William Harvey Clinical Research Centre

The Clinical Research Centre (CRC) was established in 1997 and moved to the newly built William Harvey Heart Centre (part of the William Harvey Research Institute, Barts and The London School of Medicine and Dentistry) in 2011. The Centre is part of the National Institute for Health Research (NIHR) Cardiovascular Biomedical Research Unit and part of the world leading cardiovascular research programme at the new Barts Heart Centre, which is now the largest tertiary heart hospital in the UK. 

Initially, the centre focused on blood pressure and cholesterol studies (such as ASCOT, Pathway and ILLUMINATE). The centre has widened its portfolio to include diabetes/renal, endocrine, respiratory and cognitive decline studies. The centre runs all types of studies ranging from niche complex studies on rare diseases to large scale trials and health service interventions.

The CRC runs clinical trials (Phase II to IV) in multiple therapeutic areas. As well as clinical trials of investigational medicinal products (CTIMPs) the centre also runs device trials and other observational studies. We have a broad portfolio of studies and involve Principal Investigators from Barts Health Trust as well as from Queen Mary University of London (QMUL).

We are involved in a number of patient and public engagement activities and actively work with GP practices serving 500,000 people in East London. 

Vision

Our vision is to be a world-class clinical research centre conducting globally influential trials that make a positive impact on patient care locally.  

We aim to: 

  • Build on our international, reputation in translational and clinical research
  • Play a key role in the cardiovascular research programme at the new Barts Heart Centre
  • Offer patients a large portfolio of clinical trials that they can participate in
  • Promote the public understanding of clinical trials.

Values

Our values are central to how we work to achieve our aims. We work in a way that is:

  • Focused on safety and quality of patient care
  • Conducive to building ongoing relationships with local GP practices and Principal Investigators within Barts Trust
  • In line with Good Clinical Practice and provision of a quality service.

Mission

Our strategic goals are to: 

  1. Increase patient participation in clinical trials
  2. Diversify our portfolio of studies
  3. Ensure the conduct of our trials is to the highest quality standards
  4. Deliver our studies to time and target.

Links to Barts Health Trust and Quintiles

The Centre is situated in central London on the QMUL campus of the Barts School of Medicine and we have strong links with Barts Health Trust. The Barts Health Trust is the largest in the UK and the new Barts Heart Centre is the largest tertiary heart hospital in the UK. Cardiovascular research will expand with the coming together of the research groups from the London Chest Hospital and the UCL Heart Hospital. 

The University College London Partners (UCLP) Quintiles Prime Site based here, has now expanded across UCLP. It is the world’s largest Prime Site. The Prime Site concentrates clinical trials across multiple therapeutic areas in a single hub and last year was one of the top recruiters worldwide. London is the most active research area within England and we have access to a large and ethnically diverse patient population in inner London. 

Achievements

  • The first UK renal denervations were done here in 2008 and the first twin-artery denervations in the world. These studies have resulted in two Lancet publications
  • ASCOT, now with a long-term follow-up study ASCOT-10, has been one of the most influential trials in cardiovascular prevention, with over 100 papers and atorvastatin has become the biggest selling medication in the world
  • Hi-Lo with over 9,000 patients has been the highest accruing study on the NIHR portfolio for several years. After the Hi-Lo intervention Tower Hamlets went from worst to best for control of blood pressure and cholesterol control
  • The CRC is often one of the highest recruiters globally on the studies on our portfolio.

Where are we? Current status

Currently, the Centre has circa forty clinical trials with about thirty open to recruitment.

Approximate breakdown of trials by type:

  • Cardiovascular (55%), diabetes and endocrinology (10%), respiratory (25%), mental health and neurology (10%).

Patient Studies

Studies currently recruiting:

TIME study

The big question is, would taking blood pressure medication in the evening be better (or worse) than taking it in the morning in preventing strokes and heart attacks? The TIME study will try to answer this question

SPIRE study

We are currently recruiting  patients with high cholesterol and a history of heart disease, kidney disease or diabetes for a study of an investigational medication. Find out more about the SPIRE Study.

