Introduction To Clinical Trials Flashcards
What is a clinical trial?
Any research study that prospectively assigns human participants or groups of humans to one or more health- related interventions to evaluate the effects on health outcomes.
What are the purposes of Clinical trials?
- Testing new interventions
- Repurposing existing interventions for new indications
How many phases are in a clinical trial?
Phase 1, phase 2, phase 3, phase 4 and phase 0.
What is a phase 1 Clinical trial?
Number of volunteers = 50 to 200 healthy volunteers.
Main research question: related to safety
- Is the IMP safe in humans?
- Pharmacokinetics
- Pharmacodynamics
At this stage it’s mainly about safety and tolerability.
What is a phase 2 Clinical trial?
Number of volunteers = 100 to 400 patients with the target disease.
Main research question: same as phase 1
+
Would it work in patients?
What is a phase 3 Clinical trial?
what does it entail
Number of participants = 100 - 5000 depending on how common the disease is & existing treatment available)
Main research question is:
Similar to phase 1 and 2. But less PK and PD.
Would it work? (Efficacy)
What is a phase 4 Clinical trial?
Number of participants = 1000 to 1 million patients
Main research question:
- Safety in clinical practice
- Efficacy in Clinical practice
- Comparison to existing treatment
What is a phase 0 Clinical trial?
Used in oncology (cancer medicine)
Referred to as a ‘microdose’ study.
The research question:
Does The Drug bind to the target protein?
- Pharmacokinetics
What is a fair test?
A controlled investigation carried out to answer a scientific question.
What are features to reduce bias in Clinical trials?
Allocation of treatment
- Random
- Blinded - single, double, triple blind.
- Controlled - Placebo/comparator
What is the purpose of clinical trial regulations?
- Protect Clinical trials participants: rights, safety and welfare
- Quality assurance of data
- Harmonise and simplify administrative procedures.
Who authorises Clinical trials regulations?
- National competent authorities -MHRA (medicines and healthcare products regulatory agency)
- Ethics committee -HRA (health research authorities)
What is a sponsor in a drug trial?
An individual, company, institution, organisation / group of organisations that takes responsibility for initiation, management and financing (or arranging finance) of the research
Who is a chief investigator?
An individual who has overall responsibility for the conduct of the whole project in the UK.
Who is a principle investigator?
An individual responsible for the conduct of the research at a research site.
There should be one PI for each research site. In a single-site study the chief investigator and the PI will normally be the same person
