Diploma in Human Pharmacology (DHP) Training

In 2008, the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK (FPM) established a 2-year training programme and qualification called the ‘Diploma in Human Pharmacology' (DHP). The DHP is intended for medical doctors training to take on the responsibilities of a principal investigator (PI) for human pharmacology studies of investigational medicinal products (IMPs).

The DHP comprises supervised, structured workplace training with production of a portfolio of completed work and evidence of appropriate clinical and investigator skills. In addition trainees are required to attend three courses. These cover exploratory development of IMPs including ‘First-in-Man' studies, principles of pharmacology at an advanced level and management of adverse events in Phase I studies. At the end of the period of training, there is a two-part examination, comprising three written papers. This document describes the objectives, eligibility criteria, curriculum and syllabus of the DHP.

Objectives

The overall purpose of the DHP programme is to enable trainees to attain and demonstrate competence to serve as a PI for human pharmacology studies of IMPs, in particular those involving the first administration to humans. Such studies include those conducted in healthy and patient volunteers, 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 FPM has no authority to make the DHP a prerequisite for serving as a PI and the qualification cannot be considered as formal evidence of ‘fitness to practise'. It also does not imply that an individual is sufficiently experienced or has all the appropriate skills to serve as a Medical Director. However, the Diploma is now recognised by the Medicines and Healthcare products Regulatory Agency (MHRA) as the most appropriate qualification for accreditation of PIs in the pharmaceutical industry. Furthermore, it is hoped that high calibre doctors working in experimental medicine, translational medicine and clinical pharmacology in academia will also wish to study for the DHP as it will provide them with particular skills and competencies of direct relevance to the conduct of their research in humans.

Curriculum

The curriculum comprises the following:

1. a minimum period of two years' supervised structured training in the workplace with evidence of attainment of defined Learning Objectives provided by a portfolio and quality assured assessments;

2. acquisition and maintenance of up-to-date clinical skills including satisfactory completion of an Advanced Life Support or equivalent course;

3. attendance at two five-day DHP training courses with completion of assignments involving private study to a satisfactory standard and any other courses deemed necessary depending on the individual trainee's needs;

4. attendance at a one day DHP training course on prevention and management of adverse reactions in Phase I studies;

5. a written examination at the end of the period of training.

Diplomates will be required to have completed all elements of the curriculum to a satisfactory standard. Each of these elements is briefly described in the following paragraphs.

Supervised training in the workplace

Supervision of trainees will be performed by clinical pharmacologists with extensive experience of Phase I studies. These Educational Supervisors will be trained and accredited by the FPM, having fulfilled defined eligibility criteria. Assessments of trainee competence will be performed by the Supervisor and verified by a Senior Specialty Adviser (SSA) or the DHP Director of the FPM acting in the role of an external examiner / moderator.

Training Record

The trainee is required to maintain a training record, with documented evidence of attainment of specified curriculum learning objectives, defined in terms of knowledge, skills, attitudes and behaviours.

Portfolio

The trainee is also required to produce a portfolio of work completed in the workplace over a minimum of two years. This portfolio should be reviewed and validated by the Educational Supervisor at least three times each year and by the SSA from the FPM at least once annually. At the end of the training period, the portfolio may also be reviewed by the DHP Advisory Panel.
The portfolio should provide a comprehensive overview of work performed by the trainee. This will include a list of clinical studies in which they have been involved (tasks) and a summary written by the trainee of their activities within each task.

Full details of the DHP and how to enrol can be found here.