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Creating a Patient-Centric Environment for Decentralized Clinical Trials

Ebooks & White Papers March 15, 2022

Introduction

In our newest Focus 5 publication, Chief Patient Officer Rob Laurens and Lead Concierge Anthony Gaudio answer five questions about decentralized clinical trials and BBK’s efforts to help ease their adoption. As experts on the front lines of patient engagement, they share their unique insight and discuss how BBK’s newly launched Engagement Solution Center creates a patient- and site-centric environment for enrollment and engagement success.

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HEAR FROM THE EXPERTS

As decentralized clinical trials reshape the clinical research landscape, BBK Worldwide experts Rob Laurens and Anthony Gaudio discuss efforts to help study sponsors embrace these trials with ease and confidence.

 

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Rob Laurens

Chief Patient Officer, BBK Worldwide

 
An industry veteran instrumental in advancing the patient-centricity movement, Rob oversees BBK’s patient support services and drives innovation to support patients and site staff as the industry embraces decentralized clinical trials.

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Anthony Gaudio

Lead Concierge, BBK Worldwide

 
As lead concierge, Anthony engages directly with patients and site staff to implement BBK’s decentralized services (including travel, reimbursement, medication delivery and home health visits) and provides support at key touchpoints in the clinical trial journey.

 

QUESTION 1

How does BBK’s Engagement Solution Center help study sponsors to conduct decentralized clinical trials?

ROBRob Laurens
Chief Patient Officer

Our Engagement Solution Center was inspired by the need to help study sponsors engage patients outside of a traditional clinical trial setting. It features concierge service delivery and a robust patient experience portal to ease the clinical trial journey. We have a team of concierge specialists who implement our patient support services. They are seasoned individuals, empathetic to the needs of patients and supportive of the needs of site staff. They understand the complexities of a decentralized environment and are experts at solving complex challenges that can jeopardize patient compliance.

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Concierge service delivery provides sponsors with the confidence they need to fully embrace solutions and ensure patient and site needs are met.


Our Engagement Solution Center addresses some of the operational complexities associated with decentralized clinical trials. Our central platform TrialCentralNet® tackles issues associated with multiple vendors and systems, as well as the integration of data — reducing some of the operational burden for sponsors and site staff. The platform also creates efficiencies by centralizing the management, communication and operations of patient support services.

 

 

The Engagement Solution Center is a one-stop global shop for decentralized clinical trials, providing study sponsors with a full range of patient-centric solutions — including medication delivery, home health visits, telehealth, reimbursement and travel — with patient-by-patient customization built in.

 

 

 

 

 

 

 

 

 

 

QUESTION 2

You had to find ways to make sure that clinical trial participation could continue during COVID-19. Are there lessons learned that you can apply to decentralized clinical trials?

ROBRob Laurens
Chief Patient Officer

We’ve always embraced a “no patient, no site left behind” philosophy, which was critical during COVID-19 and now critical for decentralized clinical trials. Our solutions are always tailored to the study design. If a particular solution, such as home health visits or telehealth, is not culturally appropriate in a region or perhaps not supported by a principal investigator, we make recommendations for alternate solutions to ensure the greatest opportunity for inclusion.

 

Our concierge specialists know the variables that can affect each disease state and can anticipate patient and site needs, saving sponsors time, energy and expense while ensuring full support for study participants.

Customization is built into our approach so we can adapt our services to meet local or site-specific needs. This ensures that no patient is left behind — and for that matter no site is left behind.

One example I like to share is from the height of COVID-19. Brazil — one of several countries we were supporting for a global study — went into lockdown, putting patient compliance at risk. Our team quickly pivoted to replace in-person visits with medication delivery. Study medication was packaged at the site and then shipped directly to patient homes using ground and air methods. The shipments were temperature controlled and ready for patients to self-administer upon delivery. With this adjustment, I am happy to say that the study remained on track.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

QUESTION 3

As you work with sites on a daily basis, what are some of the challenges you see confronting staff as they conduct decentralized clinical trials?

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Anthony Gaudio
Lead Concierge

One of the biggest things that strikes me is increased site burden. Study coordinators are being asked to do a number of things that go beyond the standard patient study visit, including juggling multiple systems and services. Many of their new responsibilities have come about quickly, often leaving little time for training.

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As concierge specialists, my team and I do as much as we can to alleviate site burden. Our services run the gamut from coordinating complex travel and medication delivery to managing reimbursement and referrals. Our support is nuanced — we don’t just offer travel, but we assess the entire environment to ensure all needs are met. This can mean anything from providing a translator or ensuring a vehicle is wheelchair accessible to securing a visa or arranging for additional support services for an extended stay. However, our goal always remains the same — to remove site burden and create connections that drive enrollment and engagement.

Another concern I see is the challenge to maintain human connection. The very nature of decentralized clinical trials makes it difficult to maintain the connections that drive patient engagement. We counter this with our patient support services that create meaningful engagement at key touchpoints along the patient journey.

The remote nature of decentralized clinical trials can make it difficult to maintain the human connection that drives patient engagement. Our concierge service delivery models what it means to be patient-centric in a decentralized clinical trial environment. The nuances of our services, combined with our delivery, create those important connections that drive engagement.

 

QUESTION 4

How can we better support site staff as they juggle new responsibilities associated with decentralized clinical trials?

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Anthony Gaudio
Lead Concierge

It is important to ease site burden as site staff acclimate to new tools and technologies. Not only do our programs help to reduce burden, but our personalized support does as well. Site staff have access to concierge specialists like me who can help diagnose problems and identify solutions.

We work to understand each disease and try to learn about the patient experience from sites so that that we provide solutions with empathy and care. We also work to ensure that programs are easy for sites to understand and include training and real-time support. For me, it’s always important that site staff know that extra support is available whenever they need it — and they always seem very appreciative. I think they also appreciate the relationship, knowing that they have a dedicated concierge specialist who understands their patients’ needs and how best to assist — essentially that we’re with them for the entire journey.

As the marketplace shifts and expectations for patient centricity are enhanced, study sponsors will need to collaborate with a solution provider that can not only deliver patient-centric services but also partner with sites. The burden of patient centricity cannot be all on the sites. The systems and services for decentralized clinical trials must consider site staff involvement as they engage directly with patients.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

QUESTION 5

How does concierge service delivery help create a positive patient experience?

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Anthony Gaudio
Lead Concierge

It does so by putting the patient experience at the center of what we do. Our Engagement Solution Center anticipates what is needed to support each patient in each trial. Our concierge delivery is supportive and recognizes that each situation may need a different solution depending on a number of variables. We work to fulfill patient and site needs, but we also anticipate what future needs may arise depending on the nature of a disease or the patient’s condition.

We recognize the impact technology can have on creating a more convenient patient experience, but we cannot ignore empathy and the importance of human connection.

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We’re focused on clearing the way for patients to achieve study-life balance by removing barriers that compete for their time and energy. By leveraging patient-centric solutions — delivered with empathy and care — we can enhance the patient experience in the broadest way possible.

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February 15, 2021

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