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02: ClinTrials -ClinOps [clear filter]
Tuesday, June 14
 

10:00am CDT

21A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved in Clinical Trials
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-22-502-L04-P ; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events

Statistical methods are a powerful tool used in clinical trials to assess whether the data support evidence of a treatment effect. It is therefore key that the results of any statistical analysis are interpreted correctly. However, understanding and interpreting statistical results can be challenging for non-statisticians. In this workshop, participants will be introduced to common statistical methods applied to specific outcomes and their results. Some examples of potential statistical concepts to be covered can include commonly seen hypothesis test, survival analyses, regression modelling, MMRM, and adjusting for multiplicity. Important concepts such as p-values will be explained fully. Idealized examples as well as examples from publicly posted FDA reviews and results on clinicaltrials.gov will be used.

Group discussions using example outputs (including examples from FDA reviews) will give participants the opportunity to apply their learning by critically evaluating statistical analysis approaches and interpreting statistical results, thus giving participants the tools necessary to effectively communicate with their colleagues involved in drug development.


Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Registration info: Rate: $350
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.Upon completion of registration, participants will gain access to the following:
  • Live Event Access
  • Presentation Slides


Return to DIA 2022

Who should attend?

This course would be of interest to those working in clinical trials with a non-statistical background who would like to gain a high-level understanding of statistical analyses and interpretation so they can communicate with their statistical colleagues more effectively.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Discuss why certain statistical analyses are applied to specific outcomes
  • Assess statistical summaries and extract the important information
  • Evaluate the statistical results using easily understandable language



Moderators
avatar for Stephen Corson

Stephen Corson

Associate Director, Statistics and Technical Solutions, Phastar
I am a Statistician working at Phastar, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services to pharmaceutical and biotech companies. Prior to this I spent 3 years working as a Consultant Statistician in the Department of Mathematics... Read More →

Tuesday June 14, 2022 10:00am - 1:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
 
Thursday, June 16
 

2:00pm CDT

42P: Become a DCT Master: Understanding the Lifecycle of Decentralized Clinical Trials
Component Type: Tutorial

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events.

With a growing industry trend to incorporate decentralizing solutions in trial design, what does it really mean to run a Decentralized Clinical Trial and how is it any different than running traditional clinical trials? What new technologies are needed, and do these technological advancements require new processes and organizational structure changes? In this short course, you will learn some of the foundational elements of designing decentralized clinical trials/ hybrid trials, and how these advancements in trial design impact all of the stakeholders involved including the patient, sponsor, and site. At the end of the course, you will become Medidata certified in Mastering DCTs.

Registration info: Rate: $350
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.Upon completion of registration, participants will gain access to the following:
  • Live Event Access
  • Presentation Slides



Download Registration Form
Registration Questions? Send Email
1.888.257.6457

Return to DIA 2021 

Who should attend?

Head of ClinOps, Head of Innovation, Head of Patient Engagement and Recruitment

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Distinguish what defines decentralized clinical trials/hybrid trials and the foundational elements
  • Describe how decentralized clinical trials/hybrid trials operate at the patient and site levels and how to optimize the experience for patients, sponsors, and sites
  • Identify regulatory and privacy considerations when considering decentralizing solutions



Speakers
avatar for Brian Barnes

Brian Barnes

Director, Risk Management Strategy, Global Clinical Development Operations, BioNTech, United States
Brian has 17 years in clinical development and has specifically supported RBQM for ten years specializing in operational solutions for small to large pharma, biopharma, and biotech companies. Brian is a co-liaison within the Association of Clinical Research Organizations (ACRO) RBQM... Read More →
AH

Aryana Hosseinkhani

Senior Director Product Marketing, Patient Cloud, Medidata, a Dassault Systèmes company, United States
Aryana Hosseinkhani is the Senior Director of Product Marketing in Patient Cloud at Medidata, a Dassault Systemes Company. She completed her education at the University of California, Davis in Genetics and shortly after began working as a bench scientist in stem cell research. Aryana... Read More →
HR

Holly Robertson

Senior Director, Advisory & Enablement Services, Medidata, a Dassault Systèmes company, United States
Holly Robertson is the Sr. Director of Advisory & Enablement Services within the Patient Cloud team at Medidata Solutions, with over 20 years of experience in pre-clinical and clinical research. Dr. Robertson obtained her PhD in Pharmacology from the University of Colorado Health... Read More →
avatar for Michael Tucker

Michael Tucker

Medidata, a Dassault Systèmes Company, United States
Michael is a member of Medidata’s Mobile Health team and is a subject matter expert in electronic informed consent and virtual trials. Over the last six years, Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world... Read More →


Thursday June 16, 2022 2:00pm - 5:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
 

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