The Strength Trial – Help us to find a way to protect your heart

Do you take statins? Do you have a history of heart attack or stroke? Are you at high risk of heart attack or stroke?

We are currently recruiting patients for a clinical research study looking at a concentrate of omega-3 fatty acids to see whether it can help to decrease the risk of serious heart problems in people diagnosed as having a high risk of heart disease.

Watch our videos to learn more about what's involved and how you can participate. 

WAVE iV study

Join our trial of “life changing” one-hour treatment to lower blood pressure. Local people suffering from uncontrolled high blood pressure are being invited to take up an exciting new treatment using ultrasound-based energy, being trialled for the first time in London at St Bartholomew’s Hospital this summer.

The one-hour treatment is an exciting and innovative opportunity for the estimated 4% [1] of adults in London living with resistant hypertension - a severe form of high blood pressure that cannot be controlled with drug therapy, putting them at constant risk of suffering a stroke or severe heart problems.

The treatment is the subject of a randomised clinical trial known as WAVE IV. In previous trials of the therapy, three-quarters of treated patients experienced a meaningful reduction in their blood pressure following the one-time, one-hour therapy.

Now, people in east London are being given the chance to sign up to the randomised trial being run by Queen Mary University of London and Barts Health NHS Trust.

Patients may be eligible to participate in the WAVE IV clinical study if:

•    They are aged between 18 years of age and 90 years of age.
•    Their systolic blood pressure (top number) is greater than 160 mmHg.
•    They are currently taking three or more prescription medications for high blood pressure.

People who wish to find out more and assess their suitability for the trial can contact Anne Zak at the William Harvey Heart Centre Clinical Trials Unit on 0207 882 5657.

CARMELINA study

The CARMELINA Study is a Phase 4 clinical trial. The purpose of the CARMELINA Study is to look at the impact of linagliptin on the long-term occurrence of selected complications of cardiovascular disease (e.g. stroke or heart attack), as compared to placebo, in people with type 2 diabetes mellitus receiving standard of care. Find out more about the CARMELINA study.

Credence study

The Credence study is looking at an investigational medication versus placebo to see if it can slow down the progression of kidney disease in patients with Type 2 Diabetes. Find out more about the CREDENCE study.

Odyssey study

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome. Find out more about the Odyssey study.

Optimize study

We are currently recruiting patients for a clinical research study looking at an investigational medication for people with severe COPD that is already approved at a particular dose in more than 60 countries. This study looks at how effective the investigational medication is when it is taken at different doses. The study medication is a tablet taken once a day in addition to your existing COPD treatments. For further details click. Find out more about the Optimize study.

Tommorrow study (CLOSED)

The Tommorrow study is researching a new investigational test to see if it can help identify individuals who are at higher risk of developing memory problems due to Alzheimer’s disease in the next 5 years, and testing a new investigational treatment to see if it can delay the memory problems due to Alzheimer’s disease. This research study is currently recruiting healthy older participants. Find out more about being part of this new research effort. Find out more about the Tommorrow study.

Fourier study (CLOSED)

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease. Find out more about the Fourier study.

 

Results & Publications from studies

September 2015
The Summit COPD CV Survival Study

Healthy Volunteers

Are you fit and healthy? 

Aged 18-45?

Non-Smoker?

On no medications (except the contraceptive pill)?

Your time and travel expenses will be compensated.

We currently have three trials that require healthy volunteers:

To express interest or to receive further information, please contact: Sister Amy Robertson

Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Tel: 020 7882 8931

 

Patients' Groups

Why we’ve got an Interested patients group

  • Healthcare policy is based on results from big trials.
  • But few people take part 
  • Your experience could help to guide us on how to explain to others what it is like to take part (this is a national question too). UK Healthcare policy is trying to work out how to assess good care.
  • This is extremely difficult to pin down.
  • We know how big the benefits are from reducing BP and cholesterol. But helping GP’s and nurses to do this in everyday practice is difficult.
  • Your group has shown how well it can take medication and improve it’s BP and cholesterol. Could your experiences help the outside experts understand how and why you did so well and see if we could produce ideas or methods that could pass on this benefit to others?
  • The clinical research team are involved in many different areas of research. They would value your ideas about new studies which might be done here, or in our GP surgeries or ideas or questions that might lead to new studies, from you.

