POSTPONED
A Paradigm Shift in Clinical Research and Education: The P-value Controversy and the End of Statistical Significance?

POSTPONED

Given guidance and recent reports related to the novel coronavirus disease (COVID-19), this event has been postponed.

We hope to reschedule the symposium for later this year. As soon as new details are available, we will share them here.

We apologize for any inconvenience.

What does the p-value controversy mean for clinical research?

The deep controversy surrounding the use and misuse of p-values and statistical significance is evident in the decision by the American Statistical Association to issue a policy statement on the matter in 2016. The statement marked the first occasion the Association has taken a position on a specific matter of statistical practice since its founding in 1839.

This Tufts CTSI symposium, co-sponsored by the Tufts Data Intensive Studies Center (DISC),  aims to inform clinician researchers and statisticians regarding the principles covered in the statement as well as the controversy over the proper use and interpretation of the p-value. Distinguished panelists will speak on use of p-values from their multiple perspectives to reflect the landscape of opinions and provide guidance for investigators and educators going forward. They include scientists, statisticians, epidemiologists, and statistical advisors to prominent journals and policy organizations, with expertise in statistics, genetics, communication, nutrition, obesity, cardiovascular disease, and drug approval.

Learning objectives:

  • Understand the rationale behind the ASA statement that “No single index [i.e., p-value] should substitute for scientific reasoning.
  • Discuss the role that p-values have had on reproducibility and replication and the proposed remedies.
  • Apply alternative remedies for dealing with uncertainty in clinical research and education.


Panelists

John P.A. Ioannidis, MD, DSC

C.F. Rehnborg Chair in Disease Prevention and Professor at Stanford University
Author of “Why Most Published Research Findings are False,” accessed more than three million times. His recent JAMA viewpoint is subtitled “Do Not Abandon Significance.” Dr. Ioannidis has published nearly 1,000 papers and is one of the 10 most-cited scientists worldwide.

David Allison, PhD

Dean and Provost of the Indiana University School of Public Health
Author of “A Tragedy of Errors: Mistakes in Peer-reviewed Papers are Easy to Find but Hard to Fix, Report” and committee member of the National Academies of Sciences, Engineering, and Medicine report, “Reproducibility and Replicability in Science.”

David Harrington, PhD

Professor of Biostatistics, Emeritus, Harvard T.H. Chan School of Public Health
Co-Author of the 2019 New England Journal of Medicine article, “New Guidelines for Statistical Reporting in the Journal.” Dr. Harrington is also the principal investigator of the Statistical Coordinating Center for the Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium and the project leader of the Biostatistics Core and Director of the Biostatistics Research Program in the Dana-Farber/Harvard Cancer Center (DF/HCC).

Allen Schirm, PhD

Recently retired from Mathematica Policy Research
Co-Author of the 2019 The American Statistician editorial, “Moving to a World Beyond ‘p<0.05’.” He and Dr. Ron Wasserstein recently discussed their recommendations on statistical inference at the United States Conference on Teaching Statistics.

 

Details

Tuesday, April 7
8:30-11:30AM
Jean Mayer Human Nutrition Research Center on Aging (HNRCA)
711 Washington Street, Boston, MA 02111

All are welcome to attend, especially:

  • Clinician researchers and investigators leading clinical trials.
  • Statisticians working with and educating clinical investigators.

Registration

Space is limited. Please register to attend.

 

About Tufts CTSI Events

Tufts CTSI’s Professional Education programs provide non-degree continuing education and training for clinical and translational research professionals from all Tufts CTSI partners and beyond.

Course enrollment priority is given to researchers from Tufts CTSI partner institutions. If your participation needs to be approved by your supervisor or a person responsible for your time release, you may provide their contact information when you register for the program.

