A couple of weeks ago in our practice question of the week, we discussed Evidence Based Medicine (EBM). In this week’s post we’ll be discussing a question along the same lines as EBM– clinical research. In particular we’ll be reviewing the phases of clinical research.
To review, Clinical Research determines the safety and effectiveness of pharmaceuticals, medical devices, treatments, and diagnostic products intended for human use. Data and evidence collected from this research is then used to establish treatment options. So now that we’ve jogged your memory a little, let’s get into this week’s practice question for the clinical informatics exam.
Question
Q: Which phase of clinical research tests for dose ranging on human participants?
A. Phase 0
B. Phase 1
C. Phase II
D. Phase III
Explanation and Answer
The following table explains the various phases of clinical research. As the phases progress, the levels of human involvement increase. Doses and human also vary depending on the phase of clinical research.
|
Phase |
Goal |
Dose |
Participants |
Lead By |
Comments |
|
Pre- clinical |
Efficacy, toxicity, and pharmaco- kinetic information gathering |
unrestricted |
Non-human participants |
Graduate Researcher |
|
|
0 |
Pharmacokineti c and pharmaco- dynamic information gathering |
subtherapeutic |
10 human participants |
Clinical Researcher |
Phase 0 is interested in collecting data on oral bioavailability and drug half-life |
|
I |
Dose-ranging |
subtherapeutic |
20-100 human participants |
Clinical Researcher |
Phase I checks to make sure it is safe to move to efficacy testing (Phase II) |
|
II |
Test to see if there is any possible efficacy. Test for safety. |
therapeutic |
100-300 human participants |
Clinical Researcher |
Assumes the drug has no therapeutic effect |
|
III |
Test for efficacy and safety |
therapeutic |
1000-2000 human participants |
Clinical Researcher and Physician |
Assumes the drug has some therapeutic effect |
|
IV |
Drug in Use – Surveying long- term effects |
therapeutic |
Available for treatment of patients by physicians |
Physician |
Monitoring long-term use once drug is released |
|
V |
Translational Research |
n/a |
n/a |
n/a |
Collection and analysis of data. Integration into public health practice. |
As you can see, phase two consists of dose ranging on around 20 to 100 human participants. The phase is conducted by a clinical research and ensures that the treatment is safe prior to moving to efficacy testing in phase II.
Therefore, the best answer to this question is B: Phase I.
It’s a good idea to get to know the phases of clinical research for the clinical informatics exam as it will likely be on the exam. It’s also a vital part in understanding and critically analyzing literature.
If you’re looking for other study resources, check out some of our other practice questions of the week. You can also purchase our text – Clinical Informatics Board Review: Pass the Exam the First Time. It’s the only board review book for the clinical informatics exam and will save you a whole lot of time scouring the internet on the information you need to pass the exam. It also comes with a money back guarantee if you don’t pass the exam on your first attempt.
References:
For additional reading on this subject, check out the following resources:
US NIH Website
MD Anderson. What are the Phases of Clinical Trials?