So far, patients have got involved with:

  • Focus groups with the National Institute for Health Research Recruitment Research Methods Group
  • Making videos for: Tower Hamlets Primary Care Trust
  • Interviews for the DIPEX project on clinical trials
  • Making video material for patient recruitment
  • Stills photography (Colin O’Brien) for the above
  • Paul Bowers-Issacson produced part of a new AS level curriculum on Science in Society which features Clinical Trials
  • John Greenwood got so carried away with communicating patient experience he set up his own company.

If you want to be involved register with us and we’ll send you regular updates on what we’re doing. It’s all voluntary and we’ve been having fun so far!

Frequently Asked Questions

Frequently Asked Questions and Answers

What do the different phases of clinical trials mean?


Phase I studies

Phase I clinical trial researchers are often testing a treatment which may be in the earliest stages of development in a small group of healthy people (i.e. usually 10 to 30 volunteers). The information gathered from such trials will provide the manufacturers with important data on how the medicine is tolerated, how the body absorbs, breaks down and eliminates the drug and whether any side effects have been experienced by those taking part in the trial. The initial doses of the drug used in Phase I studies are very small and are only increased during the study if no significant side effects or intolerance is seen. We rarely do Phase 1 trials.

Phase II studies

Once a new medicine has successfully passed the Phase I study stage, the drug will be administered to a larger number of people (i.e. usually 100 to 200 patients). In these trials the drug will be tested on those who are actually suffering from the condition the medicine is intended to treat. The objective of Phase II studies is to help the manufacturer of the medicine to identify a drug with a genuine therapeutic potential (it will actually help to treat the condition being targeted).

Phase III studies

Phase III trials are an important turning point for the manufacturers of the new medicine. The purpose of phase III trials is to gather even more information about the effectiveness and safety of the new medicine from large numbers of patients (several hundred to several thousand patients). It will improve the medicine’s effectiveness with standard treatments. Phase III studies generally run from two to four years and are likely to be carried out in many different centres – and often different countries.

Phase IV studies

Phase IV trials are carried out when the medicine has become available on the market for prescription or is available over the counter. Information gathered provides the regulatory authorities and the pharmaceutical company with valuable information on the drug’s properties when administered to different groups of the population. Also of any side effects that may become apparent with continued use.

By participating in a Phase I (healthy volunteer) study, it is not anticipated that you will receive any therapeutic (treatment) benefit from taking part. It is therefore considered ethical and appropriate that you should be paid for your time and inconvenience. The amount of payment you receive for each trial will vary and is calculated on the amount of time that you have to devote to the study, the number of visits and also the inconvenience anticipated based on the planned procedures. An Independent Research Ethics Committee will have approved all payments to volunteers for trial participation.

How safe is it?

Clinical trials are carried out under the strict supervision of fully qualified doctors, nurses and other health professionals. All trials are run in accordance with European legislation and two government bodies must first approve all trials before any clinical procedures may commence. These are the MHRA (Medicines and Healthcare Products Regulatory Agency) and a government authorised REC (Research Ethics Committee). In order to give approval for the study to go ahead the MHRA experts will assess all applications for new medicines to ensure that they meet the required standards. Members of a REC will often include patients, members of the public, nurses, GPs, hospital doctors, statisticians, pharmacists and academics, as well as people with specific ethical expertise gained through a legal, philosophical or theological background.

Before every trial volunteers are given a full pack of information about the study to read through in detail and are able to spend as much time as required with one of the Research Doctors discussing all the details and potential risks of the study. This process is called informed consent and will be completed before any study procedures are able to take place. After the formal consenting session with the doctor you will be able to take the information home to discuss with friends, family and your GP. A consent form should not be signed until the participant feels that they have enough information to make the decision to take part, and even once the form is signed volunteers are able to withdraw their consent from a study at any time.

