Is your volunteer management strategy improving your success of achieving endpoints in Phase 1 trials?
On April, 15 2020, at 2:00pm EDT (11:00am PDT), WCCT Global conducted a webinar on the following topic:
Achieving Endpoints and Phase 1 Trial Objectives through Superior Volunteer Management: Three Experts Share Their Strategies and Experience
View the Recording here:
Conducting a Phase 1 trial is not simply a box to be checked in your compound’s clinical development program; there are no shortage of complexities to be discussed, and strategic decisions to be made. The most important aspect of executing a Phase 1 clinical trial is to identify participants and adequately prepare them to fulfill study requirements. Therefore, consideration should be given towards the thoughtful management of trial volunteers during this stage of your product’s development life cycle. However, generating data that is as comprehensive as possible to provide evidence for scientific claims is the primary purpose of clinical research, and thus, this goal needs to be prioritized as well.
Sponsors should ask themselves: “How can Phase 1 clinical trials be designed and executed such that participants are given an optimal research experience, while still capturing all the necessary data to move on to the next stage of development?”
In this webinar, WCCT posed strategies for thoughtfully designing Phase 1 trials to accommodate volunteers’ preferences and expectations—taking into consideration how study design will impact patient recruitment activities—while not sacrificing on the procedures and assessments necessary to produce the data you need to achieve your objectives.
Our experience as a Phase 1 CRO demonstrates that when clinical research participants are carefully managed during a Phase 1 clinical trial, that project is is more likely to meet its objectives and generate the necessary data to advance on to the next stage of development.
The speakers offered strategies for Sponsors, early phase CROs, and Phase 1 sites to consider when developing a “volunteer-centric” approach for executing clinical conduct activities which will increase your chances of success when recruiting and retaining trial participants, resulting in a fully-completed clinical study without deviations or delays.
- How to design and plan Phase 1 clinical trials to enable “Superior Volunteer Management” with a focus on:
- I/E Criteria
- Procedures and assessments to be performed
- Structuring study visits and volunteer commitment
- Strategies to prepare volunteers for success (a.k.a. ensuring compliance and retention)
- How to better understand the clinical research volunteer of today (what they know, who they know, what they expect) and how to consider that profile when executing Phase 1 studies
About the Presenters
Sammy Armado, Director, Volunteer Recruitment & Engagement, WCCT
Sammy Armado has been with WCCT Global for seven years and currently oversees patient recruitment and volunteer retention and engagement initiatives. Sammy is responsible for developing unique recruitment and retention strategies to manage each study from start to finish. With his time at WCCT, Sammy has led the successful enrollment of many complex trials that include normal healthy volunteers, ethnic and special populations.
Talia Nikolao Hight, MBA, Biopharma Professional
With 17 years of experience in the drug development industry, Talia Nikolao Hight has amassed a wide range of knowledge extending across clinical operations, business operations, and clinical site management. Talia began her journey in clinical development as a Clinical Research Coordinator at WCCT Global, and then moved into a variety of management roles as the company grew from 15 employees to 200+ employees.
David L. Wirta, MD, President & CEO, The Eye Research Foundation and The Aesthetic Eye Care Institute
Dr. David L. Wirta (MD) is a board-certified Ophthalmologist and an accomplished specialist in cosmetic eyelid surgery, eyelid and tear duct plastic and reconstructive surgery, as well as medical diseases of the eye. Dr. Wirta has been the President and CEO of his own Ophthalmology practice, The Aesthetic Eye Care Institute, for over twenty years. Dr. Wirta holds his medical degree from UCLA, and he completed a surgical and medical internship at the Harbor-UCLA Medical Center.
DOWNLOAD THE PRESENTATION
Click the link below to download the webinar presentation slides.