One of the key activities of c4c is to set up an advice process to facilitate expert advice, (Strategic Feasibility Advice) to c4c industry and academic beneficiaries on any aspect of a paediatric drug research and/or development project (e.g., study design including methodology, assistance with regulatory responses). More than 300 experts, within 24 Expert Groups, with expertise on innovative methodology and clinical expertise on paediatric trials, as well as parents and young patients are available to provide scientific advice for questions of requesters who are researching/developing medicines for children.
Depending on the nature of the request, experts are selected from appropriate Expert Groups to provide advice in a “Strategic Feasibility Advice Group meeting”. As of May 21st2021, 23 advice requests have been received. This includes 22 advice requests from industry and one from academia, of which 14 have been completed, 4 are ongoing and 5 did not proceed. Feedback from the advice requestors has been excellent. Requesters highly valued the high-quality input of various experts, some of whom would not have been identified without c4c, as well as the option to have patient/parent insights and methodology expertise included alongside the clinical expertise. c4c is working to ensure the advice service will continue to be part of the successor c4c organization, when the IMI2 funding has finished. This will ensure that better medicines are available for children through optimal, innovative and patient-centric study designs with a unique multidisciplinary framework.