Before any volunteer can take part in a clinical trial, we take great care to ensure that you are suitable to do so. Volunteers are very carefully screened against the approved study protocol and are required to undergo a thorough medical examination, which includes taking blood samples for a variety of tests as well as tracing your heart (ECG) and measuring your blood pressure. We will also contact your GP to check that there are no medical conditions in your history that might affect your participation. Only those volunteers meeting the strict criteria set will be selected for participation and included in the study. They are very closely monitored throughout for any potential side effects.

What happens first?

If you want to be considered you will be information about the trial and given as much time as you need to read through it. Next you would make an appointment to come to the Unit and you will be asked to bring Identification with you and your GP contact details. A doctor will take you through the background and purpose of the study giving you a chance to ask any questions you like. Once you feel you have enough information to decide to take part the screening medical will commence. The screening visit will usually include having your heart traced (ECG), your blood pressure measured, and the screening blood samples taken. You will have urine tests which will include a drug screen. During the screening a doctor will conduct a medical examination and you will be asked about your medical history and any medication that you may have used.

With your permission, we will contact your GP surgery to check that there is no history of a medical condition, which may affect your participation in the study. We will ask your GP to confirm any medication that you have used.

What sort of medicines do you test?

We conduct trials in a wide range of medical conditions. Some of the medicines are newly discovered and may eventually lead to breakthroughs in disease management and patient care. Other trials involve medicines that have been marketed for many years, but the manufacturer may want to develop an improved formulation or a try out a new delivery system. Some of the areas where we have conducted trials include:

  • Cardiovascular disease (problems with the heart or circulation)
  • Respiratory disease (diseases of the lungs – such as asthma)
  • Disorders of the central nervous system (such as epilepsy, depression) & treatments for pain
  • Metabolic disorders (including conditions such as diabetes)

How often can I take part in trials?

For your health and safety it is important that you do not take part in trials too often and especially not simultaneously i.e. enrol to take part in studies with us and at other centres. If you have taken part in a clinical trial and you are unsure about when you can next safely participate in another one, we would be happy to discuss this with you.

How long do the trials last?

Mostly studies are ‘out-patient’ based which means that you would have to attend for several visits to the unit for monitoring during the trial. Occasionally a trial may be required to be resident in the unit.

Contacting your doctor

Part of our study recruitment processes involve contacting your family doctor, with your permission. This is to ensure that all volunteers who take part in a study are eligible to do so.

How will my data be handled?

Queen Mary, University of London and Barts and the London School of Medicine and Dentistry are registered under the Data Protection Act 1998. We have a responsibility to ensure that we comply with the principles of data protection. With your consent, we will store information about you on our secure volunteer database, which is only accessible by relevant members of staff. If you choose to participate in a study then you will be asked to give your consent for your information to be shared with relevant personnel from the company sponsoring the trial and their representatives. Volunteer records may also be disclosed to regulatory authorities for medicines in the UK and elsewhere. Our volunteers are entitled to access information held about them if they so wish.

Register With Us

Register with us

Register with us to be contacted about the latest clinical trials relevant to you and your condition. Your details will be entered onto our Barts & The London part of a proven and secure commercial system called iGuard.

You will be sent information about new clinical trials (you would, of course be under no obligation to take part). You may be sent questionnaires from doctors and commercial companies who want to develop new ways of treating your condition. You don’t have to complete any of these if you don’t want to.

You can limit the range of information you receive to our studies at Barts and The London, alternatively you can receive information from all over the world. If you opt for global trials then you get information from international researchers. Click on an option below:

  1. Register with all worldwide researchers interested in my condition (all partners working with the iGuard team).
  2. Register with the William Harvey Research Institute Clinical Research Centre (ASCOT Clinic) at Barts & The London and our partners.

If at any time you want to cancel or change to the other option then you can change this within the iGuard site.

Signing up will give you access to the drug safety alerts which are part of the iGuard system (so you would be alerted to potential problems with adding new medicines to your regime, or if there were new worries with any of the drugs which you are taking).
MediGuard 

The Patient Experience

The Patient Experience

 

Key People

Our Team

The team at the Centre is made up of clinicians, research nurses and clinical scientists. We have our own dispensary and lab for the preparation of samples. We also have specialists in feasibility and start-up and in quality management.

