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

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

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

Removing Barriers: Improving Diversity in Clinical Trials

Lightship® is delighted to welcome Michael (Micky) Cohen-Wolkowiez, MD, PhD as our Chief Medical Advisor. Micky is a Distinguished Professor at Duke University. Micky is a prolific researcher with over 170 publications in peer reviewed journals and brings to Lightship his experience of managing all phases of multiple therapeutic area clinical trials in adults and children. His research focus is patient-centric methods to accelerate the development of better therapies. 

Micky will help to further Lightship’s work of delivering clinical trials that create greater access and choice, with a focus on reaching underserved populations. He will be advising Lightship on its operational model and support a continued focus on the participant’s journey through the clinical trial experience. 

“Lightship has a unique research delivery model supported by exceptional people with decades of experience in clinical research, generating regulatory-grade data,” said Dr. Cohen-Wolkowiez, MD, PhD. “I am excited to play a part in advancing clinical trials in novel ways grounded in the reality of the participants, which is often overlooked when designing and implementing studies.”

 “We are pleased to collaborate with Micky to expand and enhance the experience for patients and providers,” said David MacMurchy, CEO. “Our model to support all clinical trials with a people-first approach can benefit in evolving with Micky’s wealth of experience in conducting research."

Micky is a Distinguished Professor at Duke University joining Lightship as Chief Medical Advisor. 

Dr. Michael Cohen-Wolkowiez Joins Our Team to Enhance Patient and Provider Experience at Lightship

David MacMurchy and Rachael Scott discuss how we offer more access and choice for patients in clinical trials. 

Sites on Wheels: Bringing the Clinical Trial to the Patient’s Doorstep

We are pleased to announce our partnership with Acclinate, a digital health company specializing in accessing and engaging communities of color to enhance clinical trial diversity. As partners, we will collaborate together on solutions to increase access to clinical trials and engagement of diverse populations and communities of color. 

“Removing common barriers to clinical trial participation such as geographic constraints or logistical concerns around traveling to a site, missing time from work or coordinating childcare, helps increase access to clinical research,” says David MacMurchy, CEO of Lightship. “Sometimes, people do not know how to gain access to clinical trials. Our partnership with Acclinate leverages their established, trusted community connections, digital platform and app with Lightship’s robust clinical trial infrastructure and commitment to meeting participants where they are to deliver their clinical trial.”                                                                                                                      

To read more about the partnership, check out the press release here. 

Lightship and Acclinate Announce Partnership to Increase Access to Clinical Trials for Diverse Populations

Authored by Kristin Croucher & David MacMurchy

Part 2 in a 2-part series. Access Part 1 here.

Providing a Consistently High-Level Experience

That feeling of familiarity and comfort, as well as the convenience, is why many clinical trial participants prefer to schedule appointments at home. Our research found that 85% of UK respondents and 79% in the US would be more likely to take part in a clinical trial in the future, if it were to be conducted at home or in a mobile research unit (MRU) (2).

Having the study appointment at home or in an MRU removes numerous burdens for the participant (and in many cases, for their care partners, as well). These locations provide a safe space that is more convenient and not as busy as many traditional medical facilities (a significant concern during the pandemic), and attenuates logistical pressures that a participant might face.

Safety and privacy are important considerations for all patients. For example, members of the transgender and non-binary community often face challenges and discrimination during medical appointments, driven in part by a widespread lack of understanding about health needs of the community by healthcare professionals. Visits by clinical research nurses at home, or in an MRU, provide an opportunity to offer a secure space for transgender and non-binary participants in clinical research (3).

Today’s virtual-first and hybrid models can deliver additional oversight and care, which have the potential to provide a consistently high-level experience that supports participants and care partners through the clinical trial experience. Within these models, technology plays an important role in empowering the participant (and in some cases, their care partners), enabling them to navigate the trial, the scheduling of appointments, and clinical trial procedures with greater ease, via their smartphone or tablet.

According to a study from The Center for Information and Study on Clinical Research Participation (CISCRP), poor communication was the top reason (18%) people cited for dropping out of clinical trials (4). With various apps now available, it is much easier for participants to be in regular contact with a research nurse or principal investigator, which helps to provide faster feedback and reassurance at every step. Visits can be scheduled to fit with the participant’s free time and the virtual-first approach enables them to receive reminders on their phone which also helps to reduce missed appointments.

