Clinical Practice Guidelines in Disease Management
This module begins with a general overview of clinical practice guidelines, and then describes how they are developed and implemented. Case study examples show how clinical practice guidelines are being implemented in healthcare organizations.
Effective Evidence-Based Medicine Oriented Sales Calls
This module examines how evidence-based medicine (EBM) can be woven into the following segments of a call: Opening; Demonstrating value; Managing issues, concerns, and objections; Closing; Following up.
Ethical Issues Related to Drug Safety Monitoring, Pricing, and Off-Label Promotion
Life science companies have ethical responsibilities beyond compliant advertising and promotional activities. Increasingly, manufacturers are being held accountable for the safety of their products once they have entered the marketplace. In addition to reporting issues associated with their products, companies may be required by the FDA to take additional risk mitigation steps. Companies doing business with certain federal programs must comply with pricing rules, but they must also consider the broader ethical implications of the prices they charge for their products, weighing public good against the needs of the organization and future product development. Sales professionals must also be familiar with their companies' policies on the issue of off-label promotion - what they can and cannot do when a prescriber asks about using a medicine for an indication not specifically approved by regulatory authorities. This module examines regulatory and industry response to these issues.
Evaluating the Importance and Clinical Relevance of Study Results
This module examines three questions that pertain to the real value and implications of a trial: What is the magnitude of the treatment effect?; What is the precision of the treatment effect? Was the sample size large enough to achieve adequate statistical power?
Evidence Based Medicine as a Sales Strategy
This module looks at EBM as a sales strategy, considers the regulatory implications, and outlines an approach to planning an EBM sales call.
Factors that Affect the Validity of Trial Results
This module helps you answer several relevant questions: Were patients randomly assigned to the different study groups?; Were all patients accounted for at the conclusion of the study?; Were the patients, clinicians, and study trial personnel blinded to the condition(s) to which patients were enrolled?; Were characteristics of the groups similar at baseline?; Were the groups treated equally, except for the investigational intervention?; Can the diagnostic tests used be validated against a gold standard?
Health-Related Quality of Life (HRQOL) Measures
This module describes the components of HRQOL measures and the use of instruments for measuring general health status, as well as disease-specific instruments. The module concludes with examples of how HRQOL data are being gathered and applied within healthcare organizations.
History and Definition of Evidence-Based Medicine
This module describes the historical background of EBM and defines the term as it is used today. It also describes the three main components of EBM and how they can be integrated with a patient-centric approach to care.
Opportunities Behind the Clinician’s Evidence-Based Medicine Challenge
This module looks at why clinicians often find it challenging to integrate evidence-based medicine (EBM) into clinical decision-making, and how their challenge can become your opportunity. Clinicians are more likely to be responsive to your product message if you become skilled at examining trial results from their viewpoint and providing evidence through study reprints and other support materials.
Postmarketing Drug Research
This module looks at the types of research that occur typically as postmarketing investigations, ie, when the drug is approved and in wide-scale clinical use. Such investigations include: Phase IV investigations (postmarketing surveillance); Comparative effectiveness research (CER); Noninferiority studies.
This module discusses the makeup of a research protocol and introduces you to several important concepts related to study design.
Research Reports and the Role of Statistical Analysis
This module discusses the benefits that published literature brings to the healthcare community and helps you distinguish which publications are likely to be most credible. It also sets the stage for understanding the contents of a research report by explaining the role of statistics in establishing a significant difference and the types of errors that may occur in statistical analysis.
The Anatomy of a Clinical Reprint
This module discusses the six standard sections of a clinical reprint: Abstract, Introduction, Methods, Results, Discussion, References. Your familiarity with these sections will help you: Navigate as needed within your own clinical reprints; Link clinical reprints with issues of interest to clinicians; Respond to clinical questions with trial-based evidence; Bring new focus to your interactions with clinicians.
The Current Status of Evidence Based Medicine
This module considers the current status of EBM in the context of the challenges it aims to help clinicians face, and the shortcomings of traditional clinical decision-making support solutions.
The Medical Device Approval Process
This module describes the FDA's risk-based classification and controls system and premarket submission options that define each medical device's particular regulatory path to demonstrate safety and effectiveness.
Trial Design from a Clinical Perspective
This module looks at study design from a clinical perspective. It explains which types of studies apply most appropriately to various kinds of clinical inquiry and explores the comparative elements that are unique to therapeutic trials, making them especially valuable in EBM discussions.
Understanding the Evidence-Based Medicine Process
This module describes the steps that comprise the evidence-based medicine (EBM) process. A case example demonstrates how EBM can enhance clinical decision-making and improve patient outcomes.
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