This course is provided free of charge, and was supported by the National Center for Advancing Translational Sciences, National Institutes of health, Award Number UL1TR002544.  The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

 

Seminars & Workshops
Bias and Confounding in Clinical Research

After completing this lecture, you will be able to:

  • Define the major types of epidemiologic bias – confounding, selection bias, and information bias
  • Identify ways to prevent bias
  • Explain the differences between precision and validity
  • Discuss the framework for assessing valid statistical association using alternative explanations of chance, bias and confounding
  • Interpret p-values and confidence intervals to assess the role of chance
  • Distinguish between external validity (generalizability) and internal validity
  • Identify strategies to control for potential confounders.

Taught by: Jessica Paulus, ScD

Seminars & Workshops
Concepts of Hypothesis Testing

After completing this lecture, you will be able to:

  • Define hypothesis testing
  • Explain the differences between a null and alternative hypothesis
  • Describe the purpose of statistical testing
  • Describe the relationship between hypothesis testing and p-value
  • Interpret results of chi-square and t-test.

Taught by: Lori Lyn Price, MAS.

Seminars & Workshops
Developing a Study Protocol

After completing this lecture, you will be able to:

  • Define a research protocol
  • Explain the difference between a protocol and a proposal
  • List the steps in planning a study
  • Identify potential issues in implementing a protocol
  • Describe the aspects of subject safety in a study
  • Explain why subject confidentiality is key to a study.

Taught by: Tammy Scott, PhD.

Seminars & Workshops
Evaluating Scientific Journal Articles

View the slides for this seminar (PDF).

View the article that will be discussed during this seminar (PDF).

 

What makes a journal article successful?

Join us for Evaluating Scientific Journal Articles and learn the questions you should ask yourself, whether reviewing journal articles or writing your own. This interactive seminar will be presented by Lori Lyn Price, MAS, Statistician in the Biostatistics, Epidemiology, and Research Design (BERD) Center.

By the end of this seminar you will be able to:

  • List the questions you should ask yourself when evaluating a scientific journal article.
  • Identify the specific, testable hypothesis of the paper.
  • Identify what type of study design was used.
  • Evaluate whether the results of the study were affected by bias.
  • Explain why this study was important, what it added to the literature, or how it changed health practice.
  • Appraise the compatibility of the conclusions of the study with the study objectives.

Details

Thursday, April 28th, 2016 1:00 – 2:30PM
Tufts Center for Medical Education, Room 114
145 Harrison Avenue, Boston

Or via live, interactive webcast (a link will be provided to those who register).

 

Seminars & Workshops
Formulating Research Questions, Hypotheses and Objectives

After completing this lecture, you will be able to:

  • Outline approach to formulating structured, clinically-relevant research questions
  • Highlight importance of evidence based approach to critically evaluating scientific literature
  • Review existing tools and resources
  • Review relationship between types of clinical questions and study design
  • Explain the relationship between research questions and objectives, specific aims, hypotheses, power/sample size, and statistical analysis.

Taught by: Kahsi A. Smith, PhD.

Seminars & Workshops
How Many Subjects Do I Need for My Study?

After completing this lecture, you will be able to:

  • Explain the role of chance in sampling a population
  • State the steps in hypothesis testing
  • Identify types of statistical error
  • Describe what parameters affect sample size
  • List online resources for sample size calculators
  • Perform a basic sample size calculation using an online tool.

Taught by: Jessica K. Paulus, ScD.

Seminars & Workshops
Introduction to Study Design

After completing this lecture, you will be able to:

  • Explain the importance of looking at the totality of evidence in developing and assessing a research question
  • Define an experimental study design strategy
  • Define an observational design strategy
  • Identify the strengths and challenges of retrospective and prospective studies
  • State the limitations of observational studies
  • Express the differences between cohort and case-control studies
  • Describe what a randomized clinical trial is
  • Explain how to limit confounding bias
  • Describe the strengths and limitations in doing interventional studies.

Taught by: Jessica Paulus, ScD.

Seminars & Workshops
Linear and Logistic Regression

After completing this lecture, you will be able to:

  1. Determine when regression should be used
  2. Describe the differences between linear and logistic regression
  3. Discuss basic assumptions of linear and logistic regression
  4. Identify the advantages of regression models
  5. Interpret the results of regression models.