A people-first approach, enhanced by new technologies, has the potential to improve recruitment, retention, and the overall experience for participants in a clinical trial. Designing studies that prioritise the people involved at every step – and choice for participants – is also integral to making clinical trials more diverse.

Reaching Historically Under-Represented Groups

Industry studies have emphasised the need for greater representation, not only amongst participants in clinical trials, but also among the professionals conducting them. A recent report by CISCRP found that nearly half (49%) of respondents said they would trust pharmaceutical companies more if they knew the company included a diverse set of participants in their clinical trials (5). CISCRP has found that black respondents (39%) were more likely to say it was ‘very important’ to have diverse staff versus white (25%) or Asian (27%) respondents (6).

A significant element of making clinical trials equitable is reaching communities that may have a generalised mistrust of doctors and healthcare, with attitudes based on both current and historic events. In the last 50 years, trust in medical science has declined, leading to difficult doctor-patient relationships, less patient compliance, and ultimately unrepresentative outcomes. In 1975, 73% of Americans said they had high confidence in medical leadership. Fewer than half that number (34%) felt the same way in 2018, according to a Gallup poll (7).

Collaboration across the healthcare industry can help change that. This calls for continuous community engagement and empathy on the part of clinical research enterprises, to strengthen trust in medical systems. Demonstrating a commitment to transparency about clinical research goals and outcomes is an essential part of this work.

Providing participants choices around their clinical trial is key for reaching groups that have been historically underserved by the clinical research industry and ensuring a quality experience. Colleagues talk about meeting participants ‘where they are’, and this needs to be achieved on several levels.

 Meeting participants on an emotional level requires a care team that they can relate to, and that understands their specific concerns. For example, language concordance between patients and doctors can build trust and help participants feel more supported, because anxieties around communication are alleviated (8).

Focusing on connecting with people in this way has a direct impact on the success of clinical trials – particularly when it comes to increasing access and reaching underserved populations.

Ever greater levels of commitment and creativity should be encouraged when thinking about community engagement and meeting participants in their neighbourhoods. Engaging with communities through a grassroots approach builds personal relationships, scales trust, and provides an opportunity to share information and awareness about the importance of participation in clinical research. For example, colleagues at Lightship have joined Alzheimer’s Memory Walk events to meet and support people with this disease and their care partners.

 Producing a model for more inclusive clinical trials starts with the human connection. Great strides are being made across the industry as a result of implementing new models that have a strategically creative and compassionate approach to clinical research as a healthcare option.

Improving the clinical trial experience begins with having an in-depth understanding of participants’ preferences. Take, for instance, participants being more likely to enroll in a clinical trial if appointments could take place at home or in a mobile research unit. MRUs have emerged as an alternative alongside community-based brick and mortar sites, outside of traditional settings for clinical studies, like hospitals or medical centres. They provide a ‘third place’ for clinical studies.

 Sociologist Ray Oldenburg defined ‘the third place’ as an informal public gathering place that serves the community. He said it is the social surrounding that is distinct from the two main social environments of home (the ‘first place’) and the workplace (the ‘second place’).

 Offering alternative visit locations and greater flexibility around appointments reduces the travel costs on the participants, and can ease or potentially eliminate work and childcare scheduling conflicts. This can make all the difference, particularly for the most vulnerable, who might otherwise be unable or unwilling to participate in a trial.

By giving people the choice of participating in clinical trials at a third place, they are no longer limited by where they live, or, in some cases, not being comfortable having someone visit them at home. MRUs scale an organisation’s ability to provide clinical care to participants who may not wish to be seen at home or work. MRUs can be customised to allow for participation in many different types of clinical trials. Bringing the clinical trial to the patient removes the burden of travel to and from a doctor’s office or research site, saving time, assuaging potential anxieties, and strengthening the healthcare relationship.

The clinical research enterprise is continuing to revolutionise how studies are designed and managed. This is making them more flexible and efficient, as well as helping to address the current problems with diversity in clinical trials. While technology is the conduit, it is people – the participants and staff – who are at the heart of this transformation.

The more we encourage collaboration within the industry that enhances the experience in trials, the greater the potential for ensuring future medical innovations based on a bedrock of truly democratic and diverse clinical research.

2. Lightship’s research was conducted in November 2021, with 1,378 people from both the US and UK completing the Decentralised Clinical Trial Market Research survey, carried out by Dynata.

