Compliance In Focus

As Brexit negotiations continue between the UK and EU, clinical research sponsors are carefully considering the future of research in the UK, as the number of clinical trials held there has begun to decrease. From an average of 806 trials a year conducted between 2009 and 2016, to 597 trials in 2017, the numbers have diminished by over 25 percent. One medical research firm based in the US has halted its clinical trial activities in the UK due to the uncertainty in approval of medicines and acceptance of data by the European Medicines Agency.

In a previous blog published towards the end of 2013 titled “Essential Documents – What Will Regulatory Binder Look Like in 5 Years?”, the blog encompasses the potential of Regulatory Binders becoming electronic. Now almost five years later, many sites and Sponsors have explored and implemented the electronic filing capability.

As many of us monitors are aware, there is high turnover in the research industry and clinical sites aren’t exempt from this. Quite often, we are likely to receive an e-mail with very little information regarding the current study coordinator or other study personnel leaving a clinical site. We may possibly receive a sentence that consists of who will be taking their place, or perhaps no notification at all.

Clinical Trials Day is celebrated around the world on or near May 20th each year in order to commemorate the day that a Scottish naval surgeon, James Lind, conducted what is often considered the first randomized clinical trial aboard a ship on May 20th, 1747. This year, Clinical Trials Day will be celebrated on Friday, May 19, 2017. In 1747, surgeon mate James Lind administered six different methods to attempt to heal sailors that were diagnosed with scurvy, with one of the methods involving oranges and lemons. This method healed the sailors, becoming a breakthrough for an intervention of scurvy, but more importantly demonstrating the potential power of a clinical trial.

Regulations are a set of legal rules that are established by a regulatory authority such as the FDA. They are required to be followed and are enforceable by legal consequences such as fines or imprisonment. The process of making a regulation can be a lengthy but important process. Federal agency priorities, industry trends, public safety, or new technology are potential reasons for creating a new rule, which can later become a federal regulation. The process of “rulemaking” is simply described: