Podcast
Questions and Answers
What is the main purpose of the FIRST stage of a clinical trial?
What is the main purpose of the FIRST stage of a clinical trial?
What is the main difference between a controlled trial and a blind trial?
What is the main difference between a controlled trial and a blind trial?
What is the main purpose of a clinical trial's FOURTH stage?
What is the main purpose of a clinical trial's FOURTH stage?
What was the main problem with the drug Thalidomide?
What was the main problem with the drug Thalidomide?
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What is the approximate cost of taking a drug from development to the market in the UK?
What is the approximate cost of taking a drug from development to the market in the UK?
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What percentage of drugs make it through to stage 4 in clinical trials?
What percentage of drugs make it through to stage 4 in clinical trials?
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What is one of the primary reasons clinical trials are used?
What is one of the primary reasons clinical trials are used?
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When was the first clinical trial in the modern era conducted?
When was the first clinical trial in the modern era conducted?
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What would be the consequence without clinical trials?
What would be the consequence without clinical trials?
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What are clinical trials designed to achieve?
What are clinical trials designed to achieve?
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Who generally design clinical trials?
Who generally design clinical trials?
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What do clinical trials generally start with?
What do clinical trials generally start with?
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Study Notes
Reasons for Clinical Trials
- Prevent disease and reduce the number of people who become ill
- Treat illness and improve or increase the number of people cured
- Improve the quality of life for people living with illness – reducing symptoms or side effects
- For disease diagnosis and health problems
History of Clinical Trials
- 1747: James Lind conducted the first clinical trial in the modern era on scurvy
- Early 1800s: The term "Placebo" was first defined
- 1943: The first double-blind controlled trial was conducted by the Medical Research Council
- 1946: The first randomized curative trial was conducted using Streptomycin to treat tuberculosis
Importance of Clinical Trials
- Without clinical trials, patients could be given medicines that do not work
- Resources could be wasted on ineffective treatments
- Medicines could even make the patient worse
Design of Clinical Trials
- Designed to offer the least risk to the patient but maximum potential new treatment or intervention being tested
- Generally designed by doctors and specialists
- Start with a systematic review of previous trials performed in the same area of disease or using similar drugs
Phases of Clinical Trials
Early Stage (Phase 1)
- Tests the safety of the treatment in small groups of healthy subjects or patients
- Assesses large side effects
Second Stage (Phase 2)
- Tests the treatment in a larger group of people to assess safety and side effects in greater detail
- Assesses the treatment's positive effect in patients
Third Stage (Phase 3)
- Tests the treatment in hundreds or thousands of people, often internationally
- Compares the new drug to a standard treatment
- Assesses the drug's effectiveness and duration of effects
- Finds out more about serious side effects and their duration
Fourth Stage (Phase 4)
- The drug is licensed and used as a treatment
- Collects data on the drug's effectiveness in a large population
- Monitors long-term risks and benefits, including rare side effects
Types of Clinical Trials
Controlled Trial
- Compares different treatments
- Involves two groups: a trial group and a control group
Blind Trial
- Participants do not know which group they are in
- Some trials are double-blinded, meaning both participants and researchers do not know which group they are in
Assessments in Clinical Trials
- Potential side effects
- New symptoms
- Quality of life, day-to-day activities, and mental state
- Cost effectiveness of treatment, including the ability to work and visit the doctor
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Description
This quiz assesses understanding of the reasons and importance of clinical trials in medical research. It covers the benefits of clinical trials, including disease prevention, improving quality of life, and diagnosis. The quiz also touches on the history of clinical trials, dating back to James Lind's scurvy trial in 1747.
