SDTM automation stands for Study Data Tabulation Model and refers to a standard method for organising human clinical trial data. It is also used by companies who are submitting food product applications to a regulatory body like the FDA. This method of compiling dataset is usually a mandatory requirement when submitting these types of data, so anything that can be done to speed this process up can usually save companies a lot of time and money.
SDTM Automation And How It Works
As the name suggests, SDTM Automation is the process of automating the datasets so that they can be compiled quickly and effectively. Some companies even claim that the automation software can begin to compile the SDTM results before hard data is even collected. This is a very appealing prospect for research organisations and product developers as it not only speeds everything up, but it also offers insights into the nature of the data.
Billion Dollar Industry
Medical science needs vast resources and cash flow in order to do the work they do. Getting a pharmaceutical drug for example to market can often take around 10 years and the average cost of this process is $2.6 billion, meaning that these companies must be very careful when designing and selecting potential medicines and drugs. For a pharmaceutical drug to reach this stage, it has to pass many long and rigorous tests and only around 1 in 5000 of these will actually make it to market.
Medical Trial Process
Drugs for human consumption usually go through a very similar process when it comes to testing and getting to market. This process starts with laboratory studies, with animal studies in conjunction with this in order to test around 5000 compounds to record their effectiveness. This will usually take around 6 years and its main purpose is to assess the safety of the compounds and its suitability for biological application. It is commonly known as the preclinical stage and consists of the manufacturers completing and purifying the compounds in the lab before limited animal testing takes place.
Once this is completed, already half of our standard approval timeline has gone, and only then do we move onto human trials. These happen in 3 stage clinical trials, starting with 20-100 volunteers in phase 1, then moving to 100-500 patient volunteers in phase 2, before getting to stage 3 with 1000 to 5000 patient volunteers. During this process, 5 compounds will be tested of the original 5000, and this entire process can take anywhere from 4-6 years.
SDTM Automation To Speed Up Testing
After all the clinical trials are completed, the data must be compiled in an SDTM format and given to the FDA so the review and approval process can begin. Only one drug compound will be approved out of the original 5000, so the cost and time involved is enormous for the end result. This is where SDTM automation software can streamline the entire process and knock a few months off from each of the stages of testing, which can accumulate and overtime save a considerable amount of time and money.