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level: Level 1 of Clinical Trials

Questions and Answers List

level questions: Level 1 of Clinical Trials

Question	Answer
Type of research that studies new tests and treatments and evaluates their effects on human health outcomes Carefully designed, reviewed and completed, and need to be approved before they can start. People of all ages can take part in, including children. are conducted to collect data regarding the safety and efficacy of new drug and device development.	CLINICAL TRIALS
CONSIDERATIONS FOR CLINICAL TRIALS	1st: Pharmacologic profile is equal or better than existing competitors 2nd: Address unmet medical or improve therapy 3rd: Market potential sufficient to sustain profitability 4th: Risk factors are assessed 5th: Potential expenses 6th: Success in the marketplace
refers to studies, or trials, that are done in people	Clinical research
TRIAL OBJECTIVES	Phase I- limited to determining toxicity at a range of dosages Terminal illnesses- efficacy assessment Phase Il and III- Clinical efficacy in large sample of patients Phase IV- Assess efficacy and side effects in specific patient population
COMPONENTS OF A TRIAL OBJECTIVE	1 Approach of the trial (to compare; asses and evaluate) 2 Specific disease 3 Types of patients 4 Drug therapy(ies) 5 Dosage
used to compare different types and combinations of drug therapy Allows comparisons between single drug therapies and combination of two drugs combined	Factorial design
allows patients to receive more than one drug treatment or dosage level during the course of the trial Assumption: drug therapy does not have a carry-over effect between the different tx period.	Crossover design:
placebo or no medication Depends on DOA or rate of elimination of trial drugs Issue: sufficient to eliminate carry-over effect During this period- trial data and clinical measures are collected to assess the impact of previous tx Considered as baseline data for subsequent tx Efficient in regards to no. of patients required to collect a data	"Washout period"
POSTMARKETING SURVEILLANCE (PHASE IV) drug therapy is not assigned by the researcher	Case-control and Cohort
CONTROLLING FOR BIAS critical component of the trial	Control of the intervention
Cause and effect of the relationship between the drug therapy and clinical outcomes can be established Accomplished through randomization- computer programs or number lists→ assures that assignment to tx intervention are unbiased In most trials, patients have equal chance of receiving each tx	ASSIGNMENT OF THE INTERVENTION
used to adjust for POTENTIAL DIFFERENCES IN RESPONSE between specific patient groups or trial sites. This assures an equal number of patients with this characteristics are assigned to each trial treatment.	STRATIFIED RANDOMIZATION
SAMPLE SIZE FOR A SPECIFIC NUMBER OF PATIENTS IS ESTABLISHED so that equal number of patients are assigned to each treatment group. It AVOIDS IMBALANCE IN ENROLLMENT between treatment groups as trial progresses.	BLOCKED RANDOMIZATION
used to control the application of intervention	Clinical protocols