3. Visit: ciscrp.org/working-towards-a- more-inclusive-environment-transgender-non-binary-participants-in-clinical-research/

4. Visit: ciscrp.org/wp-content/uploads/2021/11/2021-PIParticipation-Experience-Report-

5. Visit: ciscrp.org/wp-content/uploads/2021/11/2021-PI-General-Perceptions-Report-04NOV2021-FINAL.pdf

6. Visit: ciscrp.org/wp-content/uploads/2021/11/2021-PI-Decidingto-

7. Visit: scp-health.com/blog/impactfulstrategies-hospitals-can-use-toimprove-community-health-and-winback-patient-trust/

8. Visit: ncbi.nlm.nih.gov/pmc/articles/PMC6833293/

This article originally appeared in International Clinical Trials, August 2022

Kristin Croucher, Vice President of Clinical Operations at Lightship, is a life sciences strategist with two decades of managing a range of teams and implementing high-level, multi-national operations across Africa, USA, Latin America, Europe, Asia and Australia.

David MacMurchy, CEO at Lightship, is a leader in the healthcare sector with over 25 years' experience working for leading organizations in the life sciences industry. In previous roles, he collaborated with life science companies across the US, Europe and China.

People First: Enhancing Participant Experience in Clinical Trials, Part 2 of 2

Part 1 in a 2-part series. Access Part 2 here.

Taking part in a clinical trial can potentially place a considerable burden on participants and their families.  People who participated in a clinical study 20 years ago, for example, would often experience immense difficulties including finding a trial, having to travel great distances for appointments, spending time away from their loved ones for long periods, and needing to take a significant amount of time off work.  The reality for most people was that participating in clinical research was extremely inconvenient. For others, it was simply not possible due to multiple logistical considerations.   

Today, new clinical trial models are bringing people and technology together seamlessly to reduce the burden on participants.  Traditional approaches were redefined during the pandemic, accelerating the shift to telemedicine and digital health services, helping to improve comfort, convenience, and access for patients.  

Clinical trials, at their core, are all about people.  Firstly, and always most importantly, the focus must be on the participant.  Designing a study around the needs of participants is vital for providing a better experience and can contribute directly to the overall success of the research.   

New clinical trial models not only serve to significantly reduce the burden on the participant, but they can be optimised for a people-first approach that benefits their loved ones and care partners, as well as clinicians and sponsors.       

Modernized clinical trials that adopt a people-first approach also have the ability to improve diversity.  They can increase access by removing geographic barriers and provide participants with choice about how (and where) they take part in a clinical trial.  By reducing these roadblocks, we can increase equity in clinical research by making studies available to more people from diverse backgrounds and broader geographical areas. 

Building trials around the participant’s needs  

To enhance the experience, it is critical that the participants and care givers voice is heard and included from the beginning, when the protocol for the clinical trial is being developed.  It is imperative to help the participant balance the demands of a trial with the rest of their life as much as possible. Many of today’s models can ensure that a trial does not consume everything for those involved.  Engaging the participant from the start to understand their needs is often a key ingredient to the success of the study.  

One of the biggest barriers to taking part in clinical research is the financial impact it can have.   A recent survey revealed that potential participants with annual household incomes below $50,000 per year are 27% less likely to participate in clinical trials.(1)  

Particularly at a time when costs are rising, people who are struggling financially simply cannot wait for trial expenses to be reimbursed.  The upfront expenses a participant may incur include travel to and from the study site, meals, childcare, lost time from work and other considerations. For many, the fiscal burden excludes them from taking part in a study or forces them to leave the clinical trial before it is completed.   

A critical differentiator of a people-first approach is that it puts support mechanisms in place at the start. For example, providing participants with debit cards to cover any out-of-pocket expenses incurred when taking part in a trial can immediately alleviate some financial stressors.        

A major consideration for a participant in a clinical trial is the opportunity to receive medications, treatments, or therapies as an alternative for their health care condition, ahead of availability in the marketplace.  Another important factor is that they have the best possible experience while taking part in the trial. Participants must receive an ethical, reliable, caring, people-first experience, and that is reliant on clinical research nurses, study coordinators, and principal investigators; the entire team that works with participants must be trained to the highest standards. 

We have received feedback that participants greatly appreciate it when the nurse assigned to care for them is the primary nurse throughout the schedule of assessments.  It can alleviate the anxiety that some patients feel and often creates a strong connection over the course of the study. 