Professor Mark Caulfield - Institute Director / Centre Lead

Dr David Collier - Senior Research Fellow, Head of Team
T: 020 7882 5649
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Dr Manish Saxena - Clinical Lecturer/Clinical Research Fellow
T: 020 7882 3856
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Dr Julian Shiel - Research Fellow
T: 020 7882 3428
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Dr Vivienne Monk - Clinical Research Centre Manager
T 020 7882 5668
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Anne Zak - Research Nurse Manager
T: 020 7882 5660
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Marian Benford - Quality Manager
T 020 78825673
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Clovel David - Pharmacy/Lab Technician
T 020 7882 5672
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Jane Pheby - Senior Research Nurse
T 020 7882 5664
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Patrizia Ebano - Senior Research Nurse
T 020 7882 5658
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Jo Hadley - Clinical Scientist
T 020 7882 5664
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Carolyn Dawson - Respiratory Research Co-ordinator
T 020 7882 5707
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Wai Yee James - Research Co-ordinator
T 020 7882 5707
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Natasha Aslam - Clinical Trial Practitioner 
Phone: 020 7882 5707
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Rosemary Mullett - Clinical Trial Practitioner 
Phone: 020 7882 5671
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Mital Patel - Clinical Trial Practitioner 
Phone: 020 7882 3499
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Armida Balawon - Clinical Scientist
T 020 7882 5660
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Enamuna Enobakhare - Clinical Scientist
T 020 7882 5712
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Mike Taylor - Administrator
T 020 7882 5662
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Mary Feely - Feasibility Officer
T: 020 7882 6105
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Strategic plan

CRC strategic plan (PDF)

psychometric testing and assessment experience

Clinical Research Centre

The CRC has a number of experienced raters available to work on both commercial and non-commercial studies. We have experience in administering various psychometric scales and raters can perform clinical interviews to determine current levels of functioning. Cognitive and neuropsychological assessments can be performed on research study participants with neurological conditions such as stroke, MS and Parkinson’s Disease, neurodegenerative conditions and dementia, patients with traumatic brain injuries or older adults developing problems with memory loss.

Clinical and Research Psychologists

  • Dr Oda Ackermann DClinPsych – Clinical Neuropsychologist, HCPC Registered
  • Natasha Aslam BSc (Psychology), MSc Health Psychology
  • Sarah Bates BSc (Psychology), MSc
  • Mary Feely BSc (Psychology), MSc Health Psychology
  • Dr Vivienne Monk PhD, C Psychol

Psychometric testing and assessment experience

Certified raters for:

  • Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change-Mild Cognitive Impairment (ADCS-CGIC-MCI)
  • Mini Mental State Examination (MMSE)
  • California Verbal Learning Test -2nd Edition (CVLT II)
  • Brief Visuospatial Memory Test Revised (BVMT-R)
  • Multilingual Naming Test (MINT)
  • Geriatric Depression Scale (GDR)
  • Columbia Suicide Severity Rating Scale (C-SSRS)
  • European Huntington’s Disease Network Registry/Enroll –(EHDN) Motor Rater

Experience in conducting neuropsychological assessments including:

  • Wechsler Adult Intelligence Scale-Forth Edition (WAIS-IV)
  • Wechsler Memory Scale-Forth Edition (WMS-IV)
  • Repeatable Battery for the Assessment of Neuropsychological status (RBANS)
  • Behavioural Assessment of the Dysexecutive Syndrome (BADS)
  • Delis-Kaplan Executive Function System (D-KEFTest of Memory Malingering (TOMM)
  • Birmingham Object Recognition Battery (BORB)
  • All assessments requiring Level 1 Qualification Code

Contact Us

William Harvey Clinical Research
William Harvey Heart Centre
Charterhouse Square
London, EC1M 6BQ
T: 020 7882 5657
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Campus map (PDF)

 

 

 

 

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