'Audit-proofing' Your Trials

Mike Hennessy Jr, President and CEO, MJH Life Sciences^®

For this combined July/August issue of Applied Clinical Trials, it’s back to school for clinical trials professionals! We are focusing on good clinical practice (GCP) and how to “audit-proof” your clinical trials. While keeping tabs on GCP has always been important, the task has only gotten more complex in recent years. The increased adoption of decentralized clinical trials (DCTs) and technological solutions are among the reasons for this. It is crucial to remain compliant in an area that is highly regulated.

This is also our first issue since our editors attended the 2023 DIA Global Annual Meeting in Boston, MA, in late June. A number of themes emerged through the sessions and interviews, including patient data, regulatory compliance, and diversity. You can visit our conference coverage page to check out our latest event show coverage in its entirety.

For this issue’s main feature, regular contributor and freelance writer Christine Bahls gives an overview of how the industry can raise the bar in GCP adherence. Key industry leaders provide insights on improving training and real-time application, as the list of GCP items is only proliferating amid the rise of digitalization. The end goal is avoiding compliance pitfalls in conducting clinical studies.

Our next contributed feature focuses on the International Council for Harmonization’s (ICH) Good Clinical Practice (GCP) E6 guidance. Through the COVID-19 pandemic, drug developers learned a lot from the spike in DCTs—the practical challenges and benefits. However, at the time, ICH’s GCP E6 R2 guidance was out of date and did not address DCT elements. With the draft R3 version being issued in May, there are a new set of principles when it comes to DCTs that sponsors must support their investigators and sites in carrying out.

This issue’s trio of feature articles concludes with a piece on eSource interoperability in the transfer of data from electronic health records (EHRs) to electronic data capture (EDC). Through a live pilot study, embedded within a Phase III cancer trial, experts were able to conclude that the industry is indeed taking steps toward establishing EHR-to-EDC as a highly effective option for clinical trial data requirements.

Thank you for reading.

Mike Hennessy Jr. is the president and CEO of Applied Clinical Trials' parent company, MJH Life Sciences^®