Conducting a Phase I trial is not simply a box to be checked in your compound’s overall clinical development program; it will set the pace and standards for the remainder of your product’s lifecycle, and there is no shortage of complexities and nuances to be discussed, and strategic decisions to be made. As with any other clinical study, the most important aspect of a Phase I trial is to identify participants and prepare them to fulfill study requirements. Therefore, significant consideration should be given towards the thoughtful management of trial volunteers during this phase of your program. Ultimately, however, the purpose of clinical research is to generate data that is as comprehensive as possible to provide evidence for claims, and this task needs to be prioritized as well.
Sponsors should ask themselves: “How can early phase 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, the featured speakers will pose strategies for thoughtfully designing Phase I trials to accommodate volunteers’ preferences and expectations—taking into consideration how study design will impact recruitment activities—while not sacrificing on the procedures and assessments necessary to produce the data you need to achieve your objectives.
By evaluating key areas of study design such as inclusion/exclusion criteria, procedural requirements, assessments to be performed, and inpatient vs. outpatient visit scheduling, we pose that early phase trials can not only be positioned for success in data generation and consumption but also create the baseline in ideas and activities that overcome challenges in volunteer recruitment and retention during the conduct for future studies.
Our experience demonstrates that when trial volunteers—healthy or otherwise—are carefully managed during an early phase trial, the trial is more likely to meet its objectives in generating the necessary data to advance on to the next stage of development. This not only involves educating volunteers and providing them with the necessary resources to participate in a study but understanding, managing and responding to their expectations when it comes to their participation.
The speakers will also offer considerations and strategies for implementing a “volunteer-centric” approach in executing Phase I clinical trials which will increase your chances of success when recruiting and retaining trial participants and achieving a fully-completed clinical study without delay or interruption. Lastly, they will discuss specific examples of how this type of approach was a crucial factor in achieving success during an early-stage trial.
Talia Nikolao Hight, MBA, VP, Commercial Operations, WCCT Global
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 started as a clinical research coordinator at WCCT, and then moved into a variety of management roles as the company grew from 15 employees to 200+ employees. Talia also has previous experience on the Sponsor side, managing Phase III trials in an orphan ophthalmic condition through to New Drug Application (NDA) submission. Her areas of therapeutic expertise include ophthalmology, respiratory, infectious disease, immunology, cardiovascular, women’s health and central nervous system. Talia brings a balanced perspective from both the contract research organization and sponsor viewpoints, as well as across the clinical drug development spectrum from early-phase to late-phase clinical trials.Message Presenter
Sammy Armado, Associate Director, Volunteer Recruitment & Engagement, WCCT Global
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. Sammy has implemented processes that drive protocol-specific planning and tactics for targeted recruitment. Sammy has recently taken the lead on efforts to enhance the patient experience at WCCT, leading the charge in their “Volunteers First” approach and initiatives. Additionally, Sammy has led the efforts for WCCT’s volunteer retention program that has led to exceptional results.Message Presenter
David L. Wirta, MD, President and 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. He completed his Residency with the prestigious Jules Stein Eye Institute at UCLA before finally completing a Fellowship in Ophthalmic Plastic and Reconstructive Surgery with the Casey Eye Institute at the Oregon Health Science University.
Then, in 1998, Dr. Wirta began his work in clinical research when he founded The Eye Research Foundation. The Foundation conducts clinical studies on glaucoma, blepharitis, eye allergies, dry eye, presbyopia, cosmetic neurotoxin and other eye conditions in order to further research for treatment and cures for these ailments. It is in this capacity that Dr. Wirta and his team are an invaluable resource to WCCT Global. Dr. Wirta not only serves as a Clinical Investigator in conjunction with WCCTG’s team, but he also provides essential insights into the conduct for Ophthalmology trials and assists with recruiting specialty patient populations. Dr. Wirta’s expertise in running complicated and detailed early phase ophthalmology trials merges seamlessly with WCCTG’s extensive resources, facilities and operations as a phase-one unit and CRO. Dr. Wirta has served as a Principal Investigator on over 200 clinical trials as well as published various peer-reviewed scientific articles about his work. Dr. Wirta is a Fellow with both the American Academy of Ophthalmology and The American Society of Ophthalmic Plastic and Reconstructive Surgeons.Message Presenter
Who Should Attend?
This webinar will benefit senior-professionals working at CROs, pharmaceutical, biotech and medical device companies. Specific job titles include:
- Clinical pharmacology personnel, including clinical scientists
- Clinical operations-focused executives and directors
- Project managers
- Clinical study managers
- Outsourcing/procurement personnel
What You Will Learn
Attendees will gain insights into:
- How to design and plan Phase 1 trials to enable “Superior Volunteer Management” with a focus on:
- Inclusion/Exclusion Criteria
- Procedures and assessments to be performed
- Structuring study visit commitments
- 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
WCCT is a full-service early phase contract research organization (CRO) for the pharmaceutical, biotechnology and medical device industries. We are specialized regulatory and clinical development professionals who offer an innovative, agile and collaborative approach to every program we deliver.
Our Mission is to achieve our Sponsors’ Early Phase clinical objectives of advancing global health. This is accomplished through the development of a scientifically-informed time and budget-sensitive design; and with clinical trial research service execution that delivers high quality data, a superior client experience, and a volunteer-centric approach to care.