It is very uncertain times for our people and our planet. The arrival of the novel coronavirus or COVID-19 as it is technically referred to has hit our race hard. For starters, our planet has become so globalised and interconnected that the spread of the infection has been alarming. Long distance transport in the form of planes, trains and cars mean that the virus has been able to spread at a rate that would be otherwise impossible without modern transport systems. Other factors come into play, such as pressure on global economies, the response of different countries to the spread, and more. Tackling the virus is proving challenging, however data development companies are building SDTM Dataset platforms that are helping researchers get to grips with this new viral infection.
What is an SDTM Dataset?
All new pharmaceutical drugs have to go through the official regulation process after the company developing the drug has underwent all stages of clinical trials. When the drug is submitted to the regulator, it is submitted alongside extensive compilations of data relating to the drugs performance during the clinical trial process. This also includes vaccines, which is exactly what researchers are working flat out to develop to combat the spread of the coronavirus. The usual clinical trial process can take anywhere from 5-15 years to perform, and this is before the drug even gets to the regulators. SDTM dataset software from Formedix can drastically reduce the time it takes to get a new drug through the clinical trial process.
Coronavirus Trials
The current state of the coronavirus vaccination drug efforts are looking ok, but since the normal development timeline of up to 20 years is simply unacceptable in these circumstances, companies are exploring every avenue they can. Every drug being designed for human purposes usually goes through animal phase testing, which can easily last up to 3 years. While there is no law that requires new pharmacueticals to undergo animal testing, it is the procedure that is always followed, and the regulators very much endorse it. In what could be the first time this has ever happened, research labs in the UK are skipping animal testing after a very brief stint of tests to ensure that the new vaccines are not completely deadly.
Coronavirus Human Trials
The UK regulators have backed the decision being made by pharmaceutical companies to move onto human trials. Time is very much of the essence at the moment, and any delays in the development process will potentially cost lives. The current trajectory for the human trial timeline has been set at 1 year, which if it happens will be an extraordinary achievement. There have been several calls from the drug development companies looking for human trial volunteers, so that the tests can get underway as soon as possible. The regulators have stated that once the trails have concluded, they are going to do everything in their power to speed up the decision making process as to which vaccine will be able to be used, if any.