Clinical trials aim to investigate new treatment options for various disease. In a cancer trial for example, investigators may measure the size of a tumour before and after treatment, then determine whether the experimental drug has affected the tumour size over a certain period of time. The possibilities for scientific research within clinical trials are limitless.
Clinical Trial Phases
Clinical trials typically are divided into 3 Phases: I, II and III
- Phase I trials investigate the safety of the experimental drugs on live tissue (in-vivo) or outside live tissue on fixed samples (ex-vivo)
- Phase II trials involve patients and aim to establish whether an experimental drug has efficacy and whether it is tolerable (are there nasty side effects?)
- Phase III trials are the final, most complex stage and provide the strongest indication of the drug’s efficacy and safety. These studies can involve several institutions across multiple countries. Cohort sizes can be up to tens of thousands of participants and are designed to be representative of the population
Clinical Trial Endpoints
Endpoints are ‘aims’ or ‘goals’ of a study. Some common endpoints used in clincial trials investigating a new cancer drug include:
- Disease-free survival (DFS): Time between the end of treatment and relapse of the disease
- Overall survival (OS): Time between the start of treatment and death
- Quality of Life (QoL): How the treatment affects daily functioning and overall well-being
- Safety: What side effects occur? Are they manageable?
Clinical trials are key to drug development
These studies allow scientists and researchers to better understand complex diseases and discover new, effective and tolerable treatments for thousands of diseases.
Next…
Click here to learn a little about what cancer is, how it develops and current treatments available.
References
- NIH. Available at: https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies. Accessed 2024.
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