Within the US clinical research and medical trials for many years have been shrouded in secrecy and in many cases condemned for being inhumane or inaccurate. However in the last 20 years major changes have been made within the industry in order to protect people’s data , health and overall welfare. Through this article we will examine what makes the adam dataset so important and what effect it has on clinical trials across the states.
Introduction To Adam Dataset
In 2009 the clinical data interchange standards association introduced the adam dataset. This dataset was made to help consolidate data and ensure that standards are followed when clinical trials are undertaken. The adam dataset has a number of different core key principles of which it is based on.
- Ready to be analysed
- Traceable between analysis data and source data
- Readily usable by software tools
- Ensures clear and open communication
Past Mistakes In The US medical Industry
The US is unfortunately well known for human rights abuses and medical experiments that breached the dignity and welfare of many. One of the most famous and renowned experiments was known as the Stanford prison experiment. During this experiment several willing participants were given the role of prisoner and several others the role of prison guards. The experiment had to be stopped after only a matter of days as the prison guards were becoming increasingly hostile and nefarious towards the prisoners. This experiment was not well regulated or subject to many standards.
Why Data Is Important
Data is important to not just individuals but organisations and businesses. Data can be bought , sold and used for future medical research. However failure to use data with someones consent or unauthorised access to data is a gross breach of trust and amounts misconduct amongst other crimes. Part of the reason the adam dataset was created was to continue from the CDISC procedures and create a clear and robust set of policies for clinical research companies.
How Has Society Changed?
Society has changed in many different ways since halfway through the 20th century. Any medical experiments or clinical research trials are now subject to strict procedures and regulation such as the CDISC standards model. Furthermore societies attitude towards people with mental illnesses is far more sympathetic and understanding than it was in previous generations. This is in part due to increasing research into mental health , more people opening up about mental health and inidividuals being held to account for their actions.
Ultimately the society present in the US around the era of mass unregulated experiments and medical research is one which is completely different to that we live in today. The establishment of support groups in conjunction with data standards authorities are now present to ensure that the same abuses do not take place again.
Conclusions
Overall it can be concluded that the implementation of the adam dataset in conjunction with CDISC standards have been very positive for the US medical research industry. Without these standards in place the medical research industries might not have been the same as we know them today.
