Clinical trial equity has become a major industry focus. While nearly everyone is on board with the shift toward inclusive research, the next step is putting these principles into practice. Lightship’s Sepehr Shojaei shares actionable insights for advancing equity in clinical trials in this MedCity News feature.

Definitions of key concepts including equity, inclusivity, and diversity

Factors influencing the current focus on diversity and why this matters

Steps to offer greater choice for clinical trial participants, enhancing inclusion in the process

What it means to think globally and act locally when it comes to clinical trial equity

Implementing Inclusivity: Putting Clinical Trial Equity Intro Practice

When a large global pharmaceutical company wanted to expand their reach through a hybrid trial approach, Lightship rose to the challenge. By offering flexible, off-site participation options, we expanded access, choice, and equity for this Phase III trial while meeting enrollment goals on an accelerated timeline.

The role of our site selection, off-site visit, and inclusive advertising strategies to deliver on trial goals

How our hybrid model expanded geographic reach

How providing the option for off-site visits allowed for greater patient choice

The results of our approach for improving equity and reaching underrepresented populations

In this case study, discover how Lightship expanded geographic reach and representation through a hybrid trial design.

Phase-III-Hybrid-Study-Case-Study.pdf

Download Hybrid Phase III Trial Case Study

Driving Access Through Hybrid Trial Design Case Study

Building a successful clinical research start-up is a high stakes endeavor, regardless of fluctuations in funding, the geopolitical climate, and macroeconomic headwinds. How can companies bring novel, innovative solutions that benefit investors, sponsors, investigators, and patients, and how can leaders work toward sustainable growth? The answer may be as simple (or complex) as business fundamentals.

Gain insights from Lightship’s co-founder, Samantha Eells, and CEO, David MacMurchy, on what a strong start-up needs to succeed. Read the full article in pharmaphorum.

Get insights from Lightship’s experts on the factors that drive long-term success for clinical research start-ups.

Which Companies Will Last? Success Begins With the Basics

Season of Giving 2023: An Inspiring Beginning

In 2023, Lightship and Acclinate launched our first annual Season of Giving — and it was a resounding success! Lightship and Acclinate are partnered to lead the way in offering more inclusive clinical trials by engaging people where they are. The first step to meaningful and trusted relationships with the people and communities we engage, is to give back to the communities we live and work in everyday​.

To honor the communities we serve, during November and December our teams across the United States volunteered their time to help the people and communities who give so much to us in clinical research.

“Lightship and Acclinate partnered to improve health equity in clinical research,” says Lightship Co-Founder Samantha Eells, “and by coming together to do the Season of Giving, we’re able to give back to the communities that give to us.”

We had fun and made a positive impact. Here’s a snapshot of the impact we made together.

In Birmingham, Lightship and Acclinate actively participated in a local initiative. Our teams came together at the Bush Hills Community Garden & Urban Farm, not just to volunteer, but to make a direct impact. We worked at the garden and helped distribute its fresh produce to local residents, directly supporting the health and wellness of the community.

This hands-on effort was matched by our involvement in the Bush Hills Community Holiday Gala, where we played a supporting role in bringing holiday cheer to the neighborhood.

Senior Director of Business Development Kyle Ashe of Acclinate summarizes our shared mission, “Our strategic partnership with Lightship is about improving access and education. Together, we’re not only pursuing business success, we’re committed to giving back to the community.” This sentiment fueled our actions as we invested our time and resources to support those around us.

Through these endeavors, Lightship and Acclinate have demonstrated a commitment to community engagement that goes beyond business as usual, reflecting a genuine dedication to the people who are at the heart of clinical research.

In November 2023, Lightship and Acclinate volunteered at the Los Angeles Regional Food Bank to help combat hunger. Sepehr Shojaei, VP of design solutions at Lightship, shared his thoughts: “Typically, our work with Acclinate is in reaching underserved populations in the clinical trial space and increasing access and choice. We wanted to work with them in giving back to our communities and supporting those who have supported us throughout the year.”

