• Session Overview
• Program Content
• Faculty
• Target Audience and Learning Objectives
• Continuing Pharmacy Education Credit
• Specialty Recertification Credit
• Technical Requirements
• Fees
• Financial Support

Session Overview

The Fundamentals of Biostatistics and Clinical Trial Design workshop is recorded from the popular live workshop presented at Updates in Therapeutics^® 2018. Presented by two of ACCP’s most dynamic and knowledgeable faculty, Drs. DeYoung and Segars, this workshop is ideal for clinical pharmacists who plan to sit for a Board of Pharmacy Specialties (BPS) exam, are interested in learning more about biostatistics and trial design, or wish to earn 5.0 hours of board specialty recertification credit in Ambulatory Care Pharmacy, Critical Care Pharmacy, Pediatric Pharmacy, or Pharmacotherapy.

Note: To earn recertification credit, participants must complete the web based posttest by August 15, 2018 and achieve a passing score on the test.

Program Content

The workshop is divided into two major sections: (1) an overview of descriptive versus interferential statistics, factors that influence errors and how to estimate sample size, and choosing the appropriate statistics test; and (2) observational and interventional study designs and methodologies, how to best interpret measures of association, and screenings in medicine.

Faculty

	G. Robert DeYoung, Pharm.D., BCPS Manager - Clinical Pharmacy Services Residency (PGY-1) Program Director Mercy Health Saint Mary's Campus Grand Rapids, Michigan
	Larry W. Segars, Pharm.D., DrPH, FCCP, FACE, BCPS Associate Dean - College of Biosciences Associate Professor of Pharmacology - College of Osteopathic Medicine Kansas City University of Medicine and Biosciences Kansas City, Missouri

Target Audience and Learning Objectives

Clinical pharmacists with an interest in statistics and trial design, clinical pharmacists who plan to sit for a BPS specialty exam, and clinical pharmacists wishing to earn recertification credit in Ambulatory Care Pharmacy, Critical Care Pharmacy, Pediatric Pharmacy, or Pharmacotherapy.

At the conclusion of the program, the participant should be able to:

1. Apply your knowledge of descriptive statistics to determine the most appropriate way to summarize the results of your clinical trial and interpret the results of others.
2. Compare factors that influence statistical decision errors and distinguish which are most important when determining the sample size required to achieve a predetermined study power.
3. Select the most appropriate statistical test based on the data collected and the clinical research methodology.
4. Differentiate and recognize the designs and structures of key studies utilized in medical and public health publications, including:
   1. Interventional Studies, including:
      • Phase 0-4 studies
      • Parallel vs. Cross-Over study designs
      • Simple vs. Factorial study designs
   2. Observational Studies, including:
      • Case-Control & Nested Case-Control studies
      • Cohort studies
      • Cross-Sectional studies
5. Define and interpret key study-related concepts and terms.
6. Define/Describe and calculate the most important epidemiological terms associated with healthcare and research, including:
   1. Incidence
   2. Prevalence
   3. Risk & Risk Ratio (a.k.a. Relative Risk)
   4. Odds & Odds Ratio
   5. Proper interpretation of RR/OR/HR’s & their 95% Confidence Intervals
7. Define/Describe and Calculate the key terms associated with healthcare screenings, including:
   1. True Positive (TP) & False Positive (FP)
   2. True Negative (TN) & False Negative (FN)
   3. Sensitivity & Specificity
   4. Positive Predictive Value (PPV/PV-P) & Negative Predictive Value (NPV/PV-N)
   5. Diagnostic Accuracy

Continuing Pharmacy Education Credit

The American College of Clinical Pharmacy is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

Fundamentals of Biostatistics and Clinical Trial Design Workshop
Activity No. 0217-0000-18-056-H04-P; 5.0 contact hours.
An Application-Based Activity

To earn continuing pharmacy education (CPE) credit, participants must successfully complete the online posttest by February 14, 2021. Participants must also have their NABP e-Profile ID and date of birth on file with ACCP. Credit will be uploaded to CPE Monitor within 2-3 days of successful completion of the posttest. Partial credit is not available for this activity.

Specialty Recertification Credit

This activity is available for BCACP, BCCCP, BCPPS, and BCPS recertification credit. Dual credit is available for this activity in any combination of the specialty certifications listed above. To be eligible for 5.0 CPE hours of recertification credit, participants must listen to all 5.0 contact hours of the recorded presentations and then successfully complete the online posttest by August 15, 2018. Partial credit is not available for this activity.

ACCP, as the official provider approved by BPS, will record and report recertification credit earned for this activity directly to BPS.

Technical Requirements

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Fees

Financial Support

No financial support from external sources was obtained for this workshop.