This whole-time non-resident post will enable a Specialist Trainee to develop his/her clinical, teaching and research skills, and to gain experience in reporting research in national/ international meetings and journals. In addition, accreditation in General Internal Medicine and Clinical Pharmacology & Therapeutics will be achieved, with experience of basic pharmacology and clinical trials. The postgraduate dean confirms that this placement and/or programme has the required educational & Dean’s approval.

Responsible to:

Professor L L Ng (Pharmacology Group, University of Leicester)

Professor H. Thurston (Head of Service) & Dr K. Blanshard (Clinical Director)

Responsible for: Clinical activities within the Cardiovascular Unit at the Leicester Royal Infirmary, undergraduate teaching and personal research programme.

The rotation will be based predominantly in the Leicester Royal Infirmary and will rotate to a drug industry partner (eg. Roche Pharma or Astra-Zeneca) for a period of 6 months to 1 year depending on the trainee’s requirements. This will enable trainees to obtain experience in an industrial setting, gaining expertise in phase I and II studies, knowledge of pharmacokinetics, drug monitoring, drug design and structure activity studies.

An example of the rotation is as follows:-

Year 1 G(I)M Leicester Royal Infirmary

Year 2 G(I)M with CPT, Leicester Royal Infirmary

Year 3 CPT research, Leicester Royal Infirmary

Year 4 CPT research Leicester Royal Infirmary and CPT training, industry partner

Year 5 G(I)M with CPT, Leicester Royal Infirmary

The Trainee will have a Personal and Professional Development Plan or Learning Contract with regular appraisals.

The University Hospitals of Leicester NHS Trust

The University Hospitals of Leicester NHS Trust came into existence in 2000 and comprises all three main hospitals in Leicester – the Leicester Royal Infirmary, the Leicester General Hospital and the Glenfield Hospital. Together they provide comprehensive hospital care to the people of Leicestershire & Rutland.

There has never been a more exciting time to be involved in the delivery of healthcare in Leicestershire & Rutland. Healthcare in the two counties that the University Hospitals of Leicester NHS Trust serves will be transformed and modernised over the next 10 years under the Pathway project. This capital project, which will be one of the biggest in the country, will see significant positive changes at the Trust’s three prestigious teaching hospitals including the creation of a centre of excellence in the delivery of planned care and rehabilitation at the Leicester General Hospital and the concentration of acute services on the Leicester Royal Infirmary and Glenfield Hospital sites.

The newly established Strategic Health Authority (commenced 1 April 2002) covers Leicestershire, Northamptonshire and Rutland and serves a population of in excess of 1.5m.

The counties of Leicestershire & Rutland are served by two Primary Care Trusts/Groups with each having a defined group of services for which it acts as host and this includes responsibilities for the community hospitals within the county boundaries.

The Leicestershire Partnership NHS Trust (commenced 1 April 2002), established from the former mental health and learning disabilities service, completes the health services picture for the two counties.

The Leicester Royal Infirmary NHS Trust is an acute hospital located approximately one mile from the city centre. It contains 1,141 beds covering all of the major specialties and in addition is a major acute teaching hospital. The hospital contains the only Accident and Emergency unit in the district.

The Sandringham Building which opened in 1980, provides Pathology, Medical Physics and Physiological Measurement departments, and separate, purpose built laboratories for Haematology, Histopathology, Chemical Pathology and the Public Health Laboratory Service.

The Robert Kilpatrick Clinical Sciences Building of the University of Leicester is situated on the Royal Infirmary site and provides offices and research laboratories for the University Department of Cardiovascular Sciences (Pharmacology and Therapeutics Group).

Cardiovascular Unit, Leicester Royal Infirmary

The Cardiovascular Unit (CVU) at the Leicester Royal Infirmary comprises 21 beds, of which 9 are high dependency beds and the remainder are “step-down” beds. The unit is one of the busiest cardiovascular units in the UK, with over 1200 admissions a year for acute coronary syndromes, heart failure and arrhythmias. It is also the base for many phase III clinical trials in cardiovascular patients. The consultants include:-

Prof. David Barnett Professor of Clinical Pharmacology

Prof. Leong L. Ng Professor of Medicine & Therapeutics

Dr. Iain B. Squire Senior Lecturer in Clinical Pharmacology

Dr. Joan E. Davies Consultant Physician

Dr. Adrian Stanley Consultant Physician

General (I) Medicine wards at Leicester Royal Infirmary

Amongst the other wards involved with trainees in this post will be general internal medicine wards at the Leicester Royal Infirmary, including wards with patients with diabetes and elderly patients. Such patients often have complex therapeutic needs and great potential for adverse reactions.

Main Clinical Duties and Responsibilities

The Specialist Trainee will be expected to participate in clinical activities, teaching and research as detailed below.