(1) Visit: jamanetwork.com/journals/jamaoncology/fullarticle/2457394

Kristin Croucher, Vice President of Clinical Operations at Lightship, is a life sciences strategist with two decades of managing a range of teams and implementing high-level, multi-national operations across Africa, USA, Latin America, Europe, Asia and Australia.

David MacMurchy, CEO at Lightship, is a leader in the healthcare sector with over 25 years' experience working for leading organizations in the life sciences industry. In previous roles, he collaborated with life science companies across the US, Europe and China.

People First: Enhancing Participant Experience in Clinical Trials,
Part 1 of a 2

Authored by David MacMurchy, CEO, Lightship

In recent years, we have seen people and technology coming together to deliver advancements in the clinical research enterprise by addressing challenges escalated by the COVID-19 pandemic. 

Long-established operating models have been redefined in the wake of the pandemic. The shift towards telemedicine and digital health services has accelerated, improving comfort, convenience, and access for patients, helping to reduce the burden on medical facilities, and giving valuable time back to clinicians and their staff.  

Although there is a long way to go in addressing and increasing access and equity in clinical trials, virtual-first and hybrid approaches are driving the progress we need to deliver clinical research today with a three-fold impact. 

First, these new models increase access for participants because they remove geographic barriers so people can now be part of a clinical trial regardless of where they live. 

Second, participants now have a choice around not just where, but also how they can take part in the clinical trial. 

And third, by lowering these other barriers, we are increasing equity in clinical research by making clinical trials available to people across more demographics.

Designing flexibility into clinical trial models that provides choice and improves access is vital in building the clinical trial around the needs of the participant. That versatility ensures that the majority of participants can be met where they are, with maximum access, convenience, safety, and comfort. 

 Not only does prioritizing choice in clinical trials ease the burden on the participant – it also has the potential to improve recruitment, retention, and diversity in research studies, driving more successful outcomes for all.  

To optimize choice, we need to have an in-depth understanding of participants’ preferences. When we have spoken to clinical trial participants, the vast majority tell us that they are more likely to take part in a clinical trial if meetings could take place at home or in a mobile research unit (MRU). MRUs have emerged as an alternative site alongside other community-based brick and mortar sites, and outside of traditional settings for clinical studies, like hospitals or medical centers. They provide a ‘third place’ for clinical studies, in addition to a clinic or the home.

Potential participants with annual household incomes below $50,000 per year have been found to be 27% less likely to participate in clinical trials.[1]  Having choices on how and where to participate extends the reach of a clinical study across socio-economic boundaries, as well as geographic ones. 

Offering alternative visit locations and greater flexibility around appointments reduces the travel costs on the participants and can ease or potentially eliminate work and childcare scheduling conflicts. This can make all the difference, particularly for the most vulnerable, who might otherwise be unable or unwilling to participate in a trial. 

 In clinical trials, it is vital to never lose sight of the fact that they are all about people. When we talk about meeting participants ‘where they are’, we are referring to the need to connect with them on an emotional level, as well as a medically focused one. Earning their trust is clearly the most important part of this.

Prioritizing choice can help to reach communities that have a generalized mistrust of doctors and healthcare, with attitudes based on current and historic events. Trust has declined in the last 50 years, resulting in difficult doctor-patient relationships, less patient compliance, and ultimately unrepresentative outcomes. In 1975, 73% of Americans said they had high confidence in medical leadership. According to a Gallup poll in 2018, only 34% felt the same way.[2] 

We can help change that by looking for ways to collaborate across the healthcare industry, continuous community engagement and humility to strengthen trust in medical systems. Demonstrating our commitment to transparency about clinical research goals and outcomes is an essential part of this work.   

For participants in clinical trials today, there are two things that should be considered. Firstly, it is the opportunity to access a clinical trial they may never have known about or been able to fit into their life.

Secondly, it is that they have the best possible experience while taking part in the study. They need to receive a reliable, caring, people-first experience, and that is dependent on clinical research nurses, study coordinators, and principal investigators; the entire team that works with participants being trained to a high standard.

Participants typically appreciate it when the nurse assigned to care for them is the primary nurse throughout the schedule of assessments, with the frequency of visits dictated by the drug or device protocol. Virtual-first and hybrid models can deliver additional oversight and care that provides a consistently high-level experience. Within these models, smartphone apps play an important role in empowering the participant (and in some cases, their care partners) enabling them to navigate the trial, the scheduling of appointments and clinical trial procedures with greater ease.

