Regulatory Links
Clinical Research
The MCRN works in close partnership with academic and NHS-based investigators to maximise the development of safe and effective medicines and formulations for children. The Network facilitates publicly-sponsored studies (whether the funding is from public or industry sources) in NHS sites serving approximately 12 million children. For details of how the MCRN supports industry-sponsored studies, please click here.
Please see the sections below and links from this page for information on:
- How can the MCRN assist my research?
- Study Development, Management and Other Advice
- Feasibility (Site Identification)
- Support for Study Delivery (inclusion in NIHR CRN Portfolio)
- Site Setup
- Recruitment
- Closure
How can the MCRN assist my research?
The MCRN supports researchers in a number of ways through its world-class infrastructure, which includes the MCRN Coordinating Centre, Clinical Studies Groups (CSGs), Clinical Trials Units (CTUs), Local Research Networks (LRNs) and a Neonatal Network. (CSGs are groups of key opinion leaders that provide advice, identify research priorities and design protocols to address these priorities. CTUs support all aspects of study design and management. LRNs and the Neonatal Network facilitate the conduct of studies across the NHS). For details of studies that MCRN is supporting already, please see click here. The MCRN also works with the CCRN Paediatrics (non-medicines) Speciality Group to support studies not involving medicines.
Study Development, Management and Other Advice
MCRN CSGs, CTUs and other staff can provide expert advice to help you develop study ideas into successfully funded protocols. Investigators are advised to contact MCRN as early in the study development cycle as possible. Advice can then be provided to optimize study design and feasibility. The MCRN can also advise on formulations and on consumer matters, including the preparation of patient information sheets. (Please see the CSG and CTU pages for further information and contact details).
Feasibility (Site Identification)
The Network can work with investigators to collect feasibility data from sites, if required. Following a top-level review of the study, the Network aims to return names/contact details of interested investigators (with an initial indication of numbers of patients that can be recruited) within 10 working days. The MCRN and the Association of Medical Research Charities (AMRC) have worked together to prepare a guidance document entitled "Points to consider when assessing the feasibility of research"
Support for Study Delivery (inclusion in NIHR CRN Portfolio)
To obtain MCRN support with site setup and recruitment, studies have to be included in the NIHR CRN portfolio. Standard NIHR CRN processes are followed, with studies being submitted to the "NIHR Coordinated System for gaining NHS Permission" (NIHR CSP) to initiate the NHS R&D approvals process. Subsequently, the MCRN Study Assessment Committee (SAC) assesses issues pertaining to study feasibility/delivery (and adoption status if not automatically eligible). The Committee meets every two weeks to consider studies so as to not delay study timelines. (Please see click here for further information and contact details).
Site Setup
The MCRN assists with site setup for studies included in the NIHR CRN Portfolio. MCRN staff work with investigators to assist:
- Local ethics and R&D approvals (in the context of CSP)
- Contracting
- Training: All staff associated with portfolio studies qualify for free NIHR CRN/MCRN training, including GCP courses.
The MCRN acts as the Lead Network as appropriate. Please click here for more details.
Recruitment
Following site setup, MCRN staff work with investigators/sites to ensure that studies are conducted rapidly to a high standard, in particular focusing on:
- Recruitment: MCRN staff help the recruitment of patients by providing support to site staff, including advice on recruitment strategies. The NIHR CRN portfolio database is used to monitor recruitment rates closely to ensure targets are met.
- Research nurse support: Local site nurses typically assist with study procedures, but in some cases, Network-based nurses may be available to perform roles, subject to existing demands on their schedules.
- Data collection: staff can help with form completion/data submissions.
- Site support: If recruitment rates are below expectations, staff work with sites to identify and resolve constraints.
- New site identification: During recruitment stages, staff can identify additional study sites, if required.
For details of studies that MCRN is supporting already, please click here
Closure
Upon closure of the study, staff work to ensure that all regulatory and other requirements are addressed.
Questions?
If you have any questions about the support that the MCRN offers, please see the pages linked to this one for information and contact details.