Early phase studies and trials aimed at understanding mechanisms to inform the main study.The work supported by the first 25% tranche of funding could include: The main clinical evaluation must start within 18 months of the project start date and should account for more than 75% of the total project cost. Proposals may include two stages with progression to the main clinical evaluation dependent on the outcome of the previous stage, measured against predefined criteria. These studies use data or samples obtained and stored from both treatment and control groups of a clinical study, to arrive at conclusions that would not arise from a simple cohort study. Hypothesis-testing research based on an efficacy study, to explore the mechanisms of action of interventions, causes of differing responses or disease mechanisms.The evaluation of a broad range of interventions that have the potential to maintain health, treat disease or improve recovery. ![]() Research to determine proof of clinical efficacy, size of effect, and long-term safety in a well-defined population.EME or i4i? Would my primary research idea be of interest to the i4i or the EME Programme?.Guidance for identifying funding schemes for clinical studies.The following guides compare the remits of NIHR and MRC translational research programmes to help researchers to determine which funding scheme is the most appropriate for their proposed project: It will also consider studies that validate potential surrogate outcomes against a primary clinical outcome, within the main clinical trial. The programme will accept applications for studies that use clinical or well-validated surrogate outcomes. These can include qualitative research and opportunities for mechanistic work where the efficacy trial has not been successful. The programme will also support mechanistic studies that follow on from on-going or completed clinical studies funded by the NIHR which can use data or samples from these studies. These studies could explore the mechanisms of action of the intervention, the causes of differing responses, or promote an understanding of any potential adverse effects and how these could be reduced they could also contribute to understanding of the disease. ![]() Where appropriate, the programme encourages hypothesis-testing mechanistic studies integrated within the main efficacy study. Innovative study designs involving stratification, the use of routinely collected digital data or novel methodologies are strongly encouraged. The programme will only support studies where there is sufficient evidence that the intervention might work in man, i.e. The interventions should have the potential to improve patient care or benefit the public. The EME Programme primarily supports clinical trials, and other robustly designed studies that test the efficacy of interventions.
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