The recent arrival of the novel coronavirus or COVID-19 as it is technically referred to has created great instability for people all around the world.  Tackling the virus is proving challenging, however data companies that build SDTM dataset platforms are helping researchers on the front line of understanding this virus so that they can create a vaccine. Although a viable vaccine is still a while away, speeding up the process of creating one is incredibly important at this stage, as every week it takes to create a virus, more and more people will die.  Finding a vaccine quickly and safely is the top priority right now for research labs all around the world.

SDTM Dataset Software Explained

All new drugs and vaccines must go through the official regulation process after the company developing the drug has underwent the stages of clinical trials.  When the drug is submitted to the regulator, it is submitted with extensive compilations of data relating to the drugs characteristics during the clinical trial process.  This very important clinical trial process can take anywhere from 5-15 years to complete, and this is before the drug even gets to the regulators.  SDTM dataset software can essentially drastically reduce the time it takes to get a new drug through this process, which means it can hit the shelves much faster.

Speeding Up Data Logging

The great thing about utilising these special types of software is that they can already be programmed to receive data before the trails actually take place.  Then once the data starts flowing in, the software can automate the compilation of the dataset.  This not only drastically speeds up the overall process, but it also means that the software can catch errors before they go to the regulators.

Unusual Circumstances

One thing that happened in the UK recently has completely went against the usual procedure for creating new drugs and vaccines.  A UK lab has decided to cut animal testing short, and move straight onto the human clinical trial process.  While this is highly unusual, it highlights the urgency of this completely unprecedented issue.  Experts are saying that if the standard route is followed, a vaccine might not be ready for another 10 years.  At the current rate of infection, this is just to far away, so anything that can be done to cut corners is being considered.  This means that a new approach was necessary in order to get the whole process down to what experts are hoping will be a one year timeline. 

A New Approach

There are sceptics that are saying that rushing an unproven vaccine through the clinical trials process is asking for trouble.  However, experts are saying that, given our current circumstances, all avenues must be explored.  If this one year timeline is going to be achieved, we have to make some serious changes to the way that we conduct medical trials.  It is clear that in our current situation, where we were very quickly overwhelmed by a completely new virus, we are going to have to go against the normal way of doing things.