Notes in 2- Clinical Trial Design

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Published	02/10/2024	Clinical trials are important because they provide the {{c1::evidence}} that clinical medicine is based around.
Published	02/10/2024	Drug treatments based on trial evidence: examples• Treatment of myocardial infarction • Treatment of stroke • Treatment of many cancers • Treatment…
Published	02/10/2024	Questions to consider when developing a drug:• Does it work? • What dose is therapeutic? • What dose is toxic? • Is it safe?i.e. does it cause teratog…
Published	02/10/2024	Pharmaceutical Product Development
Published	02/10/2024	Drug discovery• Serendipity (by chance) e.g. Penicillin • Active metabolites of existing drugs • Chemical alteration of compounds • Rational mole…
Published	02/10/2024	What happens in Pre-clinical development of a drug?
Published	02/10/2024	What happens in Phase I of clinical development?We've now determined in: Pre-clinical development → works well on animals
Published	02/10/2024	What happens in Phase II of clinical development?We've now determined in: Pre-clinical development → works well on animalsPhase I → volunteers ar…
Published	02/10/2024	What happens in Phase III of clinical development?We've now determined in: Pre-clinical development → works well on animalsPhase I → volunteers a…
Published	02/10/2024	What happens in Phase IV of clinical development?We've now determined in: Pre-clinical development → works well on animalsPhase I → vol…
Published	02/10/2024	Why are clinical trials regulated by the MHRA?
Published	02/10/2024	The problems with Observational Studies;[1] Correlation vs Causation→ False positives[2] Replication of observational studies is difficult due to {{c1…
Published	02/10/2024	Why do we do clinical trials?
Published	02/10/2024	{{c1::Pilot studies}} are small studies made not to estimate outcome, but to test study design.Types of clinical trials:– {{c2::Double blind}} – patie…
Published	02/10/2024	A {{c1::placebo}} is an inactive substance that looks like the drug or treatment being testedA {{c1::placebo controlled trial}} involves randomly assi…
Published	02/10/2024	A {{c1::crossover design}} is a repeated measurements design such that each patient receives different treatments during the diffe…
Published	02/10/2024	{{c1::Randomised}} Control Clinical Trial→ Patients assigned at random to either treatment(s) or control
Published	02/10/2024	What are the disadvantages of Randomised Control Clinical Trial?
Published	02/10/2024	Commonly Used Phase III Designs• Parallel • Withdrawal • Group/Cluster • Randomized Consent • Cross Over • Factorial • Large Simple • Equivalence/Non-…
Published	02/10/2024	{{c1::Superiority Design}}: Shows that new treatment is better than the control or standard (maybe a placebo){{c1::Non-inferiority Design}}: Shows tha…
Published	02/10/2024	What end-points should be considered when designing a study?e.g. Randomised double blind comparison of angiotensin II antagonist vs atenolol in the tr…
Published	02/10/2024	Designing a study:1- Hypothesis2- Endpoints3- Number & choice of subjects→ Need enough to be able to detect or reject a difference between the gro…
Published	02/10/2024	Challenges facing clinical trials:[1] declining {{c1::renal function}} with age[2] patients with {{c1::co-morbidities}}
Published	02/10/2024	Analysis and Interpretation of results:• Choose a statistical test• Are differences due to chance? • Interpreting an insignificant finding→ No di…
Published	02/10/2024	Ethics behind clinical trials:• Consent • Ethics committee→ look into the study • Placebos→ is it ethical to give placebos? • Children→ trials with ch…
Published	02/10/2024	Number of patients exposed to new drug→ increases after drug approval from regulatory bodies→ drug gets a patent (20y time)→ patent expiry
Published	02/10/2024	{{c1::Post marketing surveillance}} is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been re…
Published	02/10/2024	The {{c1::p-value}} helps us to decide if we have strong enough evidence to make conclusions about our data.The smaller the {{c1::p-value}}, the stron…
Published	02/10/2024	What does it mean if a p-value is less than 0.05?
Published	02/10/2024	What does it mean if a p-value is higher than 0.05?
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