That day, our teams assembled 1,257 food packages for Los Angeles County families.

These packages are vital, as the LA Food Bank plays a key role in feeding those in need, delivering meals through local organizations and direct programs.

Samantha Eells, co-founder of Lightship, shared her perspective: “At the food bank today, we’re putting together packages of food to give to different folks across L.A. County. Lightship’s mission is to improve access and choice in clinical research, and overall drive better health equity for all. By giving back to the communities that serve us, this helps improve the engagement around how we work with the people who give to us in volunteering their time in clinical research.”

This day of service went beyond volunteering; it was a clear demonstration of our core values, showing our dedication to enhancing health outcomes and the well-being of the communities we serve.

Lightship-Season-of-Giving-LA_VF

In December 2023, our teams supported the Food Bank of Central & Eastern North Carolina’s efforts to reduce hunger:

This food bank serves 34 counties and distributes 2 million pounds of food per week

600,000 people in the region experience food insecurity — half of which are kids and teens, with the second largest group being senior citizens

Food goes from the Raleigh distribution center to partner agencies/nonprofits like food kitchens and schools, as well as directly to families in need

During our volunteer shift we helped pack 19,515 pounds of sweet potatoes — equivalent to 16,292 meals! 

Kim Rose, Lightship VP of legal operations and one of the volunteers, emphasized the importance of the initiative, “This is the first year that Lightship is doing a Season of Giving, and we’re all very excited about it, and partnering with our friends at Acclinate to do this. ... It feels really important to be involved in the community and to give back when we can. Community involvement and community engagement is critical to everything that we’re trying to achieve as a company. It aligns with our goals and our mission to expand access, increase diversity in clinical trials, and just be a bigger and better part of our communities.”

Kyle reinforced the collaborative spirit, “A big piece of what we’re doing at Acclinate — and at Lightship, too,” says Kyle, “is community engagement work. ... Let’s use our hands together. This is how you create partnerships.”

This initiative has allowed Lightship and Acclinate to offer vital support and reinforce our commitment to community and collaboration, central to our missions.

lightship-season of giving- raleigh_vF

In addition to the major city events hosted by Lightship and Acclinate, we had many team members who don’t live near one of these hub cities step up to create Season of Giving contributions of their own:

In Washtenaw County, MI, a team member participated in a weeklong event in collaboration with Kroger and Food Gatherers to raise donations for 1 million meals to feed food insecure families

In Orange, NJ, a team member volunteered with Friends of Metcalf Park cleaning up and repainting park benches

In Napa, CA, team members delivered 25 meals to homebound seniors

In Tampa Bay, FL, a team member volunteered for a mobile pantry called Feeding Tampa Bay

Every contribution, big or small, plays a crucial role in our Season of Giving, allowing every team member to join our mission of community support.

Lightship and Acclinate plan to continue Season of Giving events in 2024 and beyond and have invited additional health-focused and clinical trial industry partner companies to join in this effort.

“At Lightship, we spend every day trying to incrementally make the lives of our patients better by the way that we’re delivering clinical trials,” says Ellie Stewart, senior manager of design solutions. “What’s special about the Season of Giving is that generosity goes a long way and creates a positive cycle that impacts everyone’s life — not just the patients that we’re serving. … I love our partnership because it’s creating this positive cycle … for giving back and making sure we’re very community forward and community focused.”

Contact us if you’d like to be part of our next Season of Giving days of service. Together, we can make an annual impact on the communities that give their time to research.

Season of Giving 2023: An Inspiring Start

Rethinking Clinical Trial Community Engagement Through an End-to-End
Collaborative Approach

It’s no secret that improving clinical trial participation is essential, and it takes intentional
effort and careful planning to bring this goal to fruition. Rethinking how we approach
community engagement, with a focus on collaboration, can help drive results and build trust
in underserved communities.