Across the clinical research enterprise, we are seeing the results of how prioritizing choice is making it easier to participate in studies. Our experience of virtual-first and hybrid trials has shown increases in recruitment and retention. This can be accomplished by expanding access with targeted recruitment in locations outside a specific geographic radius around a trial site.  Mobile nurses are able to go to where the participants are, and not have to rely on recruiting patients solely in close proximity to the site. 

The industry is at the start of this journey, but we are already seeing how new models are increasing access, choice, and equity for participants in clinical studies while scaling efficiencies for pharma companies in the conduct of clinical research.   

Learn more about Lightship here (https://www.lightship.com/solutions/)

David is a leader in the healthcare sector with over 25 years’ experience working for leading organizations in the life sciences industry. He established Lightship’s people-first approach, which was specifically designed to enhance the experience for participants in clinical trials. 

This Opinion Editorial originally appeared in Health Tech World.

[1] JAMA Oncology, 2016 https://jamanetwork.com/journals/jamaoncology/fullarticle/2457394 

[1] Gallup, 2018: https://www.scp-health.com/blog/impactful-strategies-hospitals-can-use-to-improve-community-health-and-win-back-patient-trust/

Prioritizing Choice for Participants to Enhance & Accelerate Clinical Trials

Developing new medications, treatments and therapies is an expensive endeavor with many variables. Approximately 88% of drugs do not ultimately receive FDA approval. The business operations, research and development costs for the 12% that do make it to market can range from less than $1 billion to more than $2 billion per drug. (1) Historically the domain of big pharma, emerging biopharma organizations are making strides, patenting almost two-thirds of new drugs and registering 47% of them in 2018. (2) Driving disruption and innovation at this level is impressive, but smaller to mid-size biotech and pharma companies face particular challenges when it comes to conducting clinical research.

There is a lot at stake, since their success may be dependent on the development of a lone product. Many emerging organizations are operating in the rare disease space, and enrolling studies with a very limited pool of hard-to-locate participants. Forging partnerships with companies that can tailor their services preserves financial resources, streamlines operations, and saves development time that benefits clinical trial participants.

Emerging and mid-size companies in clinical research navigate:

·      Operating constraints not faced by larger companies

·      Conducting clinical research with leaner teams and fewer overall resources

·      Managing stringent budgets in protocol development, enrolling studies with aggressive timelines, and delivering good data efficiently  

·      Integrating decentralized and hybrid approaches for clinical trials, cost effectively

·      Finding providers with a similar cultural mindset and flexible approaches

Emerging and mid-sized biotechs and pharma companies are looking for business relationships with providers that:

·      Are high-touch yet cost-effective

·      Provide effective oversight on clinical operations

·      Have a clear understanding of the sensitivity around project timelines

·      Design and implement nimble approaches

·      Fill any gaps in their infrastructure, when needed

·      Offer a modular approach where companies can select the services they need

The past few years have seen the rapid adoption of virtual-first and decentralized approaches to moving clinical trials forward. Telehealth appointments, which counted for less than 1% of medical appointments before the pandemic (3) are becoming more accepted by patients and participants in clinical trials. Digital health and mobile apps are reducing the burden of participation for clinical trial participants and their care partners. While the impact of these advances cannot be discounted, not all clinical research can be conducted remotely. There are challenges with consistency in staffing across per-patient visits. Emerging and mid-sized companies  benefit most when partners in the clinical research enterprise formulate the best approach, depending on the TA (therapeutic area) and protocol design.

There are approximately 300 million people worldwide impacted by about 7 thousand rare diseases. A disease is classified as “rare” in the United States if it affects less than 200,000 people, and in the European Union, the statistic used is 1 in 2,000. (4) Most rare diseases are genetic or have a genetic component. With non-rare diseases such as diabetes or heart disease, the pool of potential clinical trial participants is large. Companies conducting rare disease research are challenged by very small patient populations, issues with enrollment and providing ease of access to participants who are geographically dispersed. Social media effectively connects patients around the world, but it can still be difficult to reach the target demographic. Clinical trial service providers need to understand what it takes to navigate the complexities of this research space, particularly with respect to timelines, medical technology and budgetary concerns.

