Practice Question of the Week: Clinical Research

practice question of the week

Clinical Research 

Question

Q: Which phase of clinical research tests for dose ranging on human participants?

Explanation and Answer

PhaseGoalDoseParticipantsLead ByComments

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 Websitehttps://clinicaltrials.gov/

MD Anderson. What are the Phases of Clinical Trials?

MDAnderson