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.
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.