Clinical Trials Academic Notes

1. How many types 3 of adverse reactions are there? 2. What is Type C Continuous reactions resulting from long term use of the adverse reaction drug 3. What is Type D adverse reactions Delayed reactions not observed until months/ years following drugs use 4. what is type E ad- End of use reactions leading to various types of withdrawal verse reactions syndromes. 5. What information The compounds likely stability, dosage form, efficacy and does preclinical toxicity testing of a drug produce? 6. Who are phase 1 Young healthy men clinical trials given too? 7. What does phase The safe and appropriate dosage in humans 1 clinical trails determine? 8. What's the differ- 1a has 40 - 60 ppl ence between 1a 1b has 30-50 ppl and 1b clinical tri- 1b also looks at escalating repeat doses als? 9. Whats the data collected by phase 1 clinical trials? Adverse effects Pk parameters Pharmacodynamic measures 10. Who are phase 2 clinical trails done on patients 1/3 11. What's the aim Early exploratory and dose-finding studies in patients for phase 2 clini- Evaluates the effectiveness of the drug and identifies any cal trails potential side effects 12. what does an open label trial mean Non blinded 13. What is the aim for 2b clinical trails Confirmatory Dose selection to support registration 14. What data is col- Patients with one or more indications• lected at phase Selected dose levels/regimens compared to placebo 2b Randomised• Double-blind 15. What's the aim Large-scale studies in patients for phase 3 clini- Evaluates the effectiveness of the drug compared to stancal trials dard treatments Results from this stage are reported in peer-reviewed scientific journals and professional meetings 16. Who are the sub- Patients with target indication(s) but including different jects in phase 3 groups (age, ethnicity, etc.)• Selected dose level compared to placebo 17. What's the aim of Post-marketing surveillance (safety monitoring) of patients phase 4 clinical Often termed pharmacovigilance trails To reveal any adverse effects 2-4+ years onwards 18. Why is a black triangle on some new medication boxes? New medicines and vaccines that are under additional monitoring (high vigilance)have an inverted black triangle symbol (¼) displayed in their package leaflet and summary of product characteristic, together with a short sentence explaining what the traingle is there. 19. What is a comparative trial Also known as controlled trials, these make use of a comparative treatment to yield atreatment group (taking the 2/3 new drug) and a control group (given standard treatmentor placebo). Following this approach allows you to evaluate if a new drug is superior to existing treatment. 20. What's a parallel used in clinical trials which compares 2 treatments group study? 21. What is ranHelps guarantee the statistical validity of the results. domised trails Ppl randomly placed into groups so groups have a similar and what do they mix and removes investigator bias help guarantee? 22. What is a blinded A study whereby people taking part in the trial are not told trial which group they are placed into. If they were told this might influence how they feel during "treatment" or how theyreport their symptoms 23. What is a type 1 false positive error? Is where the trial reports a difference between treatment A and B, where noneactually exists 24. What is a type 2 false negative error Is where no difference is found between treatment groups where one actually does exist (more dangerous) 25. what type of ppl Significantly high BMI w.r.t. age and / or sex Clinically relecan not join a vant cardiovascular abnormality (ECG, B.P. or heart rate) clinical trail? Allergies relevant to the study (e.g. known drug hypersensitivities, skinallergies, etc.) Medical history of conditions relevant to the study situation Clinically relevant signs or symptoms at screening examination Evidence or relevant history of drug or alcohol abuse Evidence or history of any condition that could adversely absorption of thedrug, if administered orally 3/3