The DDU benefits from five full-time Principal Investigators – senior academics and Consultants – with extensive experience in developing, leading and executing Phase I clinical trials. Supporting our investigators is a highly experienced multi-professional team of over 100 staff, who take care of every aspect of the delivery of phase I trials.
Clinical Research Fellows
Clinical research fellows provide comprehensive medical care to trial participants. Our team has 8-10 clinical research fellows at any given time. All our fellows are oncologists in training or have recently completed training equivalent to Specialist Registrars in the NHS. Each trial is allocated a fellow as the Lead Primary Fellow with a backup for each recruiting trial. However, all fellows undertake duties as co-investigators on all trials to ensure cross-cover and scheduling flexibility. We have a long history of these clinical fellows successfully completing postgraduate research degrees including both PhDs and MD (Res.) qualifications.
Clinical Research Nurses
A team of highly skilled oncology nurses with extensive expertise in the conduct of early clinical trials provide 24-hour care to patients on Oak Ward, in accordance with The Royal Marsden care policies and trial protocols. Duties include the administration of investigational medicinal products, sample collection, routine and trial-specific clinical monitoring and its documentation in source records. Led by a matron and two sisters, the team also benefits from three dedicated Clinical Nurse Specialists, a Practice Educator and a Nursing Research Fellow. Whilst comprehensive care is delivered by the entire team, a Lead Nurse is assigned to each trial.
Clinical Study Managers
Each trial is assigned a Study Manager as well as a backup manager, who oversees site level set-up and project management of that trial in accordance with the protocol. The Study Manager is key to communication within the multidisciplinary trial team and is responsible for managing all trial-specific patient appointments and investigations, site-initiation visits (SIV), shipment of kits, equipment or drug, invoicing, and arrangements for external clinical service provision.
Clinical Data Managers
Our team of Data Managers provides comprehensive data processing for our trial portfolio. This includes data extraction from source documents, entry into case report forms (CRF), data cleaning and query resolution, data and essential document quality control, filing and archiving.
Each trial is assigned a Data Manager, as well as a backup Data Manager, who will liaise closely with the sponsor-appointed Clinical Research Associate (CRA) throughout the trial to ensure high quality data are provided within agreed timescales and any data validation queries are efficiently resolved.
Clinical Trial Regulatory Team
Our Start-Up specialist oversees clinical trial set up procedures for each trial including site feasibility assessment, confidentiality and non-disclosure agreements, Research Ethics Committee (REC) and host organisation Research & Development (R&D) submissions, trial costings, advising on content as well as formatting of patient information sheets and consent forms with the input of patient representative committee review. The regulatory coordinator within this team, oversees approvals and dissemination of protocol amendments and other regulatory-related essential documents throughout the life-cycle of a trial.
GCP Compliance Manager
Our DDU GCP Compliance team coordinates the unit’s quality management systems. The senior DDU compliance manager maintains a comprehensive suite of DDU standard operating procedures, undertakes routine and ad-hoc internal quality control audits and facilitates audits and inspections by sponsors and external agencies. During set-up and throughout the lifecycle of all trials, the GCP Compliance Manager can provide records of staff GCP training, protocol-specific training and access to SOPs as required.
DDU Finance Officer
The Finance Officer ensures that all trials are appropriately costed at the outset and that these costs are appropriately invoiced to sponsors/CROs throughout the trial lifecycle in compliance with the Clinical Trials Agreement (CTA).