Information for Investigators - Work with OCTO
The development and delivery of clinical trials is taking place in what can seem like a complex environment. OCTO has, over the past 20 years, proven itself able to continuously adapt and innovate to rise to the challenges of running a wide range of projects:
- CTIMPs, non-drug studies, device trials
- Single centre, multi centre and international
- Working with many different funders: commercial and non commercial funders (or a combination of the two)
- Most of our trials are sponsored by Oxford University but we have worked with external sponsors too.
- Welcome opportunity to work with Chief Investigators external to Oxford University
When you work with us you will working with a CTU with the professional expertise you require for the development and delivery of your clinical trial in an academic research environment.
OCTO is part of the UKCRC Registered Oxford Clinical Trials Research Unit
If you would like to an initial discussion about bringing your trial to OCTO please contact the OCTO Administrator via email and we can arrange this: email@example.com
What can you expect from us?
Trial management is a collaborative process in which the relationship between the clinician and trial management team thrives on good communication. You can expect proactive, pragmatic and proportionate trial management from a team of experienced trial management professionals.
What’s the first step?
It is never too early to talk to us about a new trial idea. You do not need to have a draft protocol, in fact, we’d prefer that you didn’t! Some of the most important design and decision making work needs to take place before a protocol is even drafted.
New trial proposals are reviewed at our Clinical Trial Development Group and we recommend that you contact us at least 12 weeks prior to a funding application.
If a new trial joins our pipeline, a senior trial manager (Portfolio Lead) and a statistician will work with you to develop the trial design and operational plan, to determine what funding will be required and to make appropriate funding applications.
During this process we will cost all activities required to deliver a trial: core trial management; per patient costs payable to NHS sites; study supplies; costs associated with the collection of any biological samples etc.
We can help identify laboratories or other third parties to provide services or supplies, completing due diligence checks as required. This is particularly important for analysis of any biological samples to be used for assessment of primary or secondary endpoints, or to determine participant eligibility. It is also important that all steps of the supply chain are considered for supply of investigational medical product in a CTIMP.
For more information on costing your trial please refer to the How much will my trial cost section.
Investigators should to engage with patients and the public at an early stage, we can help you to contact relevant groups or individuals for Patient and Public Involvement (PPI) input.
Running the trial
Once funding has been confirmed we will work with you to ensure that the protocol and submission packages (for ethics and, where required, MHRA) are developed rapidly, in line with the agreed budget, applicable legislation and good practice. We will undertake a risk assessment to help ensure the trial runs smoothly and compliantly. In parallel we will ensure that study sites are set-up for recruitment, supply systems are established, that data management and safety reporting systems are established, and that other aspects of the Trial Master File are in place. We will liaise with other University teams such as contracts and the sponsor office.
Key to the success of any trial is the relationship between the Chief Investigator and the trial management team. Regular and responsive communication means we can quickly respond to any issues or opportunities that may arise as the trial progresses.
Throughout we will ensure that you receive regular reports on recruitment, data completeness and other information important for evidence the safe and compliant delivery of your trial.
At the end of the trial
After the last patient has completed per protocol follow-up we will work with you to ensure:
- All data cleaning is complete and the final data set is locked for analysis
- Closure of all participating NHS study sites
- Close of out any third-party suppliers
- Final reports submitted as appropriate to the study e.g. REC, MHRA, funders, stakeholders, and to trial registries where appropriate.
- Ensure that the Trial Master File is locked and archived as required by the sponsor and applicable regulations.
Services and support which OCTO cannot provide
OCTO does not have its own laboratory facilities and so cannot perform laboratory-based analyses for a trial. We will work with a Chief Investigator to identify appropriate third parties including laboratories. Where required we will ensure that the laboratory is appropriately resourced and structured for the required purposes, and will oversee performance throughout the study, ensuring relevant information is collected and recorded within the Trial Master File.
Investigational Medical product and other supplies
OCTO will work with a Chief Investigator to identify appropriate third parties or provide services for the manufacture and supply of products required within the protocol. Where required we will ensure that selected parties are appropriate and able to fulfil the responsibilities delegated to them by the sponsor. During the trial OCTO will monitor the activities of the third party, ensuring relevant information and documentation is recorded within the trial master file.
Out of hours/24 hours support
Clinical care of patients on trials remains the responsibility of participating study sites and their clinical teams. A trial Risk Assessment will determine whether an out of hours service is necessary for queries specific to a trial protocol but this is rarely required.