All early phase clinical trials have risks associated with them that require mitigation. Following not just the legislation but also all the associated guidance will help in maintaining public safety and the credibility of data.
I joined the MHRA in 2006 as a Good Clinical Practice (GCP) Inspector with promotion to senior GCP Inspector in 2010 and Lead Senior GCP Inspector in Aug 2017. I have a BSc in Chemistry and prior to joining the MHRA, spent 13 years in the Pharmaceutical industry. I started out in the pre-clinical analytical laboratory working to Good Laboratory Practice (GLP), then moved into Clinical Research and has held positions as a Clinical Research Associate (CRA)/Lead CRA and Project Manager in both the Pharmaceutical and Contract Research Organisation (CRO) environment. This has encompassed all types of clinical trials from Phase I/healthy volunteer trials through to Phase IV and has included a range of therapeutics areas, including oncology, wound management/burns, anaesthetics, urology, endocrinology and IMP devices. I have acted as GCP Operations Manager temporarily to cover maternity leave in 2016 for a year and am responsible for the GCP inspection programme and was also one of the key contributors to the GCP guide published in 2012.
Dose escalation practices should be the same regardless of whether a clinical trial involves healthy volunteers or patients. Good quality data and sound procedures are vital to ensure the safety of all trial subjects.