Compliance In Focus

Since finalization in May of 1996, the Guideline for Good Clinical Practice E6(R1) produced by the International Conference on Harmonization(ICH), has provided clinical trial research with a set of procedural standards to ensure quality data and protection of human subjects. The document has continued to be a guiding presence in the industry over the past twenty years; however, increases in both magnitude and intricacy of clinical trials has prompted a need for modernization of the content. At the guideline’s inception, the vast majority of trials were paper-based, which is in stark contrast to the technological focus of today’s trials. The industry has also experienced a move toward risk-based methodologies to improve efficiency of the rapidly growing trial landscape. The universal shift toward electronic records, data capture systems and risk-management has led to changes in the conduct of trials not only to clarify the processes, but to redefine the responsibilities of the individuals executing them. For all these reasons and more the ICH has rolled-out the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2).

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the past couple calendar years.

Back in the early 1960’s, public perception of clinical research began to take a turn as talks and frightful images of the Thalidomide tragedy gained national news. In this case, Congress managed to pass new legislation to attempt to mitigate the issue (the Kefauver-Harris Amendment, respectively), but who couldn’t be left wondering “What’s the next terrible course of events that will happen?”