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Clinical Trials Pharmacy

We have an experienced team of pharmacists and technicians providing expert pharmaceutical knowledge and advice to ensure the safe and effective administration of treatment to our clinical trial patients.

Specialist roles include:

  • Providing pharmaceutical advice for the design of trials sponsored by CCC
  • Advice on the administration and side effects of novel clinical trial agents
  • Dispensing, accountability and storage of all clinical trial agents
  • Designing individual and bespoke procedures and prescriptions for each trial
  • Ensuring compliance with necessary national and international clinical trial legislation and regulation
  • Liaising with all members of the research team to ensure seamless delivery of clinical trials to patients

Our purpose built licensed pharmacy aseptic facilities contain a number of class 1 isolators and a dedicated gene therapy suite which allows us to provide novel biologic, chemical and gene therapy agents as part of clinical trials. These facilities have a continuous environmental management system, which assures the quality of the agents we produce.

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Research Radiology

Diagnostic Imaging provides multimodality imaging applications to effectively manage and treat oncology patients.

Imaging modalities available for research include Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography combined with Computed Tomography (PET/CT), Nuclear Medicine, Ultrasound and X-ray procedures.

We have a large portfolio of active clinical trials evaluating new treatments and therapies. Diagnostic Imaging plays an important role in Clinical trials with the use of novel radioactive treatments and in the assessment of solid tumour response to trial treatments.Clinical Trial protocols often require complex imaging to be performed more frequently than routine care.Scans are performed by experienced diagnostic radiographers to comply with the assessment requirements of the Clinical Trial protocol and radiologists provide a comprehensive radiological report.

Scan results assess treatment efficacy using radiological tumour assessment criteria, such as RECIST (Response Evaluation In Solid Tumours); In CCC Imaging this assessment report is completed by Diagnostic Research Radiographers and has provided vital support to research investigators.

We act as both a participating trial site or the main UK investigating site. Diagnostic Imaging currently has a Radiologist as Principal Investigator for MRI in Ovarian Cancer (MROC )Trial and provides imaging support for a number of University-led research projects with both Liverpool and John Moores Universities.

Magnetic Resonance Safety Experts (MRSE) deliver both practical development work and safety advice on all aspects of MRI research studies. Diagnostic Imaging also provides Clinical Radiation Experts (CRE) and a Medical Physics Expert (MPE). These experts assess research ionising radiation exposures for compliance with research Ionising Radiations Regulations (IR(ME)R ), give advice to research investigators regarding research imaging assessments and provide radiation risk assessments for CCC Clinician-led submissions to research ethics committees.The Diagnostic Imaging MPE also provides advice regarding ionising radiation in medical applications and the requirement for Research ARSAC (Administration of Radioactive Substances Advisory Committee) certificates when radioactive substances are required to be used in a trial.

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Research Radiotherapy

Radiotherapy treatment involves precise pre-treatment processes. Ranging from pre-treatment imaging, formulation of radiotherapy treatment plans, pre-treatment quality assurance and pre-treatment checks. While receiving radiotherapy patients’ receive care by radiographers.

If patients are on a trial their treatment follows all the same processes. Intricate details of trial patients’ radiotherapy are different to the standard of care.

The radiotherapy department has two dedicated radiographers that oversee all the different clinical trials that are currently open and facilitate new trials that the doctors want to open. It is their responsibility to ensure effective and seamless communication throughout all aspects of Radiotherapy and the multi-disciplinary teams.

Research and Development Expert Practitioner-Louise Turtle

Louise is responsible for facilitating and participating in research & development within radiotherapy. This involves the set up of research studies, collaborative working within the multidisciplinary team from start to completion of study and the sharing of results via medical journals or presentations.

Clinical trials Research Radiographer-Michelle Forshaw

Michelle is the clinical trials main point of contact for radiotherapy.She oversees all clinical trials activity from feasibility of trials to patients’ completion of radiotherapy treatment. She works closely with other members of the multidisciplinary team to ensure the smooth running and organisation of radiotherapy clinical trials.

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Academic Nurse Researcher

The role of academic nurse researcher incorporates a range of work streams:

  • Supporting research capacity and capability amongst nursing, and allied health professionals (Cancer Rehabilitation and Support Team)
  • Promoting and supporting patient and public involvement in research
  • Working collaboratively with external organisations and partners to develop research proposals and funding applications
  • Take forward research studies which are identified as priority areas for patients, the organisation and the broader NHS

The role involves partnership working with a broad range of research partners both regionally and nationally, for example:academic staff; healthcare professionals; patients, families and the public; research networks; and charities. An example of a recent research study termed ‘PACT’ — Peer support to maintain psychological wellbeing in people with cancer: A feasibility study for a Randomised Controlled Trial, involved staff from Universities of Manchester, Lancaster, Liverpool and Southampton, The Clatterbridge Cancer Centre NHS Foundation Trust, The Christie NHS Foundation Trust, and patient representatives.

It is important that health services research is informed and guided by patients, families and the public to identify research that is important and relevant, to ensure that the right questions are asked and to help make sure good research is heard about and reported in ways that are meaningful to people. Patients, families and the public may hold a variety of roles as research partners, for example, advising on study documents; reviewing and commenting on research proposals; identifying priority areas for research and assisting with knowledge sharing from study findings. Training and support is made available to enable patients, families and the public to actively engage in their role/s with knowledge, skills and confidence as required. Resources from NIHR INVOLVE 1 support this activity.

Nurses and allied health professionals are encouraged to apply for local/regional or national funding opportunities. Examples include the NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRCs) programme 2; The Health Education England (HEE) and National Institute for Health Research (NIHR) Integrated Clinical Academic (ICA) Programme 3; and The Health Foundation grant programmes 4. Involvement in research is also enabled through secondment opportunities and specific research roles such as co-applicant or advisor to a project. Staff are supported to present and publish the results of their research.

The role incorporates the mentoring and supervision of students who are undertaking postgraduate study at Masters and PhD level. This requires working with the relevant CCC departments to ensure the approval and set-up of the study, as well as signposting students to relevant information and support. Access to services such as the Research Design Service 5 and NHS North West Leadership Academy (NHS NWLA) 6 provide individuals with additional expert advice.

References

1 http://www.invo.org.uk/about-involve/ [accessed 24/09/2018]

2 NIHR (2018) NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRCs),

https://www.nihr.ac.uk/about-us/how-we-are-managed... [accessed 24/09/2018]

3 NIHR (2018) ICA HEE/NIHR Integrated Clinical Academic Programme for non-medical healthcare professions,https://www.nihr.ac.uk/funding-and-support/funding... [accessed 24/09/2018]

4 The Health Foundation (2018) Funding and fellowship opportunities, https://www.health.org.uk/funding-and-fellowship-o... [accessed 24/09/2018]

5 NIHR (2018) Research Design Service (RDS), https://www.nihr.ac.uk/about-us/how-we-are-managed... [accessed 24/09/2018]

6 Northwest Leadership Academy (2018) https://www.nwacademy.nhs.uk/ [accessed 24/09/2018]