Criteria for securing York Trials Unit collaboration

The success and reputation of York Trials Unit depends on the quality and relevance of the trials we work on. We aim to work collaboratively with investigators in a way that ensures that both parties share their expertise most productively.

When to contact us

We advise researchers and clinicians who want to work with YTU to contact us as early in the process as possible. Ideally this should be at least eight weeks before a research grant deadline. This will allow us enough time to review your proposal, add our knowledge and experience to it, and to gain the required University of York approvals. Proposals with very short deadlines will likely result in YTU being unable to collaborate. Ongoing discussions or changes to aspects of the planned trial may require longer timescales and a later deadline than initially planned.

Criteria

We take considerable care when determining which trials YTU can engage with and base this on capacity and the following criteria:

Addresses an important question: The proposed study must address an important question. For example, if the trial is successful, there will be a reasonable expectation of the findings resulting in a worthwhile change in practice or policy.

Identified gap in knowledge: For example; a high quality systematic review supports the need for a trial.

Appropriate research team: The project team has an appropriate skill mix, and there is clear agreement about the role of YTU.

Potential to secure funding: There should be identified potential sources of funding. For example, a commissioned or themed call, or identified priorities for the NHS or other organisation.

Feasible: Many trials fail to recruit the required number of participants, for example, so there should be a well thought out strategy for demonstrating that it is feasible to recruit and retain participants. This might include conducting feasibility or pilot work. In addition, timeframes for protocol development and grant application should be realistic.

Financially viable: Our involvement in the study must be appropriately financed, with an expectation that YTU recovers the true cost of its engagement in the study - in terms of staff costs and consumables. We seek to cost grant applications at a level that ensures that the study can be run in accordance with our Standard Operating Procedures and registered status. If the costing is not sufficient for us to be able to add value to the study, we reserve the right to re-evaluate the collaborative status of the project.

YTU Staff involvement: For the majority of trials, we provide help with the development and design, while also overseeing randomisation, trial management, data management, analysis and reporting. However, we will consider - on a case by case basis - collaboration on certain aspects only.

Contributes to the YTU portfolio: YTU will assess its engagement in the trial based on whether it contributes to the YTU portfolio of high quality, relevant and methodologically excellent studies. YTU will consider each trial on its merits but particular attention will be paid to studies which are likely to explore methodological advances, add coherence to YTU’s research portfolio and enhance the Research Strategy plan of the Department of Health Sciences.

Our pledge: We will aim to meet the grant deadlines agreed at the time of the initial decision to collaborate. However, should this become unsustainable we will advise investigators accordingly as soon as this becomes clear.