The MCRN works in close partnership with pharmaceutical, biotechnology, contract research organisation (CRO) and other companies to maximise the development of safe and effective medicines and formulations for children. The Network facilitiates company-sponsored studies in NHS sites serving approximately 12 million children. We support therapeutic clinical trials and pharmacokinetic (PK), pharmacodynamic (PD), pharmacovigilance and other studies in all disease areas (except oncology and some mental health studies that are facilitated by other Networks; please contact MCRN for advice). To-date (early 2013), the MCRN has supported close to 250 industry studies, with approximately 30% of international, multicentre studies recruiting their first global participant in the UK.
Recently, the work of MCRN and other NIHR organisations that support industry to deliver children’s studies has been highlighted in an NIHR brochure. Please click here to see the brochure and please forward on to any colleagues that you think would be interested. Please contact us if you would like printed copies.
The MCRN supports pharmaceutical/biotech companies and CROs in a number of ways through its world-class infrastructure, which includes the MCRN Coordinating Centre, Clinical Studies Groups (CSGs), Local Research Networks (LRNs)/Areas and a Neonatal Network. (CSGs are groups of key opinion leaders that provide advice, identify research priorities and design protocols to address these priorities. LRNs and Areas facilitate the conduct of studies across the NHS). Where appropriate, our interactions with companies are co-ordinated with Clinical Research Facilities (CRFs) and other networks. 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 (with devices, diagnostics etc).
MCRN CSGs and other staff can provide expert advice on the EU Paediatric Regulation/Paediatric Investigation Plans (PIPs) and the development of study protocols. Companies are advised to contact MCRN as early in the study/programme development cycle as possible. Advice can then be provided to give greater assurance on feasibility. The MCRN can also advise on formulations and on consumer matters, including the preparation of patient information sheets. (Please click the following for information on the EU Paediatric Regulation and specialities covered by CSGs).
The Network works with companies to rapidly collect feasibility data from sites, if required, following NIHR CRN processes. Please click here for information and a link to download the "NIHR CRN Trials Adoption Process and Feasibility Assessment Submission Form". Click here for information on confidential disclosure agreements (CDAs) and other useful documents.
The MCRN assists with study setup following site/country selection. MCRN staff work with companies and sites to assist:
Following site setup, MCRN staff work with companies and sites to ensure studies are conducted rapidly to a high standard, in particular focusing on:
Upon closure of the study, staff work with companies and sites to ensure that regulatory and other requirements are addressed.
The MCRN Industry Team is responsible for ensuring that the pharmaceutical/biotech industry can conduct studies effectively across the Network.
The team members are: