Research and Development

Research & Development

Understanding the product development and approval processes will help your sales teams engage in a product dialogue about how this high-risk industry can improve patient care and transform lives.

Advances and Innovations in Medications

This module describes the role of medications, particularly new drugs, in saving and extending patients' lives, as well as improving their quality of life.

Essential Elements of Clinical Trials

This module provides a brief introduction to the general types of clinical trials, trial protocols, trial endpoints, the underlying principles that govern trials, and the patient enrollment process. These are all important topics in the context of meeting with clinicians to discuss or compare the evidence that supports a specific therapy in patient management.

Ethical Dimensions of Research Decisions

This module discusses the ethical issues that underlie practical research decisions, as well as the Statements of Principle and Good Clinical Practice (GCP) documents that aim to help guide such ethical choices.

Ethical Responsibilities when Conducting Clinical Trials

This module discusses ethical issues that are of importance during and subsequent to the conduct of a clinical trial.

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?

Experimental Designs

This module describes the most common experimental designs, including prospective and retrospective studies, cohort studies, case-control studies, and randomized-controlled trials (RCTs). The module also distinguishes systematic reviews from meta-analyses and looks at the relationship between research design and the level of evidence.

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?

Methods of Controlling Bias in Clinical Trials

This module explores how control groups, placebos, and blinding help to minimize bias.

Overview of Pharmaceutical Drug Patents

This module describes pharmaceutical drug patents and discusses the impact of patent expiration on the sales and price of a drug.

Sources of R and D Funding

This module looks at where the funding comes from and distinguishes grants from contracts.

The Costs and Financiers of Drug Development

This module focuses on the factors that contribute to the high cost of drug development, why the process takes so long, and the entities that fund the costs.

The Drug Development Process

This module provides an overview of the process involved in taking a new drug from the laboratory to clinicians' offices.

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.

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