Senior Director, Global Strategy
In a time of confusing terminology, one thing is clear: what the industry used to consider exceptional is now considered essential.
Hybrid. Decentralized. Remote. Digital. Virtual. Companies use these terms interchangeably. There is inconsistency, over-hyping, over-promising, confusion and a notable lack of substance. To be honest, it’s a bit like the Wild West out there.
While it is thrilling to watch our industry race to adopt these vital service innovations — to decrease site and patient burden, and increase access to clinical trials — the lack of specificity of the terminology in the field is problematic.
At BBK Worldwide, the idea of disentangling physical barriers to clinical trials — and identifying and solving clinical trial pain points — is not new to us. Years before COVID-19, we offered products and services designed to help patients mitigate challenges and inconveniences of clinical trial participation (via digital reimbursement cards, online travel support, centralized apps and portals, medication delivery, etc.). Now, in the wake of COVID-19, the imperative for structured, intuitive and flexible support outside of medical facilities is apparent to all.
At BBK, each of the following terms signifies a distinct subset of opportunity and need. We are intentional in the design of our various products and services, as well as in our use of terminology to describe them.
This is how we define the key terms.
Decentralized Clinical Trial (DCTs): a study that uses the strategic application of technology and off-site support to help extend trial availability into communities or populations that often lack knowledge of, or access to, clinical trials, and to make clinical trial participation a more seamless part of their daily life
- Remote / Off-site: trials that incorporate study visits / assessments at the patient’s home or by televisit to provide greater convenience and access (including medication delivery, home nursing travel, etc.)
- Digital: any trial support accessed through online technology (e.g., eConsent, televisits)
- Virtual: fully conducted in the digital realm requiring no physical contact between patients and investigators
Hybrid: a DCT that includes a traditional component or a traditional study that includes a DCT component
Traditional: a conventional clinical trial that requires participation on-site exclusively at a medical facility
We believe the flexibility and responsivity of these services combine to broaden the reach of patients for studies and the reach of studies for patients. When used strategically and purposefully, these innovative supports can be key to both sealing the deal at recruitment and bolstering commitment for greater compliance and retention. We start with clarity on the language and extend that clarity to our design and implementation.
One thing has become clear: what the industry used to consider exceptional is now considered essential.
As others scramble to jockey for position, we know where we sit. BBK has services and products that stretch the full spectrum — and we therefore consider ourselves at the head of the pack in delivering hybrid solutions that span this full continuum.
We welcome others to follow our lead in being intentional and precise about the powerful variety of solutions available to increase clinical trial access — as long as we have a shared lexicon with which to do so.