27

Clinical Statistics for Non-Statisticians (Part 2 of 2)

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Objectives:

This series will provide you with tools to critically process and analyze medical scientific literature. You will get a good understanding of basic statistical concepts and theory that enable you to explain, understand and interpret data. These Webinars are practical and based on published articles and the analysis of these. You will work with the theory in practice to increase your understanding of the strengths and weaknesses of the statistics in scientific literature.

Statistical analysis in clinical trials

– Null/alternative hypotheses

– Statistical assumptions (type I error, significance level, type II error, statistical power,)

– Hypothesis testing

– Statistical tests

Statistics used in RCTs

– Type of outcome measures (dichotomous, continuous, time-to-event)

– Statistics used for analysis of dichotomous data (relative risk, odds ratio, risk difference, NNT)

– Analysis of time-to-event variables (plotting and interpretation of Kaplan-Meier curves)

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25

A Global Perspective on Conducting Early Access Programs

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Objectives:

Early Access includes a variety of programs by which pharmaceutical companies make investigational therapies available to patients with life-threatening diseases. These patients have either exhausted available treatments or have no approved options. This presentation will review the processes and procedures to consider in the implementation of an Early Access Program and explore the opportunities and challenges posed therein.

At the end of this webinar the participant will be able to:

  • • List the differences between an early access program and a clinical trial
  • • Compare the different types of early access programs
  • • Describe the components needed to implement an early access program
  • • Understand how local laws and regulations govern the conduct of an early access program
  • • Understand the benefits and drawbacks of conducting an early access program

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28

Patient Engagement in Drug Development: An Opportunity for Medical Affairs

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Objectives:

At the conclusion of this eCademy Webinar, participants will be better able to understand:

  • • The numerous ways in which partnership with patients can impact the development and commercialization of medicines
  • • The current “patient centric” landscape in pharmaceutical drug development, including the patient perspective of clinical trial conduct, recent findings related to the value of patient-centric trial design, and innovative approaches to engaging with patients across the study continuum
  • • Key considerations for patient engagement in clinical trials

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33

Dust Off Your Scientific Communication Platforms: Updating, Implementing, and Operationalizing Them for Success

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Objectives:

The Scientific Communication Platform (SCP) is the foundation of a strong medical communications strategy for a pharmaceutical product or device, and serves as an important tool to align communications and messaging across functional areas. Even minor discrepancies in cited data and/or the way that data are described can lead to confusion and weaken a product’s overall value proposition. The SCP is based on scientific evidence and requires an in-depth analysis and review of available and anticipated data, the disease and competitive landscape, stakeholder perceptions, and aspirations about the product profile. Since the final SCP output ensures accurate and consistent language and referencing through all communication activities, putting a plan in place to ensure successful cross-functional and regional implementation and utilization of this valuable resource is critical.

After completing this Webinar, participants will be better able to:

  • • Ensure understanding of the basic components and processes involved in the development of a scientific communication platform (SCP)
  • • Understand how to develop and/or update an SCP so that the scientific and value narratives are integrated
  • • Learn how to train and implement an SCP across functional teams
  • • Glean insights into tailoring a global SCP to a regional SCP
  • • Understand the challenges of metricizing an SCP and practical solutions for measuring effectiveness

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26

Clinical Statistics for Non-Statisticians (Part 1 of 2)

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Objectives:

This series will provide you with tools to critically process and analyze medical scientific literature. You will get a good understanding of basic statistical concepts and theory that enable you to explain, understand and interpret data. These Webinars are practical and based on published articles and the analysis of these. You will work with the theory in practice to increase your understanding of the strengths and weaknesses of the statistics in scientific literature.

  • • To define some terminologies in statistics
  • • To explain different types of data (quantitative vs. qualitative)
  • • To describe different ways in presenting summary data (such as proportions, means, medians, range and standard deviation)
  • • To explain 95% confidence intervals
  • • Bivariate analyses and appropriate statistical testing for quantitative and qualitative variables

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65

Value Assessment for Health Technologies – A Primer on Cost-Effectiveness Analysis and Health Technology Assessment

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Objectives:

Health technology and value assessment can be conducted using a variety of methods. Dr. Malone will provide an overview of those methods and an introduction on how to interpret the results from cost-effectiveness studies. This webinar will also discuss issues with defining value for health technologies, especially pharmaceuticals.

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60

Medical Affairs Excellence and Ethics & Compliance in the Evolving Healthcare Landscape – Collaborating and Leading by Example

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Objectives:

By participating in this Webinar, attendees will be able to understand the importance of E&C in Medical Affairs and the amount of topics that this can cover

  • • The role of Medical Affairs in guiding ethical decisions internally and externally
  • • The impact of Medical Affairs beyond its remit
  • • Importance of sharing best practices for the role of Medical Affairs in strategic brand planning, and the ethics and compliance considerations for Medical Affairs plans
  • • And many other hot topics such as pro-active and reactive scientific exchange

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42

Compliance Considerations in Medical/Commercial Collaborations

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Objectives:

In this webinar, we explore two scenarios that can open Medical Affairs up to censure. Scenario one explores participation of commercial team members in Medical Advisory Boards and scenario two looks at the implications of a commercial team member requesting a medical team member to participate in a thought leader meeting.

By participating in this eCademy Webinar, attendees will be better able to:

  • • Deep dive into regulatory and other guidance on medical/commercial collaborations
  • • Explore latest updates to laws/regulations governing compliance
  • • Learn best practices & key considerations when conducting Medical Advisory Boards
  • • Explore common compliance risks and approaches to mitigate risk and safeguard credibility in scientific exchange

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43

Digital Opinion Leaders: A Challenging Role in a Changing Environment

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Objectives:

After attending this eCademy Webinar, participants will be better able to:

  • • Harmonize understanding of who a DOL is and the milestones to be considered in the implementation of a DOL initiative
  • • Build a well-defined road map to implement a DOL engagement initiative at a local level

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