Clinical Drug Trials Flashcards

Question

can adverse effects and toxicity also occur in patients taking placebos?

Answer 1

yes but they are usually subjective | upset stomach, insomnia, sedation

Answer 2

single--> only the health professional knows the identity of the treatment double--> neither the patient nor the health professional knows the identify of the therapy - third party holds the code identifying each medication packet - code is not broken until all the data has been recorded used to reduce subject bias

Answer 3

``` four phases (I-IV and sometimes phase 0) single or double blind random patients ``` design endpoints -primary outcome measure (occurrence of disease, symptom, sign or lab measurement) each trial is designed to include and exclude a population of patients based on specific criteria (age, gender, health status, stage of disease, previous drug regimens, history)

Answer 4

submission of the IND is how the investigators technically obtain permission from the FDA to distribute the drug 2 categories exist (commercial and non-commercial research) each category must contain preclinical data from animal pharm and toxicology studies, manufacturing info, clinical protocols, and investigator info federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines during clinical trials investigators must distribute it across state lines for patients across the country

Answer 5

instutional review board they are in existance to make sure that the safety, welfare and rights of humans are protected in the research they have the authority to approve, or require modification in or disapprove research

Answer 6

also known as independent ethics committee they are located at the facility where the clinical trial will be conducted

Answer 7

aka microdosing subpharm doses of prospective drug candidates are administered to human volunteers provides early pharmacokinetic date in humans only require minimal preclinical toxicology safety testing when in vitro and lab animal models are shitty, this phase can offer supportive and alternative data in order to pick a more suitable drug candidate cost is very minimal

Answer 8

first stage of drug testing in humans conducted to see if humans and animals have different responses to investigational drug and to establish the limits of safe clinical dose range small number of HEALthy volunteers (25-50) if the drug is going to cause significant toxicity (cancer therapy, or AIDS therapy) --> than volunteer patients with disease are included both investigator and subject know what is being tested absorption, 1/2 life, and metabolism are data reported performed in inpatient clinic at research centers

Answer 9

performed with a larger group that have the target disease (100-200 patients) single-blind design include inert placebo, an established active drug for positive control and the active investigational agent efficacy, dosing requirements, toxicities are detected and recorded performed in clinical centers --> hospitals affiliated w/ university drug failure typically occurs during phase II when the drug is discovered to be toxic or not efficacious at appropriate doses

Answer 10

performed when the effectiveness, dose and toxicities of the experimental drug are completed (with successful outcomes) group size is now larger 300-3,000 patients WITH the target disease crossover design and double-blind design are usually used in this stage intent--> more info about overall benefit-risk relationship of the drug and adequate basis for physician labeling carried out in settings similar to those anticipated for the ultimate use of the drug MOST expensive b/c large numbers of patients and lots of data that must be recorded and analyzed

Answer 11

application submitted by the manufacturer of a drug to the FDA (AFTER clinical trials) for a license to market the drug for a specified indication this has been the process since 1938 includes full reports of all preclinical and clinical data pertaining to the drug under review

Answer 12

for serious diseases--> still in phase III for life-threatening diseases--> still in phase II

Answer 13

starts only AFTER approval to market a new drug purpose: monitor the safety of the new drug under actual conditions of use in large numbers of patients if a drug has a side effect that occurs with an incidence of 1 in 10,000 pt's the post-marketing feedback is essential ! used with large numbers of patients which means that a rare drug-induced effect or toxicity can be identified no fixed duration!