
Where a cancer trial
begins
The Cancer Theme turns a clinician's idea into a running study. We help secure funding, write the protocol with our statisticians, build the database that captures every result, and set up sites across the UK — with coordinators and monitors keeping each trial on track from concept to first patient.
Built to the rigours of GCP
Compliance isn't bolted on at the end — it's designed in from the first draft of a protocol. Every trial we build conforms to ICH Good Clinical Practice and the UK regulations that govern clinical research, so the data it produces stands up to scrutiny.
Good Clinical Practice
Protocols, roles and processes are built to ICH-GCP. Decisions are documented, version-controlled and carried out by staff whose GCP training is kept current.
Clinical Trials Regulations
Trials of medicines (CTIMPs) are designed under the Medicines for Human Use (Clinical Trials) Regulations, with Clinical Trial Authorisation sought from the MHRA.
Ethics & HRA approval
Every study is reviewed by a Research Ethics Committee and granted Health Research Authority approval before a single site is allowed to open.
Data integrity by design
Databases are validated with full audit trails, so trial data stays Attributable, Legible, Contemporaneous, Original, Accurate — and complete.
Data protection
Participant data is pseudonymised, access-controlled and handled under UK GDPR and the Data Protection Act, with information governance built into every spec.
Registration & transparency
Studies are publicly registered and their results reported. Our monitors then provide risk-adaptive oversight and source data verification throughout.
How a trial comes to life
Long before anyone is approached to take part, a trial is designed and built here — and we stay with it long after. This is the path we take a chief investigator's idea along: from concept, through a study running across the UK, to a clean close-out and a secure archive.
Concept
A local chief investigator brings us a research question. We test its feasibility and shape it into a study the Centre can deliver.
Funding
We help build the case and apply for grants — NIHR, Cancer Research UK and others — so the trial has the resource to run properly.
Protocol
Working with our statisticians, we write the protocol: the question, the endpoints, the sample size and the analysis plan.
Database build
Data specialists turn the protocol into specifications. Programmers build the database and EDC forms that will capture every result.
Site set-up
Coordinators, under our senior coordinators, open the trial at one or many UK sites and green-light it to start recruiting.
Ongoing coordination
With the trial open, coordinators keep it running day to day — managing recruitment, amendments, queries and supplies across every participating site.
Oversight
Monitors provide independent oversight and source data verification, keeping the running trial safe, clean and on protocol.
Close-out
Once recruitment and follow-up finish, sites are closed down, the database is locked, and the final data is cleaned and analysed to answer the question.
Archive
The trial master file and study data are securely archived for the required retention period, so the trial stays auditable long after it ends.
Rigorous, collaborative, open
The Cancer Theme designs and sets up trials — we don't see patients in clinic. Our job is to make sure that every study built here is scientifically sound, well funded and ready to run before the first participant is approached.
Rigorous
Protocols are written hand in hand with our statisticians. Every endpoint, every sample size and every analysis is justified before a trial opens — so the answer it gives can be trusted.
Collaborative
A trial starts with a chief investigator's idea. We bring funders, statisticians, data specialists and programmers around that idea, and coordinate one or many UK sites to deliver it.
Open
Designs are registered and transparent. The data specifications we write travel with the trial, and our monitors provide independent oversight and source data verification throughout.
Meet the people
Designing and setting up a trial takes a close-knit team. Use the arrows to meet the roles behind every study we build.
Example peopleThe portfolio at a glance
A live snapshot of the trials the Cancer Theme is designing and setting up — where each one sits in the pipeline, the cancer areas they cover, and the mix of trial phases.
Example data- Phase I 4
- Phase II 9
- Phase III 6
- Observational 5
What's new in the Cancer Theme
Funding wins, protocols approved and databases going live — the milestones that move a trial from idea to open.
Example news