Clinical Duties

The Specialist Trainee will have specific clinical responsibilities in cardiovascular medicine and participate in the medical on-take rota, which is currently a full-shift system. The Pharmacology and Therapeutics Group provides services on the Cardiovascular Unit at the Leicester Royal Infirmary (where the Specialist Trainee will gain experience in predominantly cardiovascular disease management). In addition, the post rotates onto a general medical ward. The Pharmacology Group provides specialist services in ischaemic heart disease and heart failure at the Leicester Royal Infirmary, based predominantly on the cardiovascular unit.

A digital echocardiography service with network links to the Glenfield Cardiology site has also been set up, with investigations including stress echocardiography, trans-oesophageal echocardiography and more recently, the introduction of 3-D echocardiography.

The post is fully accredited with the JCHMT for training in Clinical Pharmacology and General Internal Medicine (G(I)M). It is envisaged that this currently advertised post would interact closely with the existing Specialist Trainee/lecturer in Clinical Pharmacology with rotations between General Medical and Cardiovascular Unit wards and would have a timetable of similar balance to this post.

a) G(I)M Programme

This consists of training, which rotates between the cardiovascular unit (incorporating the coronary care unit) and one of the general medical wards, which has predominantly patients with cardiovascular disease as well as general medical patients.

Out patient clinics that could be incorporated into the training programme include the following: -

heart failure clinic

secondary coronary prevention clinic

general medical clinic

hypertension clinic

On the coronary care unit, there are daily consultant ward rounds including weekends. Thus, well over half of supervised ward rounds will be led by consultants with a Clinical Pharmacology background. On the general medical ward, there are usually 2 consultant ward rounds per week. The specialist Trainee is expected to lead at least 1 ward round per week in either of these units, and should supervise the junior staff on these units (which include an SHO and an HO). He/she is also expected to provide cardiovascular or therapeutic opinions on ward referrals.

There is a resident on-call commitment to medical takes at the Leicester Royal Infirmary with a full shift rota on a 1:5 or 1:6 basis. There will be periods of night shifts as well. Shifts run from 9am to 10pm and 10pm to 9am. Each shift consists of 2-3 Specialist Trainees, 2-3 FY1 and FY2, and the Specialist Trainees being the most senior residents are expected to supervise the junior members.

A timetable for the Specialist Trainee post (whilst in G(I)M training) is given below as an example.

	AM	PM
Monday	Heart Failure Clinic or Consultant Ward round	In patient ward round
Tuesday	Consultant Ward round	Research/Audit afternoon
Wednesday	Consultant Ward round	Post infarction and Secondary Prevention Clinic OR general medical clinic
Thursday	Consultant Ward round or Hypertension clinic	Research afternoon
Friday	Consultant ward round	Undergraduate Bedside Teaching

Ward rounds in the above timetable refer to those on the Coronary Care unit where there is a daily consultant ward round. There may be opportunities to obtain experience on other general medical wards.

Acute admissions to the Medical Unit usually take place via the Acute Medical Unit (AMU - based on two 30-bed wards, AMU 15 and AMU 16). After assessment by the Consultant on-call, patients may be discharged, transferred to the care of an appropriate general medical ward or specialist team or remain within the AMU wards if only short admission for stabilisation or results of tests is required. In times of bed shortage, patients may also be transferred or discharged from AMU between 5pm and 8am after review by the Specialist Trainee on call.

Consultants are responsible for all Admissions on AMU 15 and AMU 16 in rotation working in blocks of 2 day weekends (Sat/Sun) or 5-day week (Mon-Fri) - during which they are based on AMU throughout the working day and on-call from home at night. A daily 8 am ward round begins with the night time on-call team and assesses patients who have been admitted overnight, or required acute management overnight. The remaining patients are then reviewed later in the morning with the daytime on-call team. The AMU 'Core Team' of consultants work on AMU between 1 in 5 and 1 in 8 weeks - other consultants approximately 1 in 24 weeks but 1 in 12 weekends. The on-call rota allocates the Specialist Trainee to a variety of specific roles on AMU and/or referrals from A&E and medical emergencies throughout the hospital.

The Specialist Trainee will be integrated with the present Specialist Trainee in Clinical Pharmacology post to establish a rotating training programme for two trainees with training programmes designed to meet the particular needs of the individuals.

b) Clinical Pharmacology & Therapeutics Programme

The trainee is expected to undertake research both within the Pharmacology and Therapeutics Group within the Department of Cardiovascular Sciences, and also with the Industry partner (Roche or Astra-Zeneca). The research programme will take into account the interests of the trainee. Trainees will be encouraged to work towards a higher degree such as an MD/PhD. Training will be provided in research methodology, including statistical methods for data analysis. There is a formal course for new MD applicants, which incorporates elements such as statistics, laboratory work and animal husbandry. If desired, the Specialist Trainee could apply for external fellowship funding for out-of-programme experience, perhaps using preliminary research data obtained during this period of training. A variety of clinical pharmacology projects will be available e.g. drug/ligand action in cell models to human subjects, monitoring of therapeutic response etc.