Taught by Lori Lyn Price, MAS

Seminars & Workshops
Modeling Time-to-Event Outcomes

After completing this lecture, you will be able to:

  • Define survival analysis
  • Explain how time-to-event data is different from other data
  • Discuss the differences between Kaplan-Meier curves and Cox regression
  • Identify a Kaplan-Meier curve and a Cox regression in a journal article
  • Describe how survival estimates are calculated

Taught by Robin Ruthazer, MPH,

Seminars & Workshops
Pitfalls in Statistical Analysis

After completing this lecture, you will be able to:

  • Discuss how statistical significance does not equal clinical significance
  • Describe common mistakes about null hypothesis testing
  • Explain the importance of matching your analysis to the study design
  • Determine three considerations for controlling for multiple testing
  • Explain how to handle missing data
  • Identify statistical considerations in an actual published study.

Taught by: Lori Lyn Price, MAS

Seminars & Workshops
Research Database Creation: Basics and Best Practices

Overview

Are you involved in building a database for your research project?

Building an appropriate database for your study is critical to ensuring successful data collection and analysis. Learn how to build a database in this 90-minute Tufts CTSI workshop, Research Database Creation: Basics & Best Practices. This session will begin with an interactive lecture presented by Rachael Huebner, a Clinical Data Manager at Tufts CTSI, followed by a workshop in which participants will practice building a simple database in Excel.

This workshop is a prerequisite to a subsequent workshop, Research Database Creation: Building a REDCap Database.

After attending this event, you should be able to:

  • Recognize database creation best practices
  • Identify the clinical and demographic data needed to answer a study question
  • Effectively name and code variables
  • Create an Excel sheet appropriate for study data collection

Details

Date: Tuesday, October 29, 1:00-2:30PM

Location: Tufts Medical Center, IS Training Room, Ziskind Building, 1st Floor, Room 114A

This workshop is a prerequisite to a subsequent workshop, Research Database Creation: Building a REDCap Database.

Registration

This workshop is designed for research assistants, clinical research coordinators, investigators, residents, and fellows who will be creating or working with databases for research projects.

The workshop is now full. To add your name to the waitlist, please register here.

Tufts CTSI Professional Education & Expectation for Course Participants

Tufts CTSI’s Professional Education programs provide non-degree continuing education and training for clinical and translational research professionals from all Tufts CTSI partners and beyond.

Course enrollment priority is given to researchers from Tufts CTSI partner institutions. If your participation needs to be approved by your supervisor or a person responsible for your time release, you may provide their contact information when you register for the program.

This course is provided free of charge, and was supported by the National Center for Advancing Translational Sciences, National Institutes of health, Award Number UL1TR002544. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

 

Seminars & Workshops
Research Database Creation: Basics and Best Practices 2020

Overview

Are you involved in building a database for your research project?

Building an appropriate database for your study is critical to ensuring successful data collection and analysis. Learn how to build a database in this 90-minute Tufts CTSI workshop, Research Database Creation: Basics & Best Practices. This session will begin with an interactive lecture presented by Rachael Huebner, a Clinical Data Manager at Tufts CTSI, followed by a workshop in which participants will practice building a simple database in Excel.

This workshop is a prerequisite to a subsequent workshop, Research Database Creation: Building a REDCap Database.  Please note, in this workshop, we will not be using REDCap, but we will be learning the fundamentals required for database creation, which will inform our second session where REDCap will be used.

After attending this event, you should be able to:

  • Recognize database creation best practices
  • Identify the clinical and demographic data needed to answer a study question
  • Effectively name and code variables
  • Create an Excel sheet appropriate for study data collection

Details

Date: Thursday, March 12, noon-1:30PM

Location: ONLINE ONLY

This workshop is a prerequisite to a subsequent workshop, Research Database Creation: Building a REDCap Database.

Registration

This workshop is designed for research assistants, clinical research coordinators, investigators, residents, and fellows who will be creating or working with databases for research projects.

To attend, please register here by March 5.

Tufts CTSI Professional Education & Expectation for Course Participants

Tufts CTSI’s Professional Education programs provide non-degree continuing education and training for clinical and translational research professionals from all Tufts CTSI partners and beyond.

