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Clinical Trial Design: Working with a Statistician

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CE Credits Available for this Activity: 1

Program Overview: The purpose of this activity is to educate medical professionals on the role a statistician plays in clinical trial design.

Target Audience: The target audience includes all healthcare professionals such as physicians, nurses, pharmacists, and allied health professionals who would like to learn about the role a statistician plays in the design of a clinical trial.

Release and Expiration Dates
03/16/2024 – 03/16/2027

Objectives
Explain the role of a statistician in clinical study design of a trial.
Define basic statistical terms.
Interpret clinical study types and endpoints.
Identify important methods for statistical data analysis.

References
Merriam Webster’s Collegiate Dictionary
du Prel et al. (2010)
University of Arkansas for Medical Science Department of Biostatistics

Faculty Disclosure 
The following planners, speakers, moderators, peer reviewers, and/or panelists of this CE activity have financial relationships with ineligible companies to disclose:
Jessica Snowden, MD – Consultant: Pfizer

All financial relationships have been mitigated.

No other planners, speakers, and/or peer reviewers of this CME activity have relevant financial relation­ships with ineligible companies to disclose.

The compliance reviewer, Courtney Bryant, Sara Hale, or Brandie Jones, has no relevant financial relationships with ineligible companies to disclose.

Planners: Jessica Snowden, MD; Jeannette Lee, PhD; Lora Lawrence, RN; Catrice Banks-Johnson, MPA; DeAnn Hubberd, MA

Speaker(s): Song Ounpraseuth, PhD

Speaker(s) Bio
Dr. Ounpraseuth is a Professor in the Department of Biostatistics of the Fay W. Boozman College of Public Health at the University of Arkansas for Medical Sciences (UAMS).  He is a Principal Investigator of the DCOC overseeing the statistical design, sample size estimation, and analytic plans for all ECHO ISPCTN clinical trials.  He interfaces directly with the NIH ECHO Program Office, the Data Safety and Monitoring Board (DSMB), and the Protocol Review Committee (PRC).  Currently, Dr. Ounpraseuth serves as the primary statistician on multiple ECHO ISPCTN protocols and participates in various writing groups.  He provides statistical support to researchers within the Network and participates in the NIH/DCOC/DCRI leadership meetings.  In addition to the activities of the ISPCTN, Dr. Ounpraseuth serves on various scientific review panels including DoD, PCORI, and NIH.  He currently serves as the primary statistical reviewer for the Journal of Ultrasound in Medicine and is an Associate Editor for BMC Health Services Research.

Instructions to Obtain Credit
(1) Launch the activity
(2) View the entire module online
(3) Complete the post-test
(must pass the post-test with a score of 80% to receive credit)
You may retake the post-test if you do not receive a passing score.
(4) Complete Evaluation and Print certificate

Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the University of Arkansas for Medical Sciences. University of Arkansas for Medical Sciences 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.

Credit Designation Statements
AMA Credit Designation Statement
The University of Arkansas for Medical Sciences designates this enduring material activity for a maximum of 1 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
ACPE Credit Designation Statement
These knowledge-based activities will provide pharmacists with up to 1.0 contact hour or 1 CEU. CE credit information, based on participation and completion of the program evaluation, will be provided to NABP within 60 days after the activity completion.
ANCC Credit Designation Statement
The University of Arkansas for Medical Sciences designates this enduring material activity for a maximum of 1 ANCC contact hours. Nursing contact hours will be awarded for successful completion of program components based upon documented attendance and completion of evaluation materials.
AAPA Credit Designation Statement
The University of Arkansas for Medical Sciences has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1 AAPA Category 1 CME credits. PAs should only claim credit commensurate with the extent of their participation.

Disclosure Policy Statement
It is the policy of the University of Arkansas for Medical Sciences (UAMS), Office of Continuing Education (OCE) to ensure balance, independence, objectivity, and scientific rigor in all directly or jointly provided educational activities. All individuals who are in a position to control the content of the educational activity (course/activity directors, planning committee members, staff, teachers, or authors of CE) must disclose all relevant financial relationships they have with any commercial interest(s) as well as the nature of the relationship. The ACCME describes relevant financial relationships as those in any amount occurring within the past 24 months that create a conflict of interest. Individuals who refuse to disclose will be disqualified from participation in the development, management, presentation, or evaluation of the CE activity.

UAMS Office of Continuing Education (OCE) Contact Information
4301 W Markham Street #525
Little Rock, AR 72205
Email: cmeconf@uams.edu
Phone: 501-661-7962 Fax: 501-661-7968

DCOC Contact Information
Catrice Banks-Johnson
Email: crbanksjohnson@uams.edu

DeAnn Hubberd
Email: DEHubberd@uams.edu

You can download an official transcript from your CloudCME profile (https://uams.cloud-cme.com/default.aspx) or you can request a copy of your transcript at https://ce.uams.edu/transcript-request-2/.

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