SOURCE: Xtalks

Xtalks Webinars

February 20, 2015 07:05 ET

How to Avoid Breaking the Blind in Clinical Trials, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - February 20, 2015) - The live broadcast takes place on Wednesday, March 18, 2015 at 11:00am EDT (15:00 GMT). Featured speaker Susan Diehl, Project Manager at Fisher Clinical Services, will discuss risk mitigation strategies for clinical supply professionals and those in key functional adjacencies. She will provide information about protecting the blind when using new drug delivery technologies for biologics as well as traditional dosage forms.

The proliferation of drug delivery options makes it harder today to ensure active, placebo, and comparator products used in clinical trials look and feel the same. Yet proper blinding of clinical supplies, including pre-filled syringes, inhalers, and transdermal patches, has never been more important. With the rising costs and risks of clinical development, it's imperative to reduce bias by keeping treatment assignments concealed from certain clinical trial participants. In the worst case scenario, a discolored plunger rod or the incorrect label font on an inhaler could break this blind unintentionally, compromising clinical data and leading to study termination.

Though there are many ways to accidentally break the blind in a clinical trial there are few educational resources or publications available to prevent these troubling incidents(1). Most organizations involved in conducting clinical trials do provide basic training on this subject, including Annex 13 rules for deliberately breaking the blind in the event of a medical need(2). However, clinical supply managers are often forced to learn the hard way about the intricacies of blinding when someone or something inadvertently reveals who is receiving an experimental treatment.

The blinding strategies provided in this webinar will span the clinical supply management process from pharmaceutical development, through trial design and planning, quality control, distribution and clinical site communications. It will also touch on important organizational topics related to protecting the blind such as managing change, risk evaluation, and decision making.

Ensuring active, placebo, and comparator products are indistinguishable in a clinical trial is one of the most important yet undervalued responsibilities of clinical development professionals. A review of best practices in this area, tips for risk mitigation, and an update on techniques for blinding new packaging types will help these professionals contribute to the ultimate goal of delivering unbiased clinical data.

Key Learning Objectives

  • Develop methods for training others in clinical supply blinding techniques
  • Improve organizational approaches for integrating risk evaluation into decision making
  • Evaluate risk mitigation strategies based on real world examples

To learn more about this event visit: How to Avoid Breaking the Blind in Clinical Trials

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/sponsorship.ashx

References:
 1. The Blinding of Materials in Clinical Trials: Essential Processes for Ensuring the Integrity of Clinical Study Data by Sandra Cook, Steven Yoder, Christina Owings, Barbara Campbell, and Charles Gentile, Pharmaceutical Engineering, January/February 2014.
 2. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 13 Investigational Medicinal Products, 03 February 2010.

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