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0. Foundations of Medicine > Clinical Trials > Flashcards

Clinical Trials Flashcards

1
Q

<p>What do clinical trials provide evidence of?</p>

A

<p>Drugs are safe and effective</p>

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2
Q

<p>How many prescriptions do GPs give out per day on average?</p>

A

<p>70</p>

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3
Q

<p>How much does the NHS spend on drugs each year?</p>

A

<p>£11.7 billion</p>

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4
Q

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

A

<p>Warfarin and digoxin which is why they have so many side effects</p>

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5
Q

<p>What is an observational study?</p>

A

<p>Observes individuals without manipulation or intervention</p>

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6
Q

<p>What are some problems with observational studies?</p>

A

<p>False positives</p>

<p>Replication is difficult due to bias/different criteria</p>

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7
Q

<p>What do clinical trials prove (in terms of putting theory into practice)?</p>

A

<p>What works in theory might not work in practice</p>

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8
Q

<p>Why does the process of getting a drug onto the market take years?</p>

A

<p>Need to go through all of the stages to be approved for a license</p>

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9
Q

<p>Who are clinical trials regulated by?</p>

A

<p>MHRA</p>

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10
Q

<p>What is tested during clinical trials?</p>

A

<p>Safety</p>

<p>Efficacy</p>

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11
Q

<p>How is the efficacy of a drug compared?</p>

A

<p>With placebo or another drug</p>

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12
Q

<p>What are some laws which cover drug trials?</p>

A

<p>UK Medicines Act 1968</p>

<p>The Medicines for Human Use (Clinical Trials) Regulations 2004 and 2014</p>

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13
Q

<p>What are the stages of drug development?</p>

A

<p>1) Drug discovery</p>

<p>2) Pre-clinical development</p>

<p>3) Clinical development</p>

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14
Q

<p>What is tested during pre-clinical development?</p>

A

<p>Amimal pharmacology</p>

<p>Animal toxicity</p>

<p>Tissue culture</p>

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15
Q

<p>What are the stages of clinical development?</p>

A

<p>1) Phase 1 (volunteer studies)</p>

<p>2) Phase 2 (given to patients)</p>

<p>3) Phase 3 (formal therapeutic trials)</p>

<p>4) Phase 4 (post marketing surveillance)</p>

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16
Q

<p>What is tested during phase 1 trials?</p>

A

<p>Clinical pharmacology in normal volunteers</p>

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17
Q

<p>How many subjects are used in phase 1?</p>

A

<p>100</p>

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18
Q

<p>What happens during phase 2?</p>

A

<p>Clinical investigations in patients to confirm kinetics and dynamics</p>

<p>Evidence of efficacy and likely dosage range</p>

19
Q

<p>How many subjects are used during phase 2?</p>

A

<p>Up to 500</p>

20
Q

<p>What happens during phase 3?</p>

A

<p>Formal therapeutic trials establish efficacy and evidence of safety</p>

<p>All data submitted as an application for a license to sell the drug</p>

21
Q

<p>How many subjects are used during phase 3?</p>

A

<p>1000 - 3000</p>

22
Q

<p>What happens during phase 4?</p>

A

<p>Post marketing surveillance to produce evidence of long term safety</p>

23
Q

<p>How many people can phase 4 involve?</p>

A

<p>Tens to hundreds of thousands</p>

24
Q

<p>When do tegenero trials happen?</p>

A

<p>During phase 1</p>

25
Q

<p>What are tegerno trials?</p>

A

<p>Involves 8 patients:</p>

<p></p>

<p>6 given drug intravenously</p>

<p>2 given placebo</p>

26
Q

<p>What do pilot studies test and what do they not test?</p>

A

<p>They do not test outcome but test the study design</p>

27
Q

<p>What are examples of different pilot studies?</p>

A

<p>Double blind</p>

<p>Single blind</p>

<p>Prospective</p>

<p>Retrospective</p>

28
Q

<p>What is a double blind study?</p>

A

<p>Patient and doctor are blinded</p>

29
Q

<p>What is a single blind study?</p>

A

<p>Patient is blinded</p>

30
Q

<p>What is a prospective study?</p>

A

<p>Protocol is decided beforehand</p>

31
Q

<p>What is a retrospective study?</p>

A

<p>Looks backwards and examines exposure to risk factors in relation to outcome that are established at the start of the study</p>

32
Q

<p>What can different studies involve comparisions with?</p>

A

<p>Placebo</p>

<p>Other therapy</p>

<p>Cross over design</p>

33
Q

<p>What is a cross over design?</p>

A

<p>Patient is given additional treatment which is being tested</p>

34
Q

<p>What is a randomised control study?</p>

A

<p>One where patients are assigned to one of the groups at random</p>

35
Q

<p>What are some disadvantages of randomised control?</p>

A

<p>Generalised (subjects may not represent patient population)</p>

<p>Recruitment (twice as many new patients needed for the study)</p>

<p>Acceptability (some physicians or patients will refuse)</p>

<p>Administrative complexity (randomisation methods etc)</p>

36
Q

<p>What does superiority design show?</p>

A

<p>New treatment is better than the control or standard treatment</p>

37
Q

<p>What does non-inferiority design show?</p>

A

<p>Not worse than standard treatment by more than some margin</p>

<p>Would have beaten placebo if it had been included</p>

38
Q

<p>What should the end points of a design be?</p>

A

<p>Simple, such as:</p>

<p></p>

<p>Death</p>

<p>Number of hospital admissions</p>

<p>Lowering of blood pressure</p>

39
Q

<p>What do you need to consider when designing a study?</p>

A

<p>Choice of subjects (enough to be able to detect or reject differences between groups)</p>

<p>Choice of control drug (placebo or another drug)</p>

<p>Choice of patients (age, race, sex, diseases and drugs)</p>

<p>Exclusion and selection criteria (pregnant woman, children, seriously ill patients, elderly)</p>

40
Q

<p>What are challenges with trials that involve the elderly?</p>

A

<p>They usually have multiple conditions</p>

41
Q

<p>What do you need to consider when analysing and interpreting data?</p>

A

<p>Statistical test</p>

<p>Are differences due to chance</p>

<p>O<0.05 usually taken as significance</p>

42
Q

<p>What are some ethics that must be considered?</p>

A

<p>Consent</p>

<p>Ethics committee</p>

<p>Placebos</p>

<p>Children</p>

43
Q

<p>How long can overall development of the drug from initial research to its first launch take?</p>

A

<p>Up to 20 years</p>

44
Q

<p>What is post marketting surveillance done by?</p>

A

<p>Medicines and Healthcare devices Regulatory Authority (MHRA)</p>

<p>Yellow card system</p>

0. Foundations of Medicine (167 decks)

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