Translational and Clinical Research

Question 1

DSMB

Answer 1

Data Safety and Monitoring Board (independent committee that reviews data during clinical trial to manage risk)

Question 2

Phase One Translation (T1)

Answer 2

Transfer of knowledge from lab to produce new drugs, devices, and treatment options

Question 3

Phase two translation (T2)

Answer 3

Assessment of value of T1 applications for health practice leading to evidence-based guidelines

Question 4

Phase three translation (T3)

Answer 4

Movement of evidence-based guidelines into health practice

Question 5

Phase four translation (T4)

Answer 5

Evaluation of real world health outcomes of a T1 application in practice

Question 6

FDAAA 801 (207)

Answer 6

Expanded clinical trial registry and added a result database

Question 7

Phase one clinical trials

Answer 7

Small sample of healthy volunteers for safety, PK, AEs

Question 8

Phase two clinical trials

Answer 8

Medium clinical sample for dosing, safety, efficacy, placebo effects

Question 9

Phase three clinical trials

Answer 9

Large clinical sample for efficacy, AEs, special populations

Question 10

Phase four clinical research

Answer 10

Postmarket surveillance looking for low incidence AEs, risk/benefit, and pharmacoeconomics

Question 11

Phase five clinical research

Answer 11

Mega trials, additional claims and/or new indicates

Question 12

Case control studies

Answer 12

Examines group of subjects who experienced an event (e.g. cancer) and those who have not (e.g. no cancer)

Question 13

In which can you calculate relative risk and in which can you only calculate an odds ratio: Cohor studies and Case Control studies

Answer 13

Case control - odds ratio only, Cohort - relative risk

Question 14

What act mandated informed consent in US clinical trials?

Answer 14

The Kefauver-Harris Amendment (Drug Efficacy Amendment of 1962)

Question 15

Reporting of adverse events has been required since when?

Answer 15

September 2009