Choosing the right partner (or partners) for conducting clinical research starts with a relationship that is built on mutual understanding, clear communication and trust. Providers that can deploy the right array of tactical and strategic support to emerging and mid-sized companies can help pave the path to regulatory approval efficiently, while preserving timelines that benefit participants and sponsors. To learn more about Lightship’s flexible, problem-solving approaches  visit https://www.lightship.com/approach.

(1) https://www.cbo.gov/publication/57126  

(2) https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-changing-landscape-of-research-and-development.pdf?_=1658766297742

(3) https://www.ama-assn.org/practice-management/digital/2022-moving-beyond-telehealth-digitally-enabled-care

(4) https://rarediseases.info.nih.gov/diseases/pages/31/faqs-about-rare-diseases

Supporting Emerging & Midsize Biotechs & Pharma in Clinical Research

Lightship’s Giving Group, comprised of a team of colleagues from different sectors of the company, identify and support organizations on a quarterly basis that align with Lightship’s values of serving others and making an impact. The Giving Group is happy to share that the following organizations were selected for Q2 2022: 

Black Women in Clinical Research – BWICR

Alzheimer’s Society, based in the United Kingdom, provides advice, guidance and support for people with the disease and their loved ones through a variety of programs and services. Out and Equal promotes workplace equality for members of the LGBTQ+ community by partnering with companies to create a culture of belonging for all. Black Women in Clinical Research – BWICR, founded by Danielle Mitchell in 2019, is a network of black women who are interested in a career in clinical research or who are currently working in the industry. BWICR has monthly meetings (in-person and virtual) and other programs to support professional development. 

“We’re excited to have the opportunity to support such strong organizations that are making important contributions to their constituents,” says Lori Llewelyn, Vice President, Quality at Lightship. “One of our core beliefs at Lightship is ‘We believe in people’, and the work of the Giving Group puts that into action.” 

To learn more about the Giving Group, contact giving@lightship.com. 

Lighting the Way to Support Impactful Organizations: Lighship's Giving Group Q2 Report

You are the parent or legal guardian of a child who is participating in pediatric clinical research, studying a medication, treatment, therapy or medical device to treat an illness or condition. While the trial is scheduled to continue, your child’s participation will soon be coming to an end, because they are turning 18 on their next birthday and will no longer be eligible to participate. What should you do if your child is aging out of a clinical trial? 

Before joining a clinical trial, there are multiple steps including signing an informed consent form (ICF). This document outlines possible risks and benefits about the medication, medical procedure, treatment or therapy being studied, and other important information that may impact one’s decision to participate. Children seventeen years old and younger cannot legally sign the ICF. Instead, they take part in the “assent” process, where children and adolescents receive easy-to-understand information about the clinical trial so they can decide to participate – or not (depending upon their age and intellectual capacity). Formal consent is provided by the parent or guardian. (1) During this process, you can ask questions about all aspects of the clinical trial, including potential next steps for when the trial ends. 

Information to address with the PI (Principal Investigator, the physician in charge of the study) and clinical research staff includes: 

·      Will the results of clinical trial be shared with you and your child, and if so, how will they be delivered? 

·      Are there any follow-up studies? 

·      How will the participant’s care be transitioned? 

·      Is it possible to remain in the care of the research site staff? 

·      If the participant has received an investigational medication, treatment, therapy or device that has improved their condition, can they continue to have access to it after the trial? 

·      If they can receive it, will there be any affiliated cost? 

·      If there is a cost, is financial assistance available? 

·      Is it possible to be introduced to other parent(s), caregivers and former participants to learn more about their experience transitioning out of the trial? 

Connecting with patient advocacy organizations as well as the local representative from the pharmaceutical company in your area can be another way to find additional resources. Patient advocacy groups support patients, their families and care partners offering logistical as well as emotional support via meetings, events, and published educational materials. They span all types of physical and mental conditions, from well-studied illnesses such as diabetes to rare diseases. The following nonprofits provide information about specific diseases and navigating health care issues: 

NORD (National Organization for Rare Disorders) 

Pharmaceutical representatives may be able to provide information about corporate-sponsored patient-facing initiatives, including coupon programs and PAPs (patient assistance programs).  

Sabina Kineen is a rare disease patient, caregiver, advocate and rare mother whose daughter aged out of a clinical trial. Sabina shares “We were thrilled that our daughter was able to enroll in a clinical trial for a new treatment for her condition. At the time of enrollment, we knew she would most likely age out prior to completion of the study. Even under typical circumstances, transitioning from pediatric care to adult care can be quite challenging. Doing so while participating in a study may seem more complicated. However, having the right information from the beginning makes things go much more smoothly. Don’t be afraid to ask questions. Use your voice. Your Principal Investigator and Study Coordinator are there to ensure that you and your child are comfortable with the process before moving forward.” 