The Specialist Trainee is expected to report his/her research findings at national and international meetings. Active participation in the British Pharmacological Society is encouraged.

The teaching commitments are detailed below. In addition, participation in the University Hospitals of Leicester Therapeutics Advisory Group, the Leicestershire Drug Information Service and as an observer in the local Research Ethics committee will be encouraged.

The Pharmacology and Therapeutics group is very active in participating in Phase III clinical trials, predominantly in the field of cardiovascular disease. The Specialist Trainee is expected to gain experience in the running of these trials and assist in the recruitment, assessment and monitoring of patients in these trials.

A timetable for the Specialist Trainee post (whilst in CPT training) is given below as an example.

	AM	PM
Monday	Heart Failure Clinic/Cardiology clinic	Research
Tuesday	Research/Clinical Trial work	Research
Wednesday	Research/Clinical Trial work	Post infarction and Secondary Prevention Clinic OR general medical clinic
Thursday	Research	Research or Pharmacology Course teaching
Friday	Research	Undergraduate Bedside Teaching, Academic half day teaching

Experience of CPT within industry

Certain elements of the CPT training programme cannot be attained at the University Hospitals of Leicester. These parts of the training may therefore involve rotation to an industrial partner (eg. Roche Pharma or Astra Zeneca). The Specialist Trainee could spend between 6 months and 1 year at an industrial placement for this part of CPT training.

Roche and Astra Zeneca are innovative pharmaceutical companies dedicated to the discovery, development and marketing of new medicines for the treatment of unmet medical needs. The primary research and development base for Roche in the UK is based at Welwyn Garden City and for Astra Zeneca at Loughborough.

Clinical Pharmacology contributes to the discovery, development, registration and marketing of new medicines by:

1. Advising research on compound selection.

2. Executing the exploratory clinical pharmacology programme (Phase I and IIa).

3. Executing the clinical pharmacology components of the Full Development Registration trials.

4. Supporting the marketed drugs and answering Regulatory questions (pharmacovigilance).

The particular expertise of pharmaceutical industry, however, is concentrated in the exploratory or early clinical development phases where they:

1. Assess the suitability of the toxicological and pre-clinical drug metabolism data for selection of potential compounds and their respective doses for man.

2. Design, execute, report and interpret the Phase I and IIa programme in order to select the dose range for IIb and III.

3. Determine the dynamic, kinetic and safety of the potential drug, which will enable the Registration trials to commence.

The principles underlying this training with an industrial partner are as follows:

a) The programme will be tailored to match the individual's experience and expectations, but ensuring the core skills are taught.

b) A senior director will be appointed as supervisor.

c) A physician or scientist will ‘partner’ the applicant during the course.

d) The training will be a mix of applied practical experience, tutorials and workshops, external and internal courses, and attendance at selected scientific meetings.

e) Course reading material will be recommended; access to the library and electronic facilities e.g. Medline are available.

f) A project related dissertation of approximately 10,000 words could be written or the incumbent could study for an MD related to joint research initiatives with the Pharmacology and Therapeutics Group in Leicester.

g) Active participation in some of the following is strongly recommended.

i. Conducting a phase I and II studies.

ii. Management of a therapeutic-related project.

iii. Developing a pharmacodynamic model.

iv. Conducting basic pharmacokinetic analyses.

v. Conducting elementary statistical analyses.

vi. Working in an analytical laboratory for measurement of drug concentrations.

vii. Working in a toxicological laboratory to actively assist in toxicological testing.

viii. Drug licensing

ix. Pharmacovigilance and monitoring

Teaching

Medical education is an important component of the training of CPT specialists, and should include undergraduate teaching of the basic principles of clinical pharmacology in order to promote the safe prescribing of drugs. The Specialist Trainee would be expected to contribute to teaching appropriate to their expertise on the MB ChB and other undergraduate & postgraduate courses. The medical curricula are integrated, and the structure and content is the responsibility of a single Medical School Curriculum Committee. They are coordinated by the Department of Medical & Social Care Education in consultation with academic departments. Staff may contribute to lectures, tutorials or practical work in either the core curricula or student selected Special Study Modules. In the case of the core curricula, staff will be responsible to a relevant Module Leader, who may not necessarily be based in the member of staff’s own department, for the content and nature of their teaching.

In addition department staff participate in the training of postgraduates at the Leicester Royal Infirmary. The Specialist Trainee will be expected to participate in these teaching activities, including lectures on clinical pharmacology topics.

