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Adam standards are a set of different guidelines which we will discuss and examine in this article. Adam standards specifically apply to clinical trials as they partly influence how the trials are performed overall.

Why Are Clinical Trials Regulated

There are a number of reasons as to why clinical trials are regulated. One of the main reasons clinical trials are regulated is to ensure the safety of those taking part in clinical trials. America has a chequered history with medical experiments and in the 50s right up to the 70s/80s very controversial and immoral experiments were taking place. In later years there was a shake up in the legislation as well as policies and procedures that have been put into place in order to safeguard people.

How Safe Are Clinical Trials Now?

Clinical trials now compared to what they were previously are almost night and day. Now any organisation undertaking a clinical trial is obliged to undertake research prior to the trial as well as ensure that all safeguards are in place to protect those participating in them. As well as safety measures there have also been a number organisational methods put into play in order to ensure that data is noted accurately and effectively. One of the most familiar forms of this is that cdisc standards. Cdisc standards are a set of policies which ensure that data is taken down correctly. One of the main benefits of this is that data is submitted and the time taken to collate the data is significantly faster.

Adam Standards

Adam standards are a set of policies not dissimilar to cdisc strands which set out fundamental guidelines for organisations or individuals to follow. Listed below are some of the fundamental key principles of adam standards.

• Allows for effective and accurate recording as well as analysis of clinical trials.
• Provide clear concise information
• Well known throughout the industry and a hallmark of professionalism

What Challenges Are Facing The Wider Industry?

At present there are variety of different issues which are facing the industry. One of the most pressing issues is of course the issue of Brexit. The problem at the moment is that Brexit is creating uncertainty within the industry which is leading to less medical and bio companies undertaking research or trials until they can be sure that they have a market in the UK or are informed of what trading tariffs may or may not be inflicted on drugs and medicines going in or out of the UK. The longer the uncertainty surrounding this political issue goes on , the more damaging for the UK it will be as well as the pharmaceutical and clinical trials industries.

Conclusion

Overall to conclude it is important to note that adam standards play an important part in the clinical trials industries and is one of the key components to a successful clinical trial. It is also apparent that outwith the US more needs to be done by the UK and EU to ensure that there is some form of clarity surrounding brexit and the future of Britain.