Funding

It is important to consider how your clinical trials will be funded early on in the project (preferably at least one year in advance of when they will go ahead), as the process of applying for funding can be lengthy. It may be worth considering partnering with a grant-writing company when completing applications to ensure both the academic and lay sections of the application are accurately completed.

The MCDS-Therapy Project received funding from the European Union’s Horizon 2020 Research and Innovation Programme after applying to the Horizon 2020: personalised medicine call 2016–2017. Any group can apply to these calls, with the prerequisites that the drug must have been given orphan drug designation by the EMA and that the trial proposal takes into account recommendations given by the EMA during a protocol assistance meeting.

Clinical trial sponsorship and insurance

When planning for clinical trials, it is necessary to consider sponsorship and insurance as early as possible in the process to avoid delays.

Sponsorship and insurance for the MCDS-Therapy Project was provided by the Newcastle-upon-Tyne Hospitals NHS Foundation Trust. Obtaining this involved a lengthy process as the providers had limited familiarity with obtaining insurance for international trials.