clinical trial could take a very long time period before the drug is licensed & used for patients.