In this presentation from Lightship’s Sepehr Shojaei and Acclinate’s Shayla Wilson,
discover:

Novel, collaborative approaches to community engagement for clinical trials, starting
from the top of the research funnel

Case studies that demonstrate the success of our efforts in improving trial access,
inclusion, and equity

Examples of innovative education and outreach strategies, from mobile research
units (MRUs) to community volunteering

Explore Lightship’s collaboration with Acclinate and our approach to clinical trial engagement in this presentation.

Scope 2024 Video

Rethinking Clinical Trial Engagement Through Collaboration

Lightship was thrilled and honored to participate in the 13th annual PharmaTimes Clinical Researcher of the Year – The Americas Awards. This competition included talented individuals and groups from across the pharmaceutical and life science industries, and Lightship’s Colleen Butler and Rachel Palumbo took home the GOLD prize for the startup team category. 

Check out this article in PharmaTimes for a recap of the event and a full list of winners. Congrats to all the finalists and champions! 

Start Up Team of the Year 2023 – The America's

This November and December, Lightship and Acclinate are working together on something new: their first annual Season of Giving. The two companies work together to provide more access and choice to patients, and to improve health equity in clinical research. Now, they are also teaming up to donate time and support to the communities where they live and work by encouraging team members to contribute to meaningful local causes.  

·      Los Angeles Regional Food Bank 

·      Bush Hills Community Garden & Urban Farm

·      Food Bank of Central & Eastern North Carolina

“This holiday season, we are giving back to communities that support us,” Lightship founder, Samantha Eells, explains. “People are the ones who make clinical research and advances in medicine possible, and we’re committed to giving back to them. That’s what this Season of Giving series of events with our partner Acclinate is all about — and we’d love to have even more clinical research industry companies participate.” 

Acclinate Chief Development Officer & Co-Founder, Tiffany Whitlow, is equally delighted to lead the Season of Giving: “By directly giving back to people in our communities in collaboration with Lightship and our community partners, we are continuing to bring our vision to life. We’re focusing on those most in need while honoring the communities that give to all of us.”

Lightship and Acclinate are extending an open call for other organizations interested in giving back to partner with them in future events. Use the contact information at the end of this announcement if interested. 

Lightship & Acclinate Season of Giving FAQ

What was the inspiration behind this first annual Season of Giving partnership?

 Lightship and Acclinate partnered to support more inclusive clinical trials that engage people where they are. An important part of engaging with and supporting communities that take part in clinical research is to give back in an ongoing way. This first Season of Giving is an expansion of Acclinate and Lightship working together to do more to support their communities.

“With Lightship celebrating our 5th birthday and this season being the 1-year anniversary of the Lightship-Acclinate partnership, it was the perfect time for us to plan to give back to the communities we live and work in every day,” says Samantha Eells.

Is there a long-term plan for community service and giving back?

Lightship has established The Lightship Giving Group, which will continue to offer quarterly support to community organizations year-round. 

“We plan to learn and grow from this first annual Season of Giving event series and go on to build programmatic support, engaging and giving back to our communities on an ongoing basis,” Eells says.

Acclinate, a digital health company for health equity, focuses on continuous and sustained community engagement for communities of color through their NOWINCLUDED community platform. This Season of Giving is yet another moment of service to support their communities. 

How did you select the organizations for the first annual Season of Giving?

“One in four people in the U.S. do not have enough food to eat — especially during the holidays,” Eells shares. “Volunteering at local food banks is one way to provide more hope for all, in alignment with Lightship’s mission.

Acclinate and Lightship also support the Bush Hills Community Garden and Urban Farm in Birmingham, which provides produce for their community while offering education for all to learn more about how to plant, cultivate, grow, harvest, prepare, and preserve to provide food. 

“We’re continuously investing in and empowering our Birmingham community to take charge of their own health by providing spaces for education, good nutrition, physical activity, and wellness,” says Whitlow. “In this Season of Giving — and all seasons — we want to invest in the places where many of our team and NOWINCLUDED members live, work, and play.”

How can my company partner with Lightship and Acclinate for this Season of Giving or future community volunteer events?

Acclinate and Lightship encourage the clinical research industry and health-focused organizations to join them in giving back to their communities. Use the contact information at the bottom of this news release to connect.

