BBK introduces study-life balance construct

To participate in a clinical trial, a patient needs to take into account aspects of their life—busy schedule, family obligations, transportation access—and often must make sacrifices. Often, trial teams may not do enough to consider all a patient has to do to make participation possible.

Outsourcing-Pharma (OSP) recently spoke with Jessica Kim (JK), director of research and digital strategy for BBK Worldwide, about the importance of considering how trial participation might impact a patient, and how study personnel can better take the balance between research and real life into account.

OSP: Could you explain what you mean by “study-life balance”?​

JK: “Study-life balance” is a new construct that BBK Worldwide has introduced that looks at clinical trial participation within the context of a patient’s entire life experience. It represents an evolution in the clinical trial patient experience.

A good way to visualize it is to imagine the Wheel of Life – the popular coaching tool used to understand how balanced or fulfilled one’s life is. It usually has 8-10 spokes for areas considered to be important for a whole or balanced life – things such as work, hobbies, and social life.

With study-life balance, we’re adding a spoke for clinical trial participation, recognizing the role study participation plays in a patient’s life.

Study-life balance addresses challenges that appear as the result of the complexity of everyday life and the complexity of today’s clinical trials. It introduces patient-centric solutions that clinical trial sponsors can leverage to remove barriers to participation and create a positive patient experience; the solutions are customizable and flexible and range from travel, reimbursement, and virtual engagement to childcare, interpreter services, and meal delivery.

With the disruption caused by COVID-19, the construct of study-life balance is even more important for patients seeking to continue clinical trial participation or planning ahead for future enrollment.  

OSP: Why is it important for trial sites and sponsors to consider study life balance?​

JK: That’s a great question. It’s clear from BBK’s ongoing “Patient Voices” research that today’s healthcare consumer is empowered and has expectations for an enhanced healthcare journey.

The current approach to the clinical trial patient experience needs to be broadened to address the healthcare consumer’s desire for convenience, immediacy, and access to information; it needs to reflect a greater swath of the patient’s life. Study-life balance does just that; it provides clinical trial sponsors with a model that looks at the patient’s life and identifies solutions to make room for trial participation.

Helping patients achieve study-life balance is critical to the recruitment and long-term engagement of study participants. By leveraging flexible, patient-centric solutions, sponsors can help relieve patient pressure points and remove barriers to participation. 

Whether it’s providing a patient who has impaired physical mobility with a ride to and from study appointments, or it’s helping a family whose child has a rare disease travel halfway around the globe to participate in a study, they’re removing physical and financial barriers – equalizing participation opportunities in the process.

OSP: What factors come into play when we’re talking about study life balance? I.e. work, family, transportation, etc.?​

JK: Study-life balance addresses tangible and intangible factors such as travel, reimbursement, childcare, tutoring, interpreter needs, lost wages, relocation assistance, and medication delivery. At BBK, we’re basically looking at the person’s entire life, identifying areas that would be impacted by clinical trial participation and applying solutions to relieve the pressure points. 

OSP: Can you tell me how trial teams considered such things in the past—or did they?​

JK: We’ve all seen the movement from taxi vouchers and reimbursement checks to centralized patient travel and reimbursement programs over the years. But now we recognize that support needs to expand – especially as clinical trials become more complex; that’s certainly a driving factor.

If a clinical trial sponsor is conducting a rare disease study at only a handful of locations, but recruiting globally, they need to take into consideration potential needs. Babysitting and cultural acclamation were never a discussion point in the past – today it’s a common conversation we have with our clients.

OSP: What are the risks inherent in not taking those aspects of a patient’s life into account?​

JK: Patients who need care won’t be able to get it, or patients won’t be able to sustain clinical trial participation. Clinical trial sponsors will lose out on opportunities to engage patients who otherwise would be interested in participation.

By approaching the patient experience within the context of study-life balance, clinical trial sponsors can proactively remove barriers to participation, equalize participation opportunities, and increase access to care. 

OSP: Can you offer any information on how taking study-life balance into account might impact patient engagement/participation/retention?​

JK: There are several patient-centric solutions that clinical trial sponsors can leverage that remove barriers to participation and enhance the patient experience – and by doing so they will be supporting patient engagement and helping create that balance between study and life. Some of these include:

• Precision Support: aligns travel and reimbursement services to individual protocols and to the individual needs of participants based on medical status, lifestyle, cultural norms, and geographic location.
• Voice Assistants: provide enhanced convenience for patients and reduces study burden when used for recording health assessments, reminding patients about appointments, facilitating diary entries, reminding patients to take their medication, coordinating travel for study appointments, and answering study-related questions.
• Meal Delivery Services: remove the burden many caregivers experience in planning and preparing meals for loved ones.
• Dynamic Study Apps: provide patients with study-specific content that is educational and personal. Tools like appointment reminders, visit overviews, educational resources, and videos help organize the study experience.
• Study-Specific Patient Portal: empowers patients with valuable content while also providing opportunities for two-way communication between patients and study staff for enhanced engagement.
• Medication Delivery Services: transport the study drug to patients’ homes using a specialized home delivery service, reducing the number of in-clinic visits.
• Remote Study Visits: bring the study to the patient by arranging for a nurse or a member of the study staff to travel to the patient’s home to conduct routine blood draws or administer the study drug.

OSP: How does factoring study-life balance end up benefiting the trial team and sponsor?​

JK: Industry experts have long appreciated the impact a positive patient experience can have on clinical trial engagement. By approaching the patient experience within the context of study-life balance, clinical trial sponsors can proactively remove barriers to participation, equalize participation opportunities, and increase access to care.