Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
Meet the Expert: Shelby Stillwagon, Sr. Director, DCT
I oversee our Decentralized Clinical Trial (DCT) services. With any DCT solution, our goal is to make patients’ lives easier, truly leaning into the concept of “patient-centricity”. Our team works with sponsors to design and implement procedures that support the study outside of the traditional site environment. Patients may have an already busy schedule, have limited mobility, or rely on a caregiver – all of which make it difficult to travel to the site frequently for visits.
When clinical trial activities can be done in the comfort of the patient’s home, we eliminate the need for the patient travel to a traditional study site to participate, enabling greater participation across a larger geographic area and a more diverse pool of patients. With increased recruitment and retention, sponsors can bring treatments to market faster, allowing them to improve the health of more patients.
Nothing ever goes exactly to plan. Being highly adaptable and flexible is critical for success in DCT because we are working outside of the traditional, controlled study site environment.
We face new and unusual challenges every day. We must be hyper-focused on all logistical details and even when we think we have accounted for every possible issue or outcome, something unexpected happens – weather limits IP or lab sample delivery, technology goes down, blood collection tubes fail, equipment malfunctions. So, in our space, we have to be quick on our toes and able to problem-solve in real time.
I enjoy learning about new, cutting-edge treatments and collaborating with sponsors to develop creative, flexible solutions for patients. When a client comes to us with an interest in decentralizing their trial, we have the opportunity to evaluate their current protocol or draft schedule of events and provide guidance on what activities can be done remotely – whether that be with home visits, telehealth, or other technology. It is exciting to be a part of the development journey and to offer feedback on how the study design can be refined to allow for greater patient satisfaction and increased recruitment.
Digital health technologies and remote data collection. Nearly everyone tracks some aspect of their health using a smart watch or app on their smart phone. We are counting our daily steps, measuring our heart rate during a workout or checking to see how well we slept the night before. We have more data available to us than ever before and this can be used to get a more complete picture of the patient during a clinical trial, but it doesn’t come without its challenges.
The FDA recently released a guidance on Digital Health Technologies and Remote Data Acquisition noting the regulatory considerations when selecting and validating new technologies, and what risks should be considered with evaluating data collected remotely using technology. Incorporating additional technology into your trial can further benefit the patient and allow for more comprehensive data collection, but it’s difficult to know where to start. Our team works to understand the needs of our client and study to provide guidance on what solutions may be best to support the study goals.
When working with our team, clients gain expert guidance on decentralized study design and implementation. Our team has been working in the DCT space as long as the DCT space has existed. We’ve experienced firsthand the evolution towards decentralization across the clinical trials industry. From pre-COVID when incorporating DCT was new, uncomfortable, and “nice to have”, to the height of the pandemic where the only studies that survived were those that already had or were able to quickly implement decentralized visit activities.
Our team is eager to collaborate with clients to understand the intricacies of their study and any issues they anticipate with recruitment. Bringing us on early in the process, allows us to plan ahead, standardize our approach, and provide thoughtful solutions to complex challenges.
When executing decentralized visits, we pride ourselves in our employee nurse model. We find that employing and managing nurses directly ensures our nurse team is qualified, well trained, and have appropriate clinical support.
March 21, 2022
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
March 21, 2022
Data collection and analysis is expensive and has the potential to compromise a company’s hard-won compliance position. It is therefore critical that technical leaders follow a systematic and proven...