The following comprises some of the regular commitments for this post:-

· Undergraduate teaching clinical pharmacology, including lectures in Phase I “Mechanisms of Clinical Pharmacology Module”

· Undergraduate ward teaching – clinical methods, diagnosis and therapeutics

· Undergraduate teaching case discussions in the 5^th year Academic Half Days

· Undergraduate teaching - cardiovascular/urinary tract modules

· Undergraduate teaching – special study module “From molecules to man”, run in conjunction with AstraZeneca Charnwood.

· Undergraduate assessments, including grading short answer papers in clinical pharmacology or other modules

Research

The major research interests of the Department/Group (for which we have an international reputation) are orientated around the application of scientific techniques to the investigation of the pathophysiology and therapeutics of cardiovascular disease with particular emphasis on ischaemic heart disease, hypertension, heart failure and vascular disease. The University has an outstanding record in Biological Sciences, which offers excellent opportunities for interdisciplinary research. Our group has interests in both basic and clinical research.

In addition to the above research opportunities there is also a unique ability to collaborate with the scientists in a wide range of laboratory disciplines in the University/MRC Centre for Mechanisms of Human Toxicity. Associated with the Centre and the main University campus are several 1 year MSc courses in subjects of particular relevance to Clinical Pharmacology e.g Molecular Pathology and Toxicology and Medical Statistics and Information Technology.

The Specialist Trainee will be encouraged to participate in research that will lead to a higher degree such as the MD or PhD, depending on the preferences of the post-holder. He/she will be encouraged to report and publish their findings in national/international meetings/journals, and there may be opportunities to write grant/fellowship applications.

The Pharmacology and Therapeutics Group (within the Department of Cardiovascular Sciences, University of Leicester) - Head: Prof. L. L. Ng

Cardiovascular research has been a major strength of the Leicester Medical School since its inception. Its sustained excellence has been recognised by being specifically flagged in all the Research Assessment Exercises and in the 2001 RAE, cardiovascular research at Leicester received a 5 rating. The formation of the new Department of Cardiovascular Science as a recognition of this strength will provide additional focus and value and further strengthening of this research area is a strategic objective of the Medical School.

The Department of Cardiovascular Sciences (Head, Prof. Nilesh Samani) is one of the largest Departments in the University with currently over 150 staff members. The Department currently occupies accommodation in the Robert Kilpatrick Clinical Sciences Building at the Leicester Royal Infirmary, the Clinical Sciences Wing of Glenfield Hospital and on the University campus. There are advanced plans to construct a new state-of-the-art Cardiovascular Research Centre at Glenfield Hospital. The new Centre will enable physical co-location of the various groups carrying out cardiovascular research in Leicester and allow greater integration of their activities, with consequent benefits in terms of collaboration, productivity and excellence. The location of the Cardiovascular Research Centre at Glenfield Hospital, the main hospital providing secondary and tertiary cardiology care in Leicester, will provided the optimum setting for interactions between clinical and basic researchers and allow the best opportunity for undertaking translational research.

The research of the Pharmacology and Therapeutics group involves both clinical and basic pharmacology. The clinical research interests of the group include the use of biomarkers such as the natriuretic peptides for diagnosing, and predicting the prognosis of, heart failure and ischemic heart disease. Systems biology research and bioinformatics are utilised for development of diagnostic and prognostic tools. The group has participated in many large-scale clinical trials on cardiovascular drug therapy in both heart failure and post-myocardial infarction, and there is a large database of coronary admissions enabling research on pharmacoepidemiology or pharmacoeconomics, audit and long term studies on the trends in heart disease and effects of treatments. Other clinical studies involve the role of specialist nurses in heart failure care.

Basic science studies include the role of sodium hydrogen exchangers in hypertension, diabetic nephropathy and pre-eclampsia; the role of the NADPH oxidase derived free radicals in tissue damage in hypertension, diabetes and pre-eclampsia and studies on phosphorylation dependent events in activation of membrane exchangers and free radical producing pathways.

Administration

The Specialist Trainee participates in the following administrative activities, which comprises the curriculum for trainees in Clinical Pharmacology & Therapeutics: -

1. Member of Leicester Royal Infirmary Therapeutics Advisory Group.

2. Adviser to Trent Drug Information Services (new product evaluation).

3. Member of District Drug Formulary Committee.

Informal Enquiries

Informal enquiries are welcome and may be made to Prof. Leong L. Ng, Pharmacology & Therapeutics Group, Cardiovascular Sciences, Leicester Royal Infirmary (Tel: 0116 2523126 or email lln1@le.ac.uk).

Shortlisted candidates are invited to visit the departments concerned by contacting the Secretary to the following :-

Professor Leong L. Ng or Professor D B Barnett,

Pharmacology & Therapeutics Group,

Dept. of Cardiovascular Sciences,

University of Leicester Medical School

Robert Kilpatrick Clinical Sciences Building

Leicester Royal Infirmary

Leicester LE2 7LX

Tel: direct line (0116) 252 3126