Page 1 of 4
What is a Clinical Trial?
- A test of a new intervention or treatment on people.
- To allow medical professionals and patients to gain information about the benefits, side effects and possible uses of new drugs as well as new ways to use existing drugs.
- To translate results of basic scientific research into better ways to prevent, diagnose, or treat cancer.
- We need to know that any treatments we recommend are both safe and effective in humans.
- Cell culture and animal work can only take us so far!
- Especially in Oncology, people are always looking for the miracle cure-and it is easy to get dragged into the idea.
- Scientific, medical, evidence-based paradigm.
- Treatment Trials.
- Prevention Trials.
- Early-detection Trials/Screening Trials.
- Diagnostic Trials.
- Quality-of-life studies/supportive care studies.
- Genetic Trials.
- It can be a phase I, II or III trial.
- It can be randomized or not.
- It can be blinded or not.
- It can involve a placebo or not.
- And it can be a pilot study or not.
- 15-30 people
- Determines
- What dose is safe.
- How the treatment should given.
- How the treatment affects the body.
- Safety.
Phase II
- Less than 100 people.
- Determines
- Whether the treatment does what it is supposed to.
- How the treatment affects the body.
- If the drug or intervention has an effect on the cancer.
- Does not compare with other treatments.
