The Critical Impact of Rater Training in Dermatology Clinical Trials

Life Sciences, Clinical Trials, Patient Recruitment & Retention, Drug Discovery & Development,
  • Tuesday, March 23, 2021

In clinical studies, accuracy and consistency are paramount. However, accurate rating – subjective data collected from stakeholders including patients, caregivers, observers, and clinicians – can be difficult to obtain. Since ensuring rating accuracy and consistency are critical, rater training is an important step that has been proven to reduce rater errors.

Fortunately, rating inconsistency can be improved with training. From in-field training to establishing minimum standards for training and minimum standards for demonstrating competence, raters must be fully consistent and familiar with the purpose of each scale, standardized rules for administration, overview of the scale items, and the scoring for each item as defined in the study’s protocols. Proper rater training ensures confidence in their results.

Please join Synteract’s Betsey Zbyszynski, Executive Director, Strategic Development, Dermatology, and Dr. Orin Goldblum, Senior Medical Director, Dermatology, joined by Eric Zudak, Vice President Stategic Partnerships, from WCG Trifecta, on Tuesday, March 23, at 11 am EDT as they explore this topic in our webinar, The Critical Impact of Rater Training in Dermatology Clinical Trials.

Speakers

http://Betsey%20Zbyszynski,%20Synteract

Betsey Zbyszynski, Executive Director, Strategic Development, Dermatology, Synteract

Betsey has been in the clinical research industry for over 25 years.  She began her career as a clinical research coordinator at an ophthalmic clinical research site.  Since then, Betsey has worked in the clinical monitoring, project management and business development sectors of the industry.  Betsey was the Clinical Research Manager solely responsible for managing the clinical trials that received FDA approval of the first human collagen product for dermal filler. 

For fifteen years, Betsey worked in the CRO setting.  She managed the growth of a start-up CRO division from $0 revenues to a $6 million revenue within its first year and was instrumental in the strategic partnership with a biometrics company.  She helped managed another small start-up CRO to over $25 million in annual revenue by generating new business as well as maintaining the business relationships.  Most recently, Betsey worked on the pharma side as Director of Outsourcing.  Her responsibilities included vendor management, RFPs and negotiating the clinical trial budgets and contracts. Her main therapeutic areas of expertise include dermatology, cosmetic dermatology and ophthalmology.

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http://Orin%20Goldblum,%20Synteract

Orin Goldblum, MD, Senior Medical Director, Medical Affairs, Dermatology, Synteract

Dr. Goldblum is a board-certified dermatologist with over 35 years of experience in clinical dermatology, medical affairs, and drug development. Prior to joining Synteract, Dr. Goldblum was a Medical Fellow in US Dermatology Medical Affairs at Eli Lilly and Company in Indianapolis, IN where he served as the senior scientific and clinical member of the US dermatology medical affairs leadership team.  Prior to that he was Medical Director at CRO, Novum Pharmaceutical Research Services in Pittsburgh, PA serving as Medical Monitor on several dermatology clinical trials. Prior to Novum, he was Medical Director in Immunology (Dermatology) Global Medical Affairs at Abbott Laboratories (now AbbVie) in Abbott Park, IL. Before working in the pharma/CRO industry, Dr. Goldblum practiced dermatology in Pittsburgh, PA, for over 20 years.

Dr. Goldblum received his undergraduate and medical school degrees from the University of Pittsburgh. He completed his medical internship at Mercy Hospital (now UPMC Mercy) in Pittsburgh, PA, and his dermatology residency at the Johns Hopkins Medical Institutions in Baltimore, MD. He previously served on the clinical faculty in the Department of Dermatology at the University of Pittsburgh School of Medicine. Dr. Goldblum has authored or co-authored over 60 scientific papers and over 100 scientific abstracts, posters, and presentations and is an active member of the American Academy of Dermatology.

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http://Eric%20Zudak,%20WCG%20Trifecta

Eric Zudak, Vice President Strategic Partnerships, WCG Trifecta

Eric Zudak has been with Trifecta Clinical since 2005.  Eric began in Operations supporting global Investigator training before moving into a consulting business development and led the enterprise implementation of Trifecta services for Trifecta’s largest account. Specializing in enterprise level adoption, Eric has worked with key accounts to ensure successful onboarding of one or more services across a client’s portfolio. As part of onboarding, Eric has consulted on numerous innovation projects specific to customer specific site start up process automation. In 2018, Eric initiated the “Trifecta Immunology Endpoint Services” initiative (TIES) focused on process improvement and unmet needs in Immuno-dermatology study workflow.

Prior to joining Trifecta Eric worked in the entertainment Industry, with Walt Disney Imagineering, ABC Television, and numerous freelance projects in professional theatre and independent film. Eric also founded the “College Town Film Festival” which produced 7 festivals over 4 (2013-2016) years at Penn State University in State College PA, and Ohio University in his hometown of Athens, Ohio. Eric holds a Bachelor of Fine Arts from the University of Evansville.

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Who Should Attend?

This webinar will appeal to VPs, Directors, Managers, Department Heads, Scientists and Researchers working in dermatology drug development:

  • Clinical Affairs
  • Clinical R&D
  • Clinical Research
  • Clinical Pharmacology
  • Clinical Operations
  • Project Management
  • Regulatory Affairs
  • Medical Affairs

What You Will Learn

In this webinar, participants will learn about:

  • The current dermatology clinical trial landscape, with examples of scales for rater training
  • The importance of rater training
  • Traditional versus virtual rater training
  • The impact of rater training on clinical outcomes
  • The components of an effective endpoint rater training strategy

Xtalks Partner

Synteract

With employees across 21 countries, Synteract is an innovative, full-service CRO supporting biopharma companies across all phases of drug development to help bring new medicines to market. Synteract has conducted 4,000 studies on six continents and in more than 60 countries, working with more than 26,000 investigative sites and 750,000 patients. Greater than 245 of its 4,000 studies have been in pediatric populations. In addition to pediatrics clinical trials, Synteract offers a notable depth of therapeutic expertise in dermatology, neurodegenerative, oncology and immunotherapy, and rare/orphan disease studies.

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