Module 4

Question 1

What is experimental research?

Answer 1

Testing hypotheses in a controlled env’t (with or without humans)

Question 2

Why is experimental research important?

Answer 2

For discovering/using new therapies (interventions, medical devices, drugs)

Question 3

What are the three founding principles of experimental research?

Answer 3

Randomisation, local control, replication

Question 4

What are the main purposes of conducting experimental research?

Answer 4

Discovery, evaluating efficacy and establishing safety (often involves animal models and use of approach in ideal situation to determine efficacy), monitoring effectiveness in real world (including economic considerations)

Question 5

What is the focus of basic research?

Answer 5

Discovery

Question 6

What is the focus of preclinical studies?

Answer 6

Evaluating efficacy and safety

Question 7

What is the focus of clinical trials?

Answer 7

Evaluating effectiveness of intervention in humans

Question 8

What are the main steps within experimental research application processes?

Answer 8

1. Discovery (basic research)
2. Development (basic research)
3. Preclinical studies
4. Clinical trials
5. Benefit-risk assessment