About Lightship: Lightship Inc. is a clinical trials service provider focused on increasing access and choice in taking part in research to improve equity for all. We design and conduct studies in partnership with biopharmaceutical companies to accelerate bringing new therapies to market. Our approach is to engage people where they are and support them across their journey in a clinical trial, from first contact to study completion. We work to make it easy, convenient, and safe for people to take part by offering visits in clinic, at home, using our mobile research units, and via digital health tools. By transforming the way we conduct clinical research, we can decrease study timelines, expand access, increase inclusion, and increase retention to accelerate development of better therapies. Learn more at Lightship.com, and follow us on LinkedIn.

About Acclinate: Acclinate is a digital health startup that is working to improve health equity through predictive analytics technology and community engagement. We specialize in accessing and engaging communities of color so they can make informed health decisions and learn about clinical trial participation. Through our online platform, NOWINCLUDED, we provide education, resources, and research opportunities to our community members. Learn more at Acclinate.com.

Lightship & Acclinate Season of Giving: Donating Time to Communities That Support Clinical Research

Join Medable, GSK, and Lightship's Sepehr Shojaei for a panel discussion on how a trial platform as a service can enhance, expedite, and improve the day-to-day operations of clinical operations across the life cycle of a study.  

Keeping Up with ClinOps: Why and How to Improve Delivery

Only 20% of clinical trial participants are people of color. Less than 45% of participants are women.1 At the same time, the FDA commissioner recently described “meaningful representation” in clinical research as “fundamental to public health.” 

The divide between current clinical research practices and those that effectively promote diversity is growing, due in large part to our increased awareness of what works and what doesn’t — what encourages broad participation and what discourages minorities from engaging with the process. That said, there is a critical difference between awareness and action. While many organizations may think it is important to create more inclusive clinical trials, they often lack the resources and the know-how to insert meaningful measures of equity and diversity into their trial design and execution.

In response, the Digital Medicine Society (DiME) has teamed up with industry leaders like Lightship and Acclinate to offer insight, support, and practical resources through the Diversity, Equity, & Inclusion Initiative. These resources are designed to provide actionable steps for transforming your approach to clinical research, and they are the beginning of creating trials that are person-centered and fitted for the future.

Now is the ideal time to take action against the lack of diversity in clinical research. Why? First, the representation gap is only growing the more we learn about the vulnerabilities of certain populations, making it increasingly paramount to align our research practices with our cultural realities. For example, Black Americans account for over 35% of kidney failure in the United States, while the number of Latino with kidney failure has increased by 70% in the past two decades.2 Unfortunately, these numbers are not represented in the populations actually participating in research, with less than 10% of both Black Americans and Hispanic Americans enrolled in clinical trials.1

These realities are rooted in mistrust, which is itself the product of years of unethical research and unfair treatment against people of color. Even today, many racial and ethnic minority groups (REMGs) don’t have access to quality healthcare, let alone the time and information to participate in clinical trials. This inequality is further reinforced by the troublesome logistics that often plague underserved neighborhoods and communities, such as a lack of public transportation or overall health literacy.

Additionally, modern technology is making it more feasible than ever to address these gaps in representation. Virtual participation in healthcare is at an all-time high with nearly 40% of U.S. adults taking part in telemedicine, and digitization is creating new options in nearly every corner of the clinical research process3: 

Clearly, technology is opening up many new doors in clinical research. That said, it is important that some of these new doors lead to greater diversity, and this confluence of urgency and ability is exactly what inspired Lightship’s collaboration with DiME.

The Diversity, Equity, & Inclusion Initiative offers the insight and digital tools necessary for developing person-centered strategies that increase representation in clinical trials. DiME encourages organizations to approach every clinical trial and patient community as part of a three-step process:

Lightship and Acclinate worked incollaboration with DiME and other industry leaders to develop a package of resources that promotes best practices across the industry, such as the tracking of diversity-related data via a “Diversity Dashboard” and building trust among marginalized communities through local partnerships. Each resource is informed by DiME’s three-step process, fully vetted and enhanced by Lightship and other experts:

These resources allow you to approach your clinical trials with confidence, knowing that the priorities and tactics behind your overall strategy covers all four levels of engagement: notify, solicit, integrate, and support. You will have provided knowledge and information (NOTIFY), empowered your participants (SOLICIT), developed trust (INTEGRATE), and advanced health equity (SUPPORT), ultimately creating more person-centered clinical trials. But, what do those trials actually look like?

