The Diploma in Experimental Therapeutics (DET) is an 18-month training programme and qualification. The DET programme is intended for physicians conducting Phase I/II studies within their particular specialty. The overall purpose of the DET programme is to enable trainees to attain and demonstrate competence to serve as a principal investigator (PI) for exploratory clinical studies of investigational medicinal products (IMPs) within their area of specialisation. Such studies will typically involve patients, in which the primary end-points are tolerability, pharmacokinetics and evidence of drug effects on biomarkers of efficacy and safety. The training in practical aspects of working as a PI is underpinned by a knowledge of the scientific basis of drug action.
The DET programme includes supervised, structured workplace training with production of a portfolio of completed work, reflective learning and evidence of appropriate clinical and investigator skills. In addition trainees are required to attend three courses. These cover exploratory drug development including ‘first-in-human’ studies (5 days) and drug development pharmacology (5 days) at an advanced level. The two 5-day courses are run at King’s College London. In addition to post-course tests and assignments, there is also an exam administered by FPM.
DET is aimed at doctors working in contract research organisations and also NHS doctors working in various specialities such as oncology, rheumatology, experimental medicine and clinical pharmacology, who are involved in early clinical trials of investigational medicines.