Part 3: Rare Disease Clinical Development – Strategies for Ensuring Endpoint Integrity

Life Sciences, Clinical Trials,
  • Tuesday, April 21, 2020 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

Because clinical trial endpoints for rare diseases are often not well defined, consistency of endpoint assessments across study sites and over time are critical to ensuring data integrity. Having a cohesive training strategy that includes conducting pre-study evaluation and training, as well as ongoing review of clinical evaluator (CE) performance and adherence to standardised procedures is an important contributor to success.

In this free webinar, Medpace partners with Michelle Eagle of ATOM International, a provider of CE training for clinical trials across the world, to discuss approaches and steps that can be taken to ensure quality and integrity. For example, neuromuscular studies incorporate training of clinical evaluators at investigator meetings, support video-recording of patient assessments at study visits to review for quality control and perform periodic refresher training throughout the course of a study.

Topics will include:

  • What does a comprehensive training program look like?
  • How natural history data can inform endpoint selection (real-word examples)
  • Rating assessment considerations and review (video QC and clinical assessment reliability)
  • The role of data management – cleaning and coding of data to create structured output for review and reliability

To register for the other parts in this webinar series, please click below:

Speakers

http://Michelle%20Eagle,%20ATOM%20INTERNATIONAL%20LIMITED

Michelle Eagle, Managing Director, ATOM INTERNATIONAL LIMITED

Michelle Eagle has been a physiotherapist for nearly 40 years and has specialised in neuromuscular disorders for 30 years. Her PhD investigated the impact of nocturnal ventilation in Duchenne Muscular Dystrophy (DMD). From 1990 to 2016, Michelle was the lead physiotherapist at the John Walton Centre for Neuromuscular Diseases in Newcastle. She has been involved in the development of outcome measures and standards of care for many years and currently is the managing director of ATOM International Limited, which is a company that specialises in consultancy, training and quality control for clinical trials in neuromuscular diseases.

Message Presenter
http://Chad%20Leslie,%20Medpace

Chad Leslie, Sr. Data Manager, Medpace

Chad Leslie is a Senior Data Manager with 12+ years of industry experience in data collection for drug development. Mr. Leslie specializes in EDC builds/endpoint data management of phase 1-3 oncology and rare disease studies. These studies include investigational products for Duchenne muscular dystrophy, Charcot-Marie-Tooth disease, Facioscapulohumeral Muscular Dystrophy, immunotherapy, targeted agents, viral vector, novel biologic agents, and radioactive agents. He holds an undergraduate degree in mathematics from the University of Cincinnati.

Message Presenter
http://Michelle%20Petersen,%20Medpace

Michelle Petersen, MS, Senior Director, Clinical Trial Management, Medpace

Michelle Petersen has 13 years’ experience in preclinical and clinical research which includes managing global studies in multiple phases of clinical development. She has managed multiple global rare/ultra-rare disease trials with a focus on neuromuscular and pediatric disorders. Ms. Petersen is a member of Medpace’s specialized Rare Disease Consortium and she is adept in developing strategies necessary to address the potential challenges of recruitment and logistical requirements for studies of this nature. Ms. Petersen holds a Master of Science degree in Physiology from the University of Cincinnati College of Medicine.

Message Presenter

Who Should Attend?

This webinar will appeal to VPs, directors, managers and department heads working within:

  • Clinical Affairs
  • Clinical Research
  • Clinical Pharmacology
  • Clinical Outsourcing
  • Project Management
  • Regulatory Affairs
  • Medical Affairs

What You Will Learn

Participants will learn about:

  • What a comprehensive training program looks like
  • How natural history data can inform endpoint selection (real-word examples)
  • Rating assessment considerations and review (video QC and clinical assessment reliability)
  • The role of data management – cleaning and coding of data to create structured output for review and reliability

Xtalks Partners

Medpace

Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 3,400 people across 37 countries.

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