Drug Trials

Overview

4.6 out of 5 (29 Reviews)

Credits

1.50

Post-Assessment Questions

8

Start Date

1 Sep 2023

Last Review Date

13 Dec 2025

Expiration Date

31 Aug 2026

Estimated Time To Finish

90 Minutes


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Activity Description

Clinical drug trials constitute a cornerstone of medical science, systematically evaluating the safety and efficacy of medications in human subjects to advance evidence-based healthcare. These trials encompass the development of new drugs and the reevaluation of existing ones, addressing specific medical conditions through structured phases: preclinical testing, phase I (safety), phase II (efficacy and dosing), phase III (large-scale efficacy and safety), and phase IV (post-marketing surveillance). High-quality trials employ rigorous methods, including randomization, blinding, and statistically powered sample sizes, to minimize bias and ensure reliable results. Innovative designs, such as adaptive, cluster, and pragmatic trials, enhance flexibility and real-world applicability, while surrogate markers accelerate research but require cautious interpretation to ensure clinical relevance. Institutional Review Board oversight and ethical safeguards protect participants, ensuring trials adhere to regulatory standards. By generating robust evidence, clinical drug trials guide treatment decisions, improve therapeutic outcomes, and address unmet medical needs across diverse patient populations.

This educational activity enhances clinicians’ competence in understanding clinical drug trial design, execution, and interpretation, focusing on randomized controlled trials (RCTs) as the gold standard for establishing drug safety and efficacy. Participants learn to navigate trial phases, evaluate elements like randomization and blinding, and recognize the role of surrogate markers in accelerating research. The course emphasizes ethical considerations, including IRB oversight and participant protections, to ensure scientific integrity. Clinicians gain skills to critically assess trial evidence and apply findings to optimize patient care strategies. Interprofessional collaboration among clinicians, pharmacists, nurses, research associates, and data analysts enhances patient outcomes by integrating diverse expertise in trial interpretation, medication management, and monitoring for adverse effects. This team approach ensures accurate application of RCT evidence, reduces practice gaps in understanding trial methodologies, and improves treatment efficacy and safety across varied clinical settings.


Target Audience

This activity has been designed to meet the educational needs of physicians, physician associates, nurses, pharmacists, and nurse practitioners.

Learning Objectives

At the conclusion of this activity, the learner will be better able to:

  • Create strategies that integrate trial results into individualized care plans, considering patient comorbidities and treatment goals.

  • Differentiate between surrogate endpoints, biomarkers, and clinically relevant outcomes to avoid misinterpretation of trial findings.

  • Determine appropriate dosing, therapeutic regimens, and monitoring parameters by critically reviewing phase II and III trial data.

  • Collaborate with the interprofessional team to improve research outcomes and ensure transparency and appropriate application of information provided from drug trials.

Disclosures

StatPearls, LLC requires everyone who influences the content of an educational activity to disclose relevant financial relationships with ineligible companies that have occurred within the past 24 months. Ineligible companies are organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. All relevant conflict(s) of interest have been mitigated. Hover over contributor names for financial disclosures. Others involved in planning this educational activity have no relevant financial relationships to disclose.

Commercial Support: This activity has received NO commercial support.

Continuing Education Accreditation Information

In support of improving patient care, StatPearls, LLC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

 

Physicians and Physician Associates: StatPearls, LLC designates this enduring material for a maximum of 1.50 AMA PRA Category 1 Credit(s)TM. Physicians and PAs should only claim credit commensurate with the extent of their participation in the activity.

American Board of Anesthesiology: This activity contributes to the CME component of the American Board of Anesthesiology’s redesigned Maintenance of Certification in AnesthesiologyTM (MOCA®) program, known as MOCA 2.0®. Please consult the ABA website, www.theABA.org, for a list of all MOCA 2.0 requirements.

American Board of Internal Medicine: Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1.50 MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

American Board of Otolaryngology–Head and Neck Surgery: Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn their required annual part II self-assessment credit in the American Board of Otolaryngology–Head and Neck Surgery’s Continuing Certification program (formerly known as MOC). It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of recognizing participation.

