Clinical Trials Flashcards Preview

Principles of Disease > Clinical Trials > Flashcards

Flashcards in Clinical Trials Deck (45)
Loading flashcards...
1

What do clinical trials provide evidence of?

Drugs are safe and effective

2

How many prescriptions do GPs give out per day on average?

70

3

How much does the NHS spend on drugs each year?

£11.7 billion

4

What are examples of drugs that were developed before clinical trials were required, what does this explain?

Warfarin and digoxin which is why they have so many side effects

5

What is an observational study?

Observes individuals without manipulation or intervention

6

What are some problems with observational studies?

False positives

Replication is difficult due to bias/different criteria

7

What do clinical trials prove (in terms of putting theory into practice)?

What works in theory might not work in practice

8

Why does the process of getting a drug onto the market take years?

Need to go through all of the stages to be approved for a license

9

Who are clinical trials regulated by?

MHRA

10

What is tested during clinical trials?

Safety

Efficacy

11

How is the efficacy of a drug compared?

With placebo or another drug

12

What are some laws which cover drug trials?

UK Medicines Act 1968

The Medicines for Human Use (Clinical Trials) Regulations 2004 and 2014

13

What are the stages of drug development?

1) Drug discovery

2) Pre-clinical development

3) Clinical development

14

What is tested during pre-clinical development?

Amimal pharmacology

Animal toxicity

Tissue culture

15

What are the stages of clinical development?

1) Phase 1 (volunteer studies)

2) Phase 2 (given to patients)

3) Phase 3 (formal therapeutic trials)

4) Phase 4 (post marketing surveillance)

16

What is tested during phase 1 trials?

Clinical pharmacology in normal volunteers

17

How many subjects are used in phase 1?

100

18

What happens during phase 2?

Clinical investigations in patients to confirm kinetics and dynamics

Evidence of efficacy and likely dosage range

19

How many subjects are used during phase 2?

Up to 500

20

What happens during phase 3?

Formal therapeutic trials establish efficacy and evidence of safety

All data submitted as an application for a license to sell the drug

21

How many subjects are used during phase 3?

1000 - 3000

22

What happens during phase 4?

Post marketing surveillance to produce evidence of long term safety

23

How many people can phase 4 involve?

Tens to hundreds of thousands

24

When do tegenero trials happen?

During phase 1

25

What are tegerno trials?

Involves 8 patients:

 

6 given drug intravenously

2 given placebo

26

What do pilot studies test and what do they not test?

They do not test outcome but test the study design

27

What are examples of different pilot studies?

Double blind

Single blind

Prospective

Retrospective

28

What is a double blind study?

Patient and doctor are blinded

29

What is a single blind study?

Patient is blinded

30

What is a prospective study?

Protocol is decided beforehand