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Clinical Research Fellows

As a clinical research fellow at the Early Phase Clinical Trial Unit (EPCTU), we get exposure to cutting edge research at Oxford.  We are testing novel translational drugs in first human subjects ranging from immunotherapy, targeted therapy and in combination with conventional chemotherapy and radiotherapy on a wide range of cancers.  As safety is paramount in the early phase setting, we have to be extremely vigilant and monitor these patients closely for any adverse events that can potentially be related to the experimental treatment, ensuring that the Principal Investigator (PI) and sponsor of the trial are aware of these events.  In addition, we are given full responsibilities in overlooking a number of trials and attending regular safety review committee meetings to further as assess dose limiting toxicities (DLT) and maximum tolerated dose (MTD).

Day to day responsibilities involve recruiting and consenting eligible patients for trials.  In addition, we review patients currently on trials and manage all complications including those caused by the experimental drug and those arising from disease progression.  We work closely with research nurses, pharmacist and sampling handing lab team to provide patients with a seamless experience during their time at the EPCTU.  We also get opportunities to work on a number of research projects under supervision of the PI and can present these findings in
conferences, both locally and abroad.  Working in the EPCTU at Oxford is a truly a unique experience and I strongly encourage anyone pursuing a career in Oncology to consider applying.

Consultants

Professor Mark Middleton

Professor of Experimental Cancer Medicine
Consultant Medical Oncologist, Oxford Cancer and Haematology Centre


Dr Sarah Blagden

Associate Professor of Experimental Cancer Therapeutics


Dr Simon Lord

Consultant Medical Oncologist, Oxford University Hospitals NHS Foundation Trust


Dr Graham Collins

Haematology Consultant

Data Managers

The EPCTU team consists of 6 data managers.  Our objective is to collate all the trial information from patient notes onto the Case Report Form (CRF) as soon as possible.  We set a timeframe of 3-5 days from the patient visit to get data entered onto the CRF.

We focus on around 50 active recruiting trials (oncology and haematology) ranging from a variety of different cancer types and we also have around 30-40 follow up trials which have stopped recruitment.  Within these follow-up trials, we follow up information about patients’ status in relation to the trial which is also captured on the eCRF.

The trials are mostly commercial research but we do support academic trials too.  The trials we support vary between phase one to three.

Most information is accessed from the patient notes and Electronic Patient Record (EPR) but we also liaise with the Principal Investigators, Doctors and Nurses where data queries arise.

Nursing Team

We are a team of 4 research staff nurses, led by a senior nurse.  Our nursing team’s focus is to deliver high quality patient centred care.  We are the patients’ first point of contact on the unit; we strive to make them feel comfortable and confident during their visits.  We take pride in the therapeutic relationships we develop with our patients and their family and friends.

Clinically our role includes patient assessment, patient monitoring, phlebotomy, cannulation, drug administration (including delivering systemic anti-cancer therapies), wound care, collecting and processing blood samples in our on-site laboratory and providing a triage service for unwell cancer patient.  The research staff nurse is a developmental role, where we are becoming experts in oncology, haematology and clinical research.  We are the patients’ advocates; we put the person at the centre of clinical research.

Research Nurses

We are a team of 9 specialist nurses working with oncology and haematology patients within early phase clinical research.  Our nursing team’s focus is on delivering high quality patient centred care within a dynamic dedicated trials unit.  We aim to ensure each patients needs are met, including those specific to their disease type and trial demands, as well as assessing and delivering their holistic needs during their time with us.

As individual nurses, we have our own portfolio of approximately 8 trials and caseload of patients.  Each nurse becomes the expert for their particular trials and the specialist nurse for their patient.  Taking a leap of faith with our patients that this will be the next cancer cure is exhilarating.  We have expertise in drug administration, including intra tumoural injections, immunotherapy and personalised medicine.  A key component of our role is communication - explaining the trial and what it involves, planning and booking study visits and investigations, triaging our patients, linking with other healthcare professionals including palliative care, primary care and allied health care professionals.

In addition to our clinical role, we interact with the study sponsors and trials offices, helping with data and ensuring the study visits match the protocols.  Overall, we work autonomously within a team, getting a fantastic balance between hands on patient care and contributing to scientific discovery – creating tomorrows experts today.

Sample Handling Lab

The Sample Handling Lab (SHL) is based on the Early Phase Clinical Trials Unit (EPCTU), the laboratory is staffed by a team of 6 technicians.  The lab is responsible for the pre-analytical (first stage) processing of samples collected from patients participating in oncology and haematology studies.  Due to the location of the laboratory and the proximity to the patients, it is possible to process samples within 15-30 minutes of collection.

The SHL is a separate laboratory to the hospital’s ‘local’ lab where patient’s samples are analysed for safety/diagnostics, in comparison the role of the SHL is purely research.  As the lab handles samples for research, patient samples are anonymised and labelled with the patient’s unique trial identification number.

The SHL predominately separates blood into its different components (plasma, white cells and red cells) before sending the required part to the analysis lab which has been chosen by the study.  The lab handles a variety of sample types such as blood, urine, nail clippings and tissue samples.  The SHL sends samples globally on a daily basis via courier.

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Trial Administration

The Early Phase Hub consists of a team of trial administrators dedicated to facilitating the opening and ongoing regulatory conduct of trials being run through the Early Phase Clinical Trials Unit, Late phase Oncology Team and Late Phase Haematology Team.

The trial administrators are responsible for all non-clinical regulatory aspects of the trials, throughout their lifetime.  All Oxford site set up activities are coordinated via the hub as a single point of contact.  The hub approaches and engages all the necessary support departments (pharmacy, radiology, path labs etc) required by the protocol and liaises with R&D for confirmation of capability and capacity and arrange the site initiation visit.  We endeavour to achieve site initiation 60 days from acceptance into our pipeline and receipt of a full regulatory document set.