 Lightship, along with its collaborative partners at Acclinate (see sidebar), has been dedicated to a people-focused approach to clinical research from the very beginning, so it should come as no surprise that our idea of “person-centered trials” is fully realized and established. Person-centered trials are the only types of trials capable of addressing present disparities, and these trials are defined by three basic tenets: access, choice, and equity.

Unfortunately, these areas of consideration, along with the needs of many REMGs, are often neglected in the face of a pressing timeline or budget, which is likely why 86% of clinical trials do not meet their recruitment targets. Of course, digitization is an excellent avenue for addressing these disparities, but it is only the beginning. Highly specialized expertise, diverse leadership, and a deep, practical understanding of different socioeconomic groups are vital to any successful implementation. Achieving this level of understanding is no small feat, and it requires those executing clinical trials to ask some very difficult questions:

Does my training emphasize cultural sensitivity?

Is my communication being customized to the community?

Answering YES to these questions means you are building a system that organically supports and creates person-centric clinical trials.

Acclinate’s NOWINCLUDED™ engagement platform and e-DICT™ predictive analytics are the perfect complement to Lightship’s tailored approach to clinical trial execution that creates more access, choice, and equity. As such, both organizations are actively teaming up on ongoing projects in the United States to generate meaningful engagement within diverse groups of highly representative patients.

Clinical trials need more diversity. It can’t be said enough. However, as Benjamin Franklin once wrote, “Well done is better than well said.” In order to facilitate a greater level of action, Lightship, Acclinate, DiME, and clinical research organizations around the world have put together a comprehensive collection of resources and digital tools that make transitioning to a more inclusive and person-centric approach as simple and straightforward as possible. The time to take action is now, and those who take action right away will be better prepared to execute their clinical trials well into the future. They will build trust within their communities and better understand each patient, all while producing more authentic and useful data sets. 
 
 Join us in shining a light on clinical research disparity. Access resources that will confidently guide your trial design toward a more inclusive, diverse, and equitable approach.

1 Algeria, M., Sudd, S., & Steinberg, B., et al.  Reporting of Participant Race, Sex, and Socioeconomic Status in Randomized Clinical Trials in General Medical Journals, 2015 vs 2019. Jamal Network Open. Published 2021 May. 

2 National Institute of Diabetes and Digestive Kidney Diseases. Race, Ethnicity, & Kidney Disease. U.S. Department of Health and Human Services. Last reviewed 2014 March.

3 Lucas, J., & Villarroel, M.  Telemedicine Use Among Adults: United States, 2021. Centers for Disease Control and Prevention. Published 2022 Oct. 

Research That Represents: DiME, Lightship, & Acclinate Collaborate to Support Inclusivity

Join Define Ventures' life sciences forum, Patient Centricity Meets Clinical Research: Next Gen Models in Pharma Innovation  and David MacMurchy, CEO of Lightship on Sept. 12th at 9am PT. During this panel, we will be unpacking how technology and consumer-first thinking can be implemented by sponsors, CROs, and startups to drive value for patients and the broader pharma ecosystem.

Patient Centricity Meets Clinical Research: Next Gen Models in Pharma Innovation

Lightship co-founder Samantha Eells was  featured in the Women In Pharma supplement of International Clinical Trials (Samedan Ltd). Click through for a thoughtful discussion about the impact of decentralization on clinical trial diversity.

