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CRN North East and North Cumbria: Investigator Initiated Commercially Funded Research Studies (IIT) award guidance 2022/2023

Contents

The Award

Summary

This £5000 award is to support applicants from North East North Cumbria (NENC) to develop and lead on an Investigator Initiated Trial (IIT), as well as providing practical support to assist you in achieving Clinical Research Network (CRN) Portfolio status.

The Detail

An IIT (Investigator Initiated Trial) is a study led by an Investigator (e.g. NHS, University, Public Health or Social Care staff) with research funding (e.g. financial/equipment/software) provided by a commercial organisation specifically to support that study. NHS IITs are often supported by a commercial company such as a pharmaceutical, biotechnology or devices company. However, for non-NHS settings it could be any type of commercial organisation that provides support via the funding described. For IITs, an NHS Trust or other non-commercial organisation (e.g. University or Local Authority) is the Sponsor of the study.

NIHR Clinical Research Network North East and North Cumbria (CRN NENC) aims to:

  • Increase the volume of Investigator Initiated Commercially Funded Research Studies (IITs) taking place across the region.
  • Support the development of new Chief Investigators

Since 2017/2018 the CRN NENC Executive Board and MedConnect North have funded a total of 21 IIT projects. The awards aimed to ensure that individuals had recognition of work done to develop IIT research and supported the development of portfolio adopted IITs. In the short term this brought benefit in the form of recruitment and investment and has helped develop research skills, involvement and engagement with portfolio research. In the longer term we want to further support the development of applicants; specifically to facilitate future CI trials that lead to larger grant-funded or commercially funded projects.

Consequently, the NENC Executive Board and MedConnect North have agreed to run the scheme again. 5 awards of £5,000 will be available to support the development of new IITs, or to support the progression from current or recent IIT to research council funded or commercially sponsored study.

One of the awards is sponsored by MedConnect North and seeks to support an investigator working on a Medical Technology product.

Applications are open to anyone involved in health or social care research including previous applicants. Where an award was received in any of the previous years, applicants are expected to outline the next steps and detail how further funding will be used towards a larger study.

The award will be for a period of 12 months from January 2023 with funding provided to support the scheme up front. We will treat the award as being fully spent in-year however it is up to partner organisations how it is used to support the 12 month programme.


Criteria

This is a competitive funding award assessed against the following criteria:

Essential

  • The lead applicant is a professional in the CRN NENC region working in a Health, Public Health, Social Care or Academic setting
  • Formed research idea
  • Partner/funding agreed (commercial company) and written documentation of their funding contribution.
  • Proposed study to run in an NENC Partner Organisation, Public Health or Social Care setting.

Desirable

  • Unfunded to do research/without adequate Chief Investigator (CI) time included in any commercial grant/remuneration
  • Development of previously supported feasibility study (if applicable)
  • Multi-site within NENC

Support available

As part of the scheme, support will be available to help with completion of the award application. Please email nencstudies@nihr.ac.uk if you want to access support with your application.

In addition, we are hosting an IIT drop-in session on Teams on 10th October 2022 between 2 and 3 pm where you can join Clinical Lead, Stuart Watson and members of the MedConnect North and CRN teams - to ask any questions and to seek further help and guidance if required.

For Medical Technology studies, additional support can be provided from the MedConnect North Service including Research Operations Manager and Project Manager to assist with study design, grant writing and liaising with R & D. The MedConnect North Team can also make introductions to a Methodologist and Statistician if required (although there may be a cost for this time if anything other than a high level review is required).


Expected outcomes

All awardees will be required to update the CRN as to their progress at minimum 3 monthly intervals during the 12 month period. Awardees will be contacted by their Research Operations Manager.

The award is expected to increase research capacity via development of new, or progression from existing, IITs that have the potential to be adopted onto the NIHR Portfolio at the end of 12 months.


Applications

Applications will be via an online form and will require details of the proposal, how it meets the above criteria.

The team will review and assess applications against the criteria outlined above and will also discuss with R&D Managers/Directors before confirming the outcome of the application process.


Timelines for Applications

19/09/2022: Competition advertised and open to applications
11/11/2022: Closing date for applications
W/C 05/12/2022: Decision by panel on successful applications
15/12/2022: Funding sent out
July 2023: 6 month progress review
January 2024: Protocol Approval/Study Set-up due by
January 2024: Final Review


The application form can be found here.