Transitioning out of a clinical trial does not necessarily mean that treatment and care is going to end, but it is important to understand the ramifications. Asking the right questions, whether during the informed consent process or later on in the trial, helps parents and guardians formulate a strategic plan for the pediatric participants who will soon no longer be considered children in clinical research. Learn how Lightship is increasing access, choice and equity for participants in clinical research here: https://www.lightship.com/patients 

(1)   https://www.cancer.gov/about-cancer/treatment/clinical-trials/patient-safety/childrens-assent 

Time's Up? What To Do If Your Child Is Aging Out of a Clinical Trial

There is an excruciating duality to Alzheimer’s disease: patients may only have flashes of recognition that their mind is deteriorating while caregivers watch their loved one slip away in slow motion. The emotional toll is accompanied by practical healthcare considerations with serious implications. It can become increasingly difficult to bring people suffering from Alzheimer’s to doctor’s appointments due to the mental and physical impacts of the disease. While there are currently no cures for Alzheimer’s, virtual-first and hybrid approaches to clinical research are providing new avenues for clinical trial participation, with studies that meet patients where they are:  at home, a nursing care facility or a “third place”.  With changes in the brain often happening 10 years or more before any symptoms are visible, these different approaches also provide opportunity for younger, at-risk individuals to participate in clinical trials aimed at prevention with additional flexibility. 

Virtual-First & Decentralized Clinical Trials 

A virtual-first or decentralized approach to clinical trials uses digital health tools, such as apps paired to mobile phones and tablets with easily operable digital medical devices, to monitor heart rate, blood pressure and other health targets. Participants can be seen by clinical research nurses in a location of their (or their care partner’s) choosing. Eliminating geographic and logistical burdens can make it easier to participate in clinical research as a health care option.  While this increases diversity and equity in clinical studies, diverse participants are still less likely to meet inclusion and exclusion criteria in clinical trial protocols, usually due to pre-existing conditions. 

“At Lightship, we are focused on providing patients and care partners with as much flexibility as possible, while providing superior clinical trial care,” says Marieke Cajal-Berman, Ph.D., Senior Director, Patient Engagement. “With Alzheimer’s trials, some procedures such as MRIs, do require in-person visits. However, many participants can take part in trials conducted via telemedicine for some doctor visits, or nurses may visit them at home, which reduces the burden of travel to and from a clinic or hospital.” 

Having a “third place” for patients to be seen provides another option for people who may not be comfortable with a home visit. MRCs (mobile research clinics), that are fully functional clinical study facilities, are one such example. They can be driven to meet a participant outside of their home or at another location. These vehicles bring clinical trial opportunities to potential participants in diverse neighborhoods, rural communities, and other underserved populations wherever they are.  

“There are many ways to provide patients and care partners with choice around clinical trial participation,” says Marieke. “Making Alzheimer’s clinical studies more accessible increases the diversity of the participants involved, which helps advance medical science and better outcomes for all.” 

(This article originally appeared in Personal Health by MediaPlanet and in a supplement in USA Today).

Learn more about Lightship at https://www.lightship.com/ 

Virtual-First Clinical Trials & Alzheimer’s: Supporting Patients & Care Partners

Lightship conducted research in the United States and United Kingdom to understand the public's opinions towards clinical trials, telemedicine, healthcare delivery, home health and mobile healthcare. Findings include:

58% of respondents in the US and UK would prefer to receive healthcare at home or in a mobile clinic

83% of respondents in the US and UK over the age of 46 were in favor of being seen at a mobile research unit

30% of respondents in the US and UK who had used telemedicine were happy with their experience because they did not have to travel or spend time in a waiting room

Gain more insights. Receive a copy of the full report by contacting Lightship at mediarelations@lightship.com. 

Thought Leadership Report: Meeting Patients Where They Are; Building Access, Inclusion & Equity in Clinical Research with Virtual-First, In-Clinic and "the Third Place" Approaches

Leveraging H1’s Trial Landscape solution, Lightship will incorporate important diversity data into its clinical trials process, bringing life-changing therapies to a more diverse patient population.