American Board of Orthopaedic Surgery: Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn credit toward the CME and Self-Assessment Examination requirements of the American Board of Orthopaedic Surgery’s (ABOS) Maintenance of Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABOS credit.

American Board of Pathology: Successful completion of this Continuing Certification activity, which includes participation in the evaluation component, enables the participant to earn up to 1.50 Lifelong Learning (CME) credits in the American Board of Pathology’s Continuing Certification Program.

American Board of Pediatrics: Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn up to 1.50 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program. It is the CME activity provider’s responsibility to submit learner completion information to ACCME for the purpose of granting ABP MOC credit.

American Board of Surgery: Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABS credit.

American Board of Thoracic Surgery: Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn credit toward the CME and Self-Assessment in Practice requirements of the American Board of Thoracic Surgery’s Maintenance of Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABTS credit.

Royal College of Physicians and Surgeons of Canada: Through an agreement between the Accreditation Council for Continuing Medical Education and the Royal College of Physicians and Surgeons of Canada, medical practitioners participating in the Royal College MOC Program may record completion of accredited activities registered under the ACCME’s “CME in Support of MOC” program in Section 3 of the Royal College’s MOC Program.

Please consult your professional licensing board for information on the applicability and acceptance of continuing education credit for this activity.

Method of Participation and Credit

  1. Register for the activity.    
  2. Review the target audience, learning objectives, and disclosure information.
  3. Study the educational content of the enduring material.
  4. Choose the best answer to each activity test question. To receive credit and a certificate, you must pass the test questions with a minimum score of 100%.
  5. Complete the post-activity assessment survey.

If you have concerns regarding the CE/CME system, please contact support@statpearls.com.

Disclaimer

This educational activity was planned and produced in accordance with the ACCME Standards for Integrity and Independence in Accredited Continuing Education. Faculty may discuss investigational products or off-label uses of products regulated by the FDA. Readers should verify all information before employing any therapies described in this educational activity.

The information provided for this activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition. The information presented does not necessarily reflect the views of StatPearls or any commercial supporters of educational activities on statpearls.com. StatPearls expressly disclaims responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through a participant's misunderstanding of the content.

Unapproved Uses of Drugs/Devices: In accordance with FDA requirements, the audience is advised that information presented in this continuing education activity may contain references to unlabeled or unapproved uses of drugs or devices. Please refer to the FDA-approved package insert for each drug/device for full prescribing/utilization information.

Cancellation Policy: Please see the cancellation policy. StatPearls, LLC reserves the right to cancel any course due to unforeseen circumstances.

 

 
 

Reviews

karen h. on 6/26/2021

Alessandra T. on 6/26/2022

Yuliya N. on 7/30/2022

Amelia B. on 10/10/2022

wellington c. on 4/7/2023

Steven H. on 4/15/2023

Jana T. on 6/1/2023

Jennifer P. on 9/13/2023

Matthew C. on 9/12/2024

Doven Jae A. on 12/27/2023

Jacob H. on 3/19/2024

Lou Y. on 4/23/2024

Michelle J. on 5/11/2024

James N. on 5/12/2024

Lesly P. on 8/5/2024

Margaret F. on 9/15/2024

Stephanie C. on 11/7/2024

brittany l. on 11/16/2024

This is an excellent educational activity.

Nury C. on 6/9/2025

Amy L. on 7/21/2025

Lori L. on 10/27/2025

Bruce M. on 11/14/2025

cathy b. on 1/4/2026

Christine C. on 2/9/2026

ami k. on 2/21/2026

Samantha W. on 4/7/2026

Kylie H. on 4/21/2026

Heather R. on 6/1/2026

Jacob R. on 6/21/2026

Unlimited Physician CME

Stay up to date on the latest medical knowledge with 6344 CME activities. In these online self-assessment activities, read our reference articles and test your knowledge with more than 7563 hours of CME.

Learn About Lifetime CME

Single Activity

Take this single activity

$73.50 1 activity

6 Month Unlimited Physician CME

Access to all the Unlimited Physician CME activities in all specialties.

$399 per half year per user

1 Year Unlimited Physician CME

Access to all the Unlimited Physician CME activities in all specialties.

$649 per 1 year per user