introduction Flashcards
What is a Target Product Profile?
A Target Product Profile involves the components of the treatment and the desired/expected outcomes for the disease. This allows effective optimisation of drug candidates. Information included should be: the indications (e.g. what are the outcomes, relief of pain?), the target population, the delivery mode, the dosing frequency, the clinical efficacy, the cost, the stability, the safety (e.g adverse events).
What is a Clinical Development Plan?
The CDP essentially contains every planned aspect of the trial (e.g. basically everything). It ensures that there are reduced failures due to poor design, etc. Included should be: what the endpoint is, what the timeline is expected to be, what the outcomes are expected to be, who the team will involve, the rationale of the research/treatment, etc. Basically what was done in the assignment.
What are the 3 types of research?
- Basic - generally doesn’t involve living patients
- Applied - primarily involving human research, e.g. clinical research
- Translational - taking findings from basic and applied research and utilising them to provide innovation in healthcare settings.
What are the main funding bodies associated with funding basic research?
Medical Research Council (MRC) or The Wellcome Trust.
What are the main funding bodies associated with funding applied research?
National Institute of Health Research (NIHR), Charities (e.g. Cancer Research UK), Industry funded (e.g. Pharma companies like Roche), Academic funders (UK Clinical Research Collaboration), NHS funding
Who do the funding bodies report to?
The MRC report to the Department of Business Innovation and Skills. Charities report to the Department of Health.
Why might researchers want their projects to be eligible for the NIHR Portfolio?
Even if funding is received from MRC or other industries, programmes may be eligible for NIHR portfolio, meaning that they receive funding support for staff costs, infrastructure, and study management, etc.
What is an observational study?
These draw inferences from the possible effect of a treatment on subjects. They are not reliable to judge efficacy or safety, but are useful to provide real world data and allow hypothesis formulation for future studies.
What are fellowships for?
These are for providing support to researchers who may be in the early phases of their career, e.g. post-doc, to assist them with experience.
What are programme grants for?
These are for groups of researchers, led by a senior academic.
What are project grants for?
These are for experienced researchers who are renowned to deliver.
What is the Research Governance Framework?
The Research Governance Framework consists of 4 separate systems which provides principles on the good governance of research. However, now this is being overtaken by the HRA to produce a united system known as the UK Policy Framework for Health and Social Care Research. This has incorporated all systems to allow for a more streamlined uniform document promoting easier funding and trial conduct mechanisms for researchers.
