Chapter 11 - Clinical Trials Flashcards
The average number of trials per new drug has continued to increase, while patient recruitment has become even more challenging. True or false?
True.
What are the 7 ethical requirements for clinical trials?
Social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, independent review board/independent ethics committee, and respect for human subjects.
Phase I is the first experiment in which a drug is tested on the human body. True or false?
True.
Phase I
Assess the safety of the new drug.
Phase II
Determine the effective dose and the dosing regimen of frequency and duration.
Phase III
(pivotal trial) Determines the effectiveness of the drug - dosage, treatment frequency, duration, and target patient groups.
Phase IV
Post marketing approval trials to monitor the efficacy and side effects of the drug in an uncontrolled real-life situation.
Investigator
Conducts the study. Normally an expert in the field of the disease being investigated.
Protocol
Sets out how the trial is to be conducted.
Inclusion and Exclusion Criteria
Set out the conditions under which a person may or may not be included in the trial.
Surrogate markers
Used when it is not possible to measure the direct effect of the drug. Blood pressure, cholesterol, concentration of certain enymes, proteins, blood glucose levels, etc.
What are the three main areas of biostatistics?
Clinical statistics, epidemiology, and bioinformatics.
Mean
Sum of observed values divided by the number of observations.
Standard Error of the Mean
Describes the variability of the population mean that is measured in several different samples.
Incidence
The number of new events that occur during a specified period of time in a population at risk for developing the events.
Validity
The extent to which a test or surrogate is measuring what we think it’s measuring.
Sensitivity
Ability of the test to correctly identify those who have the disease.
Specificity
Ability of the test to identify correctly those who do not have the disease.
Predictive values
Help assess how useful a test will be in the clinical setting at the individual patient level. Depend on the prevalence of a disease in a population.
Kaplan-Meier analysis and Cox proportional hazards analysis
Two methods of survival analysis that account for inter-subject variation in events and follow up time.
Abstract
Road map for the clinical paper.
Introduction
Implicitly or explicitly identifies the clinical need that prompted the study.
Methods
Provides all the salient details of how the study was designed and conducted.
What is an example of prioritization of clinical information?
STEPS approach - Safety, tolerability, efficacy, price, and simplicity.
