Lately the Clinical trials industries in the US have been greatly benefiting from the process of SDTM mapping. This article will look at the overall effects of SDTM mapping on the clinical trials industry overall and how the industry is changing as the result of a variety of different factors.
What Is SDTM Mapping?
SDTM stands for study data tabulation model. This is used within clinical trials to convert metadata into data which can then be used for the clinical trial and is kept on record. Essentially the mapping factor of SDTM is when raw data is converted into readable and accurate data which can then be kept on record .
What Are Clinical Trials?
Clinical trials are medical trials which are undertaken to perform research for a specific purpose. Often they are conducted by medical research companies or pharmaceutical companies in order to further research in a particular field. In order for clinical trials to be conducted properly and effectively they need to be regulated and conform to set standards in order to be recognised.
On on the most established and common standards which all clinical trials in the US need to adhere by is known as the cdisc standards. The cdisc standards are set of different guidlines/policies which dictate how data should be logged and the procedure required for some clinical trials.
These standards were established to ensure that data is logged accurately and correctly as well as ensuring that data protection legislation is respected throughout the clinical trials process.
How Has SDTM Mapping Assisted With Clinical Trials?
There have been a variety of different ways in which SDTM mapping has assisted with clinical trials overall. One of the main ways in which the SDTM standards have influenced clinical trials is through the mapping process. The mapping process has overall greatly improved the process of data conversion and logging overall. This has a number of inherent advantages such as:
- Faster overall logging of data
- More accurate data
- Better overall efficiency
- Less labor intensive
What External Factors Are Affecting Clinical Trials?
There are a variety of different factors that are affecting clinical trials overall. One of the main external factors that is having an a effect on clinical trials is social media and the mainstream media. Due to breaches of data protection laws in the US and the UK many people are far more sceptical overall of the activities of clinical trial companies as well as the companies they are undertaking the clinical trials for.
This bad press can have significant impact on the overall number of people participating in clinical trials as well as the value of contracts won for clinical trials overall.
Conclusion
In conclusion it is clear that SDTM mapping plays a significant role in clinical trials overall. This is mainly due to the many benefits it can bring to clinical trials companies and ease of use. It is likely that in the future many clinical trials processes could be almost fully automated in order to improve overall efficiency and accuracy