BBK Worldwide launches patient-centric trial resource
BBK Worldwide has announced the creation of its Engagement Solution Center, a new resource designed to centralize design, management, operations, and communications of various patient-visit support services. The center is geared toward easing the burden of research for rare and orphan diseases in addition to larger and Phase IV/V studies.
Outsourcing-Pharma discussed the Engagement Solutions Center with Rob Laurens, principal at BBK Worldwide, including the growing shift to decentralized and the impact of COVID-19 on the clinical trial landscape.
OSP: Could you please share some of the conversations (internally, and with customers) that helped lead to the creation of the Engagement Solution Center?
RL: As you can imagine, there were many conversations that informed the development of the Engagement Solution Center. We heard from customers about their immediate needs in the wake of COVID-19 – including concerns about supporting a shift to decentralized clinical trials.
We heard concerns about everything from solution management and technology integration to site burden and patient engagement. In one form or another, these are all addressed in the Engagement Solution Center as it centralizes the design, management, operations, and communications of patient-visit support services while eliminating barriers to participation.
We also heard concerns from sponsors about perceived risk associated with decentralized clinical trials from a performance and regulatory perspective. With the launch of the center, they can now feel confident working within a decentralized model.
Internally, our conversations focused on the patient and creating a more comprehensive experience. We always came back to the vision that it had to focus on the needs of the individual patient, and not on pushing the service offerings as utilities.
OSP: Was this something in the works pre-COVID?
RL: Yes, it has been in development, but COVID-19 provides an example of the broad-based utility of it. Of course, it has great utility for any study, but if you suddenly have to change or expand the support you are providing to patients – suddenly adding home health visits, medication delivery, or telehealth for example – it does so, underscoring the inherent value of a centrally-managed approach.
OSP: Please describe TrialCentralNet, and how it plays an important part in the solutions offered through the new center.
RL: TrialCentralNet (TCN) is our technology portal through which everything from study recruitment, prequalification screening, travel arrangements, and reimbursement to interpreters, medication delivery, home health visits, and digital study tools are centrally managed. It’s not only the network for providing the service but for monitoring, measuring performance, planning, and course correction. Everything is interwoven with the technology. It allows service providers, and even subcontractors and independent sub-contractors such as home health or ground transportation, to be part of a seamless process.
OSP: As you mention in the announcement, your company has a “no patient, no site left behind” philosophy. What does that mean exactly, what challenges does that create, and how does that approach benefit folks along the study pipeline (sites, sponsors, patients, etc.)?
RL: For patients, it means that every patient can have the types of services they need in a seamless, single delivery modality. From a site standpoint, it’s basically one-stop shopping without having to engage and train various vendors.
For sponsors, similarly, they don’t have to engage with a multiplicity of sub-contractors; they only have to engage with a centralized contact. Sponsors can certainly have input into who those subcontractors are but they don’t have to expend the time managing them.
“No patient, no site left behind” alludes to the fact that everything is fully tailored to the study design. It considers what the site wants to do – some sites for example won’t want home health even if it is offered through the protocol. The investigator may not want to do it, or the patient may not want to do it for cultural reasons.
Our approach doesn’t force people into a one size fits all scenario. It gives people what they need in the manner that’s going to maximize the purpose of what they are being provided and thereby maximize their retention and compliance. It doesn’t seek to provide a commodity. It seeks to solve the problem on an individual patient and site basis.
OSP: Can you talk about some of the common missteps trial teams are prone to making when it comes to patient-centricity, in terms of patient ID, recruitment, enrollment, and engagement?
RL: In the last few years, clients have begun to realize you have to plan for recruitment and retention, and retention came a good number of years after recruitment – in fact, many are just starting to do it. Understanding and supporting the patient should be considered as part of the protocol development just like patient recruitment and feasibility.
The common mistake is to follow the pattern of tack it on later as opposed to thinking what would it be like to be a patient in this study for the entire journey. It’s recognizing this is exceptionally complex, especially for rare diseases and most of the big studies going on now, and engaging expert assistance.
As there are a number of solutions available, some sponsors may be inclined to mix and match based on cost or ease as opposed to what makes the best sense for creating a complete infrastructure. There may be good reason to combine different vendors but it should be done in consultation and with good strategic purpose.
OSP: Just to clarify: is the center a physical facility, a suite of patient-centric services—or both?
RL: It’s not a physical center. The Engagement Solution Center operates as a center of excellence with patient-centric solutions, a central portal, and concierge-level services delivered with patient empathy and care. It addresses the challenges of a decentralized environment by centralizing management, communication, and operations while creating human connections that drive engagement.
The Center has a consultative component that provides a check and balance, ensuring the best solution is used for the situation. If a particular solution is not culturally appropriate in a region, we make unbiased recommendations for alternative solutions. We know the variables that can affect each disease state and we anticipate patient and site needs, saving customers time, energy and expense while ensuring full support for each patient.
OSP: Do you have anything to add, about the center, BBK, or any announcements you’d like to preview?
RL: The nature of decentralized clinical trials has the potential to make it difficult to maintain the human connection that drives patient engagement. This new center pays homage to the fact that relationship-building begins with the first moment a site or patient becomes aware of a clinical trial opportunity. The nuances of our services, combined with our concierge-level delivery, create those important human connections that drive engagement.
In terms of a preview, we will have exciting news about our technology later this year. It will be in line with our tradition of recruitment and engagement excellence.