Course enrollment priority is given to researchers from Tufts CTSI partner institutions. If your participation needs to be approved by your supervisor or a person responsible for your time release, you may provide their contact information when you register for the program.

This course is provided free of charge, and was supported by the National Center for Advancing Translational Sciences, National Institutes of health, Award Number UL1TR002544. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

 

Seminars & Workshops
Research Database Creation: Building a REDCap Database

Overview

Are you involved in building a REDCap database for your research project?

REDCap is an online application that can be used to create research databases. It has many advantages over Excel, and is often the preferred tool for database creation. Learn how to create REDCap databases for your research projects in this 90-minute Tufts CTSI workshop, Research Database Creation: Building a REDCap Database.

This session will begin with a lecture presented by Rachael Huebner, a Clinical Data Manager at Tufts CTSI, followed by a workshop in which participants will practice building a simple database in REDCap.

To attend this event, participants must attend the first workshop in this series, Research Database Creation: Basics & Best Practices.

After attending this event, you should be able to:

  • Describe the differences between classic and longitudinal projects, and identify when to use each
  • Create projects, forms, and fields in REDCap
  • Export data from REDCap to Excel

Details

Date: Tuesday, November 12, 2:00-3:30PM

Location: Tufts Medical Center, IS Training Room, Ziskind Building, 1st Floor, Room 114A

To attend this event, participants must attend the first workshop in this series, Research Database Creation: Basics & Best Practices.

Registration

This workshop is designed for research assistants, clinical research coordinators, investigators, residents, and fellows who will be creating or working with databases for research projects.

Space is limited. To reserve your seat, please register here by October 24.

Tufts CTSI Professional Education & Expectation for Course Participants

Tufts CTSI’s Professional Education programs provide non-degree continuing education and training for clinical and translational research professionals from all Tufts CTSI partners and beyond.

Course enrollment priority is given to researchers from Tufts CTSI partner institutions. If your participation needs to be approved by your supervisor or a person responsible for your time release, you may provide their contact information when you register for the program.

This course is provided free of charge, and was supported by the National Center for Advancing Translational Sciences, National Institutes of health, Award Number UL1TR002544. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

 

Seminars & Workshops
Research Database Creation: Building a REDCap Database 2020

Overview

Are you involved in building a REDCap database for your research project?

REDCap is an online application that can be used to create research databases. It has many advantages over Excel, and is often the preferred tool for database creation. Learn how to create REDCap databases for your research projects in this 90-minute Tufts CTSI workshop, Research Database Creation: Building a REDCap Database.

This session will consist of a guided tutorial, led by Rachael Huebner, Clinical Data Manager at Tufts CTSI, in which participants will build a simple database in REDCap.

To attend this event, participants must attend the first workshop in this series, Research Database Creation: Basics & Best Practices.

After attending this event, you should be able to:

  • Describe the differences between classic and longitudinal projects, and identify when to use each
  • Create projects, forms, and fields in REDCap
  • Export data from REDCap to Excel

Details

Date: Thursday, March 26, noon-1:30PM

Location: Tufts Center for Medical Education, Room 514 (Computer Lab), 145 Harrison Avenue, Boston

To attend this event, participants must attend the first workshop in this series, Research Database Creation: Basics & Best Practices.

Registration

This workshop is designed for research assistants, clinical research coordinators, investigators, residents, and fellows who will be creating or working with databases for research projects.

Space is limited.

To reserve your seat, please register here by March 19.

Tufts CTSI Professional Education & Expectation for Course Participants

Tufts CTSI’s Professional Education programs provide non-degree continuing education and training for clinical and translational research professionals from all Tufts CTSI partners and beyond.

Course enrollment priority is given to researchers from Tufts CTSI partner institutions. If your participation needs to be approved by your supervisor or a person responsible for your time release, you may provide their contact information when you register for the program.

This course is provided free of charge, and was supported by the National Center for Advancing Translational Sciences, National Institutes of health, Award Number UL1TR002544. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.