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Diploma in Experimental Therapeutics

The Diploma in Experimental Therapeutics (DET) is intended for physicians conducting Phase I/II studies predominantly in patients within their clinical specialty, such as oncology or rheumatology, in a hospital clinical research facility.

Overview

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.

Programme structure and curriculum

Supervised workplace training

  • A minimum period of 18-months’ supervised, structured training in the workplace with evidence of attainment of defined learning objectives provided by a portfolio of completed work with reflective learning and quality assured assessments of appropriate clinical and investigator skills.
  • Supervision of trainees is performed by an Educational Supervisors who will usually be a senior consultant in a related specialty with extensive experience of Phase I/II studies.  Assessments of trainee competence with attainment of learning objectives are performed by the Educational Supervisor.
  • The trainee is required to maintain a training record, with documented evidence of attainment of the specified learning objectives, defined in terms of knowledge, skills, attitudes and behaviours.
  • The trainee is required to produce a portfolio of work completed in the workplace over a minimum of 18-months. The portfolio should provide a comprehensive overview of work performed by the trainee with evidence of reflective learning about each study in which they have been involved.  It should be reviewed and validated by the Educational Supervisor at least three times each year.  At the end of the training period, the portfolio will be reviewed by members of the DET Advisory Group.

Maintaining clinical skills

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

Courses

  • Attendance at two five-day courses run at King’s College, London with satisfactory completion of post-course tests and assignments. These cover exploratory drug development including ‘first-in-human’ studies and drug development pharmacology at an advanced level.
  • Any other courses deemed necessary depending on the individual trainee’s needs.

Examination

DET candidates take the Certificate in Human Pharmacology exam which is administered by FPM. The exam is a multiple-choice question paper focusing on scientific knowledge from across the syllabus.

In addition, those who have successfully completed the DET curriculum will be required to have gained a Certificate of Completion of Training (CCT) in their specialty before the Diploma can be awarded.

Further information on the course programme is included in the DET Candidate Guide and Syllabus (pdf).

Eligibility

Information on eligibility is included in the DET Candidate Guide and Syllabus (pdf).

Fees

The fee for enrolling on the DET programme is £2500 which covers administration of the programme and the examination. Fees for the teaching and materials associated with the DET courses are charged separately by the provider, King’s College London. The fee does not include travel or accommodation expenses.

Programme registration

You can register for the programme at any time and the first step is to submit the completed CV template (doc) to exams@fpm.org.uk. The CV will be reviewed for eligibility and if provisionally approved you will be sent an enrolment pack. The enrolment process is summarised here (doc).

Exam registration (for enrolled candidates only)

DET candidates take the Certificate in Human Pharmacology exam. The exam scheduled for 30  March 2020 has been postponed to the Autumn. A new exam date will be announced as soon as possible. Please contact us at exams@fpm.org.uk if you have any questions.