Developing a Digital Protocol for Dermatology Trials: A Step-by-Step Guide to Optimizing Research for Patients and Clinicians

An important trend in the dermatology clinical space is the increasing use of technology for virtual visits, remote electronic consent, and other applications. With the COVID-19 pandemic as a driver for uptake, teledermatology has gained more widespread use across the world for clinical consultation, patient assessment and follow-up. Virtual visits are of increasing interest in dermatology clinical trials as a way of reducing the study visit burden for both patients and trial sites.

To be most successful, dermatology clinical trials should not only be digitally enabled, but accessible to a diverse array of qualified patients and designed to encourage patient participation. The digital options available today reduce patient and investigator site burden, accelerate start-up and enrollment timelines, and ensure consistent, high-quality assessments and data collection.

Speakers

Rose Blackburne, MD, MBA, Executive Medical Director, Global Product Development, PPD

Dr. Blackburne is a board-certified physician and experienced healthcare executive. As an industry leader, her career in healthcare spans over 25 years, including clinical practice, direct patient care, health management, and most recently as an executive in pharmaceutical, biotechnology, and medical device product development. Dr. Blackburne earned her medical degree from the Morehouse School of Medicine and an MBA from the University of Virginia Darden Graduate School of Business. Dr. Blackburne serves as Industry Representative Alternate (2016–2021) to the FDA Patient Engagement Advisory Committee (PEAC) to provide advice on issues relating to the regulation of medical devices and their use by patients and to develop agency guidance and policies.

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Norma Cantu, Senior Director, Project Management, PPD

Norma Cantu is a Sr. Director of Project Management within GenMed at PPD. She has more than 20 years of pharmaceutical research experience in various roles. She began her career in clinical site operations as a project manager. Cantu has worked across multiple functional areas supporting site management, clinical management, project management, regulatory affairs, medical writing, IVRS, data management, patient recruitment and IT. She was Program Operational Lead from 2016-2018, responsible for ensuring alignment between PPD and Sponsors across key segments of the business and assist in setting strategy for the partnership. In 2019, Cantu was selected as the Dermatology Indication Champion, responsible for supporting the dermatology project teams as needed with landscape analysis, recruitment strategies and data reliability and standardization.

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John Manns, Senior Director, Innovation and Digital Operations, PPD® Digital

In his current role, John Manns provides vision and strategy on planning and executing decentralized clinical trials to solve operational challenges, particularly where there is a benefit to the patient. Manns brings more than 25 years of industry experience, including leadership positions in PPD’s innovation and operational teams.

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