Conducting clinical trials in human participants helps determine the Safetyand Efficacyof the intervention for the new disease (indication) that has been repurposed for.
The gold standard in clinical trials is a randomised control trial (RCT), where participants are divided into 2 (or more) groups of equal size. One group take the investigational medical product (IMP) – in this case the repurposed drug – and the other group will either not take the drug, have the standard of care treatment or will take a Placebo in its place.
Though this is the gold standard for clinical trials, and the simplest proof of how effective the drug is (efficacy) for regulatory approval, it may not be the most effective or appropriate way to run a trial in all circumstances. Depending on the Patient cohort or the stage of development that you are in, alternative trial designs can be considered.
In this module you will:
- Consider what trial design, Outcome measures and strategy fit with your end goal
- Understand the key stages and requirements to set up a clinical trial
- Understand the key Stakeholders and their roles
The learning objectives of this module are:
- To understand the key procedures and documentation required for setting up a clinical trial
- To understand who act as important contacts within the clinical trial process, their roles and how they can support your trial
- To explore some of the different types of clinical trial and consider which may work for you
- To understand the patient experience of clinical trials and how to design a trial that meets their needs