How AbbVie Is Shifting the Focus from Decentralization to Patient & Site Centricity
Christie Fry, Director of Patient Centric Trial Design (formerly Decentralized Clinical Trials) at AbbVie, tells us how her team is prioritizing patient flexibility and site optionality in the next evolution of introducing innovation into clinical trials.
Your team’s name shifted away from “decentralized clinical trials” to focus more on flexibility and optionality for patients. Why make that change?
The demands we experienced during COVID abruptly (in a positive way) challenged us to meet patients where they are. As COVID subsided, we realized our focus of ‘patients first’ would indeed remain to ensure flexibility and optionality are always our first consideration in our trial design.
To that point, as we grew farther away from a daily concern over pandemic drivers, the word “decentralized” resonated with our study teams as an activity that needed to be “remote”. We chose to bring our focus of patient centricity to the forefront, starting with name recognition of our team’s primary remit.
"We need to equally address site burden – they are our critical partners in trial conduct and oversight."
When you make the shift from decentralizing aspects of clinical trials to ensuring optionality and flexibility, how does decision making change?
Our focus transitioned to not only securing direct patient insights around a disease area, but also taking the opportunity to conduct interviews, panel sessions with patients around aspects of protocol development. Understanding, first-hand, what options and levels of flexibility may need to be in place to make their trial participation experience more convenient and less burdensome.
An example that often presents itself are visits dedicated solely to lab collection. These visits don’t often coincide with time with the PI, so perhaps a more locally-based lab may be optimal. We sometimes forget industry data mentions 60% of patients travel over 30 minutes each way to a study visit.
Therefore one hour or more in travel, with a 30-minute visit requires planning (time off work, travel with child, etc.), so we propose options to ease the study requirement burdens. Therefore the patient may have three options embedded in trial design – visit a local lab collection site, in-home microsampling device, or travel to the site.
Why is optionality such an important area of patient experience to focus on?
It is important to remember from a patient’s perspective, disease management and trial participation may be separate. Receiving a new diagnosis or a change with existing disease progression, is often overwhelming within itself. Then layering in the decision to participate in a clinical trial, may compound the impact on schedules, time away from work, away from children, costs for travel and ancillary needs.
Therefore, it is critical for sponsors to understand a patient’s journey, aspects of daily living with a particular disease and make every effort to meet the patient where they are.
"We know when patients are more informed, they are more engaged and likely to remain committed to trial participation."
What is the process of embedding patient-centric aspects into trials?
Our team partners closely with our feasibility team, study team, scientific and medical directors, highlighting patient and site insights around a disease area, customizing the flexibility and optionality required to optimize our protocol to address all levels of patient burden.
How do you facilitate insights from patients to bring back to study teams?
AbbVie is very intentional about securing direct patient and site insights to drive every aspect of our clinical trial conduct – from the asset strategy level, to study closeout and follow up.
To that point, we have a very robust infrastructure responsible for harnessing feedback from patients, sites and caregivers and driving delivery of that feedback to key stakeholders across the organization providing input and expertise to each and every trial design.
Where have you found success in making things more accessible for patients?
We know when patients are more informed, they are more engaged and likely to remain committed to trial participation. There are differing levels of trial accessibility we address and support, depending on required study activities/procedures and potential length of trial. At a foundational level, ensuring patients have information and resources at their fingertips is essential. The transition to digital occurred years ago, and has now increased to older generations, whether it is via smartphone, tablet or laptop. That level of increase offers improved modes of communications right from the start – from recruitment, consent and daily diary completion.
As patients progress through the trial, access to information at their fingertips continues to be critical to deliver their schedule of events, reminders and notifications for study activity completion, image capture, survey distribution to understand patient level of satisfaction, reimbursement and travel support and coordination for lab collection, etc. Thank goodness, every day in our industry is a new day where technology is at the forefront of brilliant minds assessing new ways to keep patients and caregivers informed and educated about next steps.
What are your thoughts on potential site burden when introducing digital innovations for patient benefit into trials?
As we think about increasing trial accessibility for patients and caregivers by incorporating various technologies, we know that inherently moves the needle on site burden. Many times the training and management of those digital interactions with patients is passed on to the site. A lot of the technologies sponsors incorporate into a trial are developed and launched via a vendor, which requires sites to interact with a vendor’s product and/or interface.
There could be as many as 12 different vendors supporting one trial, which may mean 12 different dashboards, training and reporting required for each vendor. We need to equally address site burden – they are our critical partners in trial conduct and oversight – bringing single sign-on platforms may be one way we deliver that commitment to our site partners.
"As COVID subsided, we realized our focus of ‘patients first’ would indeed remain to ensure flexibility and optionality are always our first consideration in our trial design."
What are you hearing from sites, in terms of burden or what they want from pharma?
That sites don’t want shiny new objects as much as they want clear and accessible communication. Centralized communication channels are critical to deliver a streamlined and efficient environment for sites eliminating the need for multiple calls/emails to seek answers to questions. Referring back to a question you asked earlier – how do we facilitate insights from patients to bring back to study teams – our infrastructure is responsible for securing constant insights. Feedback from sites provides an outline for our organization of how we can ensure we are a sponsor that achieves that tailored experience for an optimal partnership.
The Patient Centric Trial Design team also leads eConsent implementation at AbbVie – helping to ensure sites have optionality and flexibility in eConsent delivery. The pandemic drove some sites to secure their own eConsent solution. Therefore, when we launch eConsent on a trial, we work with each site to understand their preferred method for delivery – some may insist on using the traditional paper delivery, some use their own solution and others may be content on using the sponsor-provided solution. We are grateful for our site partners and want to ensure they know they are important to AbbVie.
