Which of the following occurs during Phase III of the Clinical Trial Process:

Question

BlackTom AI · Accepted Answer

When evaluating what happens in Phase III of the Clinical Trial Process, it’s helpful to map each option to the typical goals of Phase III trials as understood in clinical research.
Option a: 'Assess dosing requirements' — This is generally associated with early-phase work, particularly Phase I (safety and dosing) and Phase II (preliminary efficacy and further dosing exploration). Phase III focuses more on comparing the new treatment to standard care and confirming efficacy at established dosing, rather than determining dosing from scratch. Therefore, this statement does not accurately describe Phase III.
Option b: 'Evaluate the long-term effects of new drugs' — Phase III trials do collect more data on safety and adverse events, sometimes over longer periods, but the primary emphasis is on confirming efficacy and comparing to standard treatment. Long-term effect evaluation is more strongly linked with Phase IV (post-marketing surveillance) or extended follow-up within Phase III depending on the trial, but as a standalone statement it overstates Phase III’s sole purpose. Hence this option is not a typical core characterization of Phase III.
Option c: 'Apply for FDA approval' — The submission for regulatory approval (e.g., NDA/BIo) occurs after Phase III data have been collected and analyzed, not during Phase III itself. Therefore this step is outside Phase III and occurs later in the process, making this option incorrect for Phase III.
Option d: 'Doctors compare the treatment with the standard care for that disease' — This accurately reflects Phase III’s central aim: to compare the new intervention against the current standard of care in a larger, diverse patient population to establish relative efficacy and safety. This comparison to standard treatment is a hallmark of Phase III trials and is why they are often randomized and multicenter. Therefore, this option correctly describes Phase III.
In summary, the reasoning above shows that options a, b, and c describe activities associated with other stages of drug development, while option d aligns with the core objective of Phase III trials.

Which of the following occurs during Phase III of the Clinical Trial Process:

View Explanation

Log in for full answers

Similar Questions

Which of the following are reasons Borgerson gives for thinking that the effectiveness of alternative medicine will not necessarily be demonstrated in large-scale, randomized controlled trials? (Check BOTH that apply)

Which of the following steps comes immediately before Phase I clinical testing?

In Phase III of the Clinical Trial Process, Doctors compare the treatment with the standard of care for that disease. They do so by gathering data from how many patients?

At what phase of clinical trials is a drug primarily tested for efficacy in patients who have the disease?

True or False: A single-arm trial includes multiple groups that are randomly assigned to different treatments.

Which of the following best describes Phase 3 of FDA clinical trials?

Which phase of the clinical trial process involves a sample of 100-200 patients to confirm the benefits and safety of a treatment?

Which phase of a clinical trial lasts several months and studies drug interactions with the body?

More Practical Tools for Students Powered by AI Study Helper

Homework AI Solver

Stylized AI Paper Writer

Plagiarism Checker Assistant

Citation AI Academic Writing Tool

In-Class Translation Assistant

AI Note Generator

AI Quiz Answers

Past Exam Questions from University Test Bank

Smart Practice Assistant

Adaptive Practice

Making Your Study Simpler