ICR-CTSU statement on clinical trials in light of COVID-19
The ICR-CTSU has the facilities to remain operative in light of the Government requiring widespread home working and travel restrictions. Our trial staff will remain contactable either via the trial proxy e-mail accounts or via the phone.
We will continue to offer a randomisation service to those sites that wish to continue to enter new patients into our studies. We recognise that sites may decide to put recruitment into a trial on hold and would ask that ICR-CTSU is notified if this is the case. Please note that it is not acceptable to by-pass eligibility processes due to difficulties in assessing subjects and carrying out tests. Patients should only be entered into a trial if all eligibility criteria can be confirmed.
Patients currently being treated on trial should continue to be treated according to the protocol. We will work with you to ensure that sufficient drug supplies are available to continue to treat patients if applicable.
Patient follow up by telephone is acceptable unless specific tests or assessments are essential to ensure continued safety. If the safety of a trial subject is at risk because key evaluations cannot be completed, then consideration of discontinuing that patient’s treatment must be discussed with ICR-CTSU.
Serious adverse events should be reported to ICR-CTSU’s dedicated e-mail account ([email protected]).
Data entry must continue for all studies to enable central monitoring of patient safety. Any missed assessments should be reported on the relevant CRF to enable us to document deviations. The MHRA has confirmed that increased numbers of deviations will not be considered reportable as a serious breach unless there is a specific safety concern.
We will be in touch with relevant site trial teams if there are any specific requirements for individual trials.
This guidance is current as of 19th March 2020. Clearly this is an evolving situation and we will revise our guidance as and when needed.
Our clinical trials
ICR-CTSU clinical trials focus on breast, urological and head and neck cancers, but we also run trials in other rarer cancer types including melanoma, sarcoma and ovarian cancer.
We specialise in phase II exploratory and phase III randomised trials of new treatments and technologies (including radiotherapy), and understanding cancer biology and treatment response using biomarker-driven trial designs is fundamental to our research.
See our full list of clinical trials for more information about the different clinical trials we run.
For patients and the public
To find out more about ICR-CTSU research, including how to become involved in clinical trials, please visit our patients and public page. In addition, most clinical trial pages include a link to the study’s plain English summary.
ICR-CTSU is a research-led, academic clinical trials unit (CTU) within the Division of Clinical Studies at the ICR. Our expertise spans the whole clinical trial life cycle.
We receive core funding from Cancer Research UK, are a UK Clinical Research Collaborative (UKCRC) registered CTU and one of 15 CTUs recognised by the National Cancer Research Institute (NCRI) for professional specialism in the development and delivery of cancer trials.
ICR-CTSU is committed to the responsible sharing of clinical trial data and trial samples with the wider research community in order to improve scientific and medical knowledge about cancer.
To enable data and samples to be effectively shared with others, an access policy and defined procedure exist to ensure that relevant legal, ethical and commercial constraints are recognised and that data and samples are made available for new research purposes in a responsible manner.
Please consult the data sharing page for further information.
If you are interested in working with us, please visit our collaborators’ page or explore current ICR vacancies.