Podcast
Questions and Answers
What is the main purpose of clinical trials?
What is the main purpose of clinical trials?
Who typically designs clinical trials?
Who typically designs clinical trials?
What was the outcome of the 1747 scurvy trial by James Lind?
What was the outcome of the 1747 scurvy trial by James Lind?
What is one of the potential consequences of not conducting clinical trials?
What is one of the potential consequences of not conducting clinical trials?
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What was the first randomized controlled trial for?
What was the first randomized controlled trial for?
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What is a key characteristic of clinical trials?
What is a key characteristic of clinical trials?
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What is the primary purpose of conducting a clinical trial in its first stage?
What is the primary purpose of conducting a clinical trial in its first stage?
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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?
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What is the primary reason for conducting a clinical trial in its fourth stage?
What is the primary reason for conducting a clinical trial in its fourth stage?
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What is the estimated average cost of administering a 5.5-year clinical trial involving collecting data across 20 centers in the UK?
What is the estimated average cost of administering a 5.5-year clinical trial involving collecting data across 20 centers in the UK?
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What is the estimated cost of taking a drug from development to the market in the UK?
What is the estimated cost of taking a drug from development to the market in the UK?
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What is the proportion of drugs that make it through to stage 4 in clinical trials?
What is the proportion of drugs that make it through to stage 4 in clinical trials?
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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 covers the reasons clinical trials are used, their benefits, and the history of clinical trials, including the first clinical trial in the modern era.
