In the Year 2022 and Beyond

In the Year 2022 and Beyond


We are all hoping that 2022 will be a better year for the world, one where the impact of the pandemic truly begins to subside for everyone around the globe. That said, it is a basic truth that every challenge presents some opportunity, and the impact of COVID-19 on the clinical research and development industry has been no exception.

As the chief patient officer for BBK Worldwide, I guide the development and delivery of the many BBK offerings that make clinical trial participation possible for study participants around the world. Without doubt, 2021 required the best our team had to offer, and I’m proud to say that they rose to the occasion. I’m also very excited to say that many of our team’s agile and innovative responses to the unique challenges presented to us by the pandemic have not only become permanent enhancements to BBK’s products and services, but also, I believe, will prove to be indicative of where patient engagement more generally is headed.



Let’s start with the team I just referred to – what we at BBK call the Concierge. The Concierge provides high-touch management of the many services that support our clients’ clinical trial participants and their study providers. We’ve all seen the term concierge being picked up throughout the industry in the past couple of years, but one thing I believe we’ll now start to see is greater sponsor understanding of what the term concierge can and should mean. To spell it out, I’m referring to thorough, thoughtful, well-planned, well-outfitted, and well-executed patient-centric programs – particularly in such offerings as travel management and home health – that address not only the specific needs of the patient population in a given study, but also the idiosyncratic needs of the individual participant. For example, it’s one thing to tout global travel capabilities with concierge service; it’s quite another to enable patient families to successfully travel internationally despite rapidly changing COVID travel restrictions and other confounding obstacles – such as an initial lack of passports and visas, the absence of a family’s financial resources, and in as little time as three short weeks. While travel scenarios of this complexity may not become more commonplace for all clinical trials, they will surely increase for those harder and harder to enroll studies within the industry’s hottest therapeutic areas. As a result, the capability to rapidly integrate and implement intricate travel solutions will become more readily required. Said differently, a commoditized approach that leans on patients’ own wherewithal and resources, and that lacks close, committed, proactive management, will quickly become a less favored choice for sponsors.

In a similar vein, we’ve already seen a sea change in sponsors’ appreciation for the long-term stay / temporary relocation option for studies that require patients to not only travel far distances, but also attend a series of study visits in fairly rapid succession. The potential ramifications of back-and-forth, home-to-site travel – particularly amid this pandemic – will come to be more readily recognized, and wise sponsors will want to focus on maximizing outcomes, rather than having participants undertake unnecessary risk.


With this understanding, it’s also fairly well assured that the newly tapped potential of hybrid trial designs will increase. In turn, this will pave the way for remote visits to become more frequently incorporated into protocol designs and, thereby, for home health services to become far more commonplace in countries where heretofore they have not been readily recognized as a standard element of study conduct.

Likewise, decentralization of many study services – or, perhaps better said, increased use of specialized services that can be better attenuated to the needs of a specific study participant profile – will shift from a curiosity to a commonality, if only, again, to maximize outcomes – particularly for those studies serving fragile patient populations.

Also – as I gaze into BBK’s crystal ball – I see that innovation in delivering patient accessibility and convenience with regard to engagement and support services is about to explode. I’d say more, but that wouldn’t be good business practice, so I’d encourage you to keep an eye on BBK’s email announcements and website this year.

Lastly, now that patient centricity has found its rightful place smack-dab in the center of our industry’s collective consciousness, it’s my prediction that site centricity is just around the corner – if not this year, than surely the next. Site centricity will take the form of sponsors seeking out companies that can truly deliver a higher level of service and expertise, as well as products and technologies that unburden study providers. The companies that will define this new market imperative will be those that can move investigators and their staffs away from demurring or dismissive attitudes about patient engagement programs and instead empower those same providers to more efficiently and effectively deliver study-related care in all its permutations to patients and their caregivers.

In short, both the persisting challenges of the pandemic and the growing expectations for the personalized delivery of healthcare will drive an increased demand for quality, customizable products and services for study participants and staff members alike.

Topics: Rob Laurens, Decentralized Clinical Trials, Hybrid Clinical Trials, Crystal Ball, Concierge, Site Centricity