Diversity, Digitalisation, and Decentralisation

Clinical trials play a pivotal role in advancing medicine and public health. However, traditional clinical trials often fail to provide adequate access and representation for diverse populations. In the latest episode of the HealthBiz Podcast, Samantha Eells — co-founder of Lightship — discussed her journey to revolutionizing clinical trials and improving the patient experience. Lightship aims to make clinical trials more accessible and patient-centric, with a focus on addressing health disparities.

Improving Access to Clinical Trials: A Conversation with Lightship Co-founder Sam Eells

Listen to Samantha Eells- Co-founder of Lightship, share her thoughts on tailoring recruitment strategies to meet patients' needs for successful trials in The Spark's latest podcast episode.

The Spark x Samantha Eells | Bringing a Humanistic Approach to Patient Recruitment

LOS ANGELES, NEW YORK, and LONDON; March 8, 2023 – Lightship Inc., a clinical research provider focused on increasing access and choice in taking part in clinical research to improve equity for all, today announced its meeting with the United States Food and Drug Administration (FDA) to discuss approaches in oncology clinical trials that offer more choice and access for patients.

 Lightship has developed an operational model for oncology trials that includes the benefits of home visits and locations closer to patients while ensuring appropriate safety monitoring and support. This approach provides greater convenience to patients, as it provides more access to people not living near a site and for those who find travel challenging. The operating model for this approach also allows the flexibility for investigators to see patients in the clinic for their ongoing care or research visits.

 In its meeting with the FDA’s Digital Health Technologies Steering Committee on February 10, 2023, the FDA provided feedback on various aspects of Lightship’s approach to oncology clinical trial design and delivery.

 This engagement serves to support oncology clinical trials, which are designed to offer more access and choice for people living with cancer to take part in clinical trials. Lightship plans to build upon this review process and continue to engage with the FDA and other stakeholders on approaches to support more inclusive clinical trials and improve health equity for all.

 “We are pleased with the collaborative and interactive meeting with the FDA about our clinical trial design proposal. With this insightful feedback and our foundational operating model, Lightship is well positioned to work with sponsors in designing and deploying more patient-centric approaches,” said Lightship CEO David MacMurchy.

Lightship Inc. is a clinical trials service provider focused on increasing access and choice in taking part in research to improve equity for all. We design and conduct studies in partnership with biopharmaceutical companies to accelerate bringing new therapies to market. Our approach is to engage people where they are and support them across their journey in a clinical trial, from first contact to study completion. We work to make it easy, convenient, and safe for people to take part by offering visits in clinic, at home, using our mobile research units, and via digital health tools. By transforming the way we conduct clinical research, we can decrease study timelines, expand access, drive diversity, and increase retention to accelerate development of better therapies. Learn more at Lightship.com, and follow on LinkedIn.

Lightship Inc. announces meeting with FDA’s Digital Health Technologies Steering Committee to review approaches to create more access and choice for oncology patients taking part in clinical research.

Lightship® Oncology Clinical Trials Operating Model Review With FDA Positions a More Patient-Centric Approach

The nonprofit Digital Medicine Society and industry collaborators, including Lightship, have launched anew resource platform designed to advance diversity, equity and inclusion (DEI) in digitized clinical trials.

New Initiative to Improve Diversity in Clinical Trials

For Lightship, increasing patient access to clinical trials is about meeting them where they are — literally.

To Drive Trial Diversity, Lightship is Bringing Them to the Patient

Meeting people where they are to increase access to clinical trials. 

How Virtual-First Clinical Trials Scale Access for Participants

Sepehr Shojaei and Rachael Scott discuss the use of hybrid clinical trial solutions across therapy areas. 

DCT Adoption Tracker: Exploring Trial Decentralisation Archetypes by Therapy Area

Building trust in clinical trials and creating non-biased data sets. Acclinate and Lightship discuss the importance of inclusion in clinical research. 

These Startups are Trying to Reach Communities Often Marginalized in Healthcare. Here's How They do it

Rachael Scott reviews the challenges and potential solutions for more inclusive clinical trials. 

Removing Barriers: Improving Diversity in Clinical Trials

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WEBINAR: Diversity in Clinical Trials - A European Perspective on Global Progress and Strategies

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