H1 and Lightship Partner to Accelerate Clinical Studies with Diversity, Equity, and Inclusion Data

On May 20th, Lightship colleagues, clinical research professionals and patients globally will be celebrating Clinical Trials Day. But first, let’s take a trip back in time to the sea-faring days of the mid-eighteenth century…

You’re a sailor on the HMS Salisbury, part of the fleet of Britain’s Royal Navy that patrols the English channel. You are feeling decidedly unwell. You’re irritable, fatigued and have severe pain in your legs and joints. Most alarmingly, your gums are bleeding and you bruise easily. You and your crewmates are suffering with scurvy, a deficiency of vitamin C, a common ailment at the time. Fortunately, James Lind, the ship’s surgeon mate, born in Edinburgh and a graduate of the University there, is about to do something very leading-edge for the day.

A pioneer of naval hygiene, Lind is going to conduct what is recognized as the first randomized clinical trial on the twentieth of May, 1747.

Twelve crew were recruited by Lind to consume different treatments, including cider, dilute sulphuric acid, vinegar, sea water, citrus fruits or a paste made of garlic, mustard seed, dried radish root and gum myrrh. The sailors who ate oranges and lemons reported “the most sudden and good visible effects”, according to Lind.

In addition to marking this important milestone, Clinical Trials Day is a time to raise awareness about the importance of clinical research.

“At Lightship, we are providing patients with a choice about where they receive their clinical trial,” says David MacMurchy, CEO. “We are focused on creating access to clinical research for all people by removing geographic and logistical burdens. This scales equity and increases diversity of participation.”

You can learn more about James Lind here and about Lightship’s capabilities here.

(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6235704/)

(https://www.jameslindlibrary.org/articles/who-was-james-lind-and-what-exactly-did-he-achieve/)

On May 20th, we celebrate Clinical Trials Day. But first, let’s take a trip back in time...

Lightship Celebrates Clinical Trials Day

Lightship has a virtual-first and hybrid approach to clinical research. But what exactly does that mean for patients and care partners? All regulations and patient protections remain the same.  

What changes is the increased level of access and convenience.  

“In a virtual-first approach, we are not changing how the clinical trial is conducted, we are changing where it is conducted,” explains Rachael Scott, Chief Commercial Officer, Lightship. “Our staff of clinical research nurses visit patients in their home. Appointments with the Principal Investigator managing the trial are done using telehealth. It is incredibly convenient and saves a lot of time by greatly decreasing, or in some cases, eliminating, travel to and from a physical clinical site, significantly reducing patient and care-giver burden.”  

This increase in access is not limited to home. Lightship nurses can also visit patients at work, or at another location, which we at Lightship call, “the Third Place”. In pediatric clinical trials, nurses can deliver clinical care at the patient’s school, so that students are missing less time out of class when they are part of a clinical trial. 

A variety of digital tools can be paired with apps on mobile phones or tablets to monitor patient health. These can include easily operable blood pressure, heart rate and glucose monitors, to name just a few. 

The hybrid part of the equation enters when certain tests or procedures cannot be conducted in a patient’s home or other location, such as MRIs and CAT scans. In these cases, participants may go to a clinic, hospital or medical office. The benefit of the hybrid model is that clinic visits are minimized, reducing the burden of travel and other logistical considerations, such as coordinating childcare or missing work. 

“This virtual-first and hybrid approach has a three-fold effect,” says David MacMurchy, CEO Lightship. “First, you are increasing access for patients when you remove geographic barriers, because they can now be part of a clinical trial, regardless of where they live. Second, you are providing them with choices around where they can receive the clinical trial. And third, you are increasing equity in clinical research since you are making clinical care readily available to people of all demographics.” 

You can learn more about how Lightship conducts clinical trials here.  

Virtual-First Clinical Trials: Changing Where Clinical Research Happens

Prioritizing patient choice in clinical research means meeting people where they are and breaking down the barriers that prevent underrepresented groups from participating in clinical trials. Samantha Eells, Co-Founder and Kristin Croucher, Vice President Clinical Operations & Delivery are presenting the advantages of “The Third Place: Improving Access, Choice and Equity” at SCOPE Europe on Thursday, April 21, 2022. Their presentation is part of the day’s program on “Hybrid Trials, Diversity & Inclusion, Transparency & Patients Partners to Achieve Truly Patient-Centric Design”. CEO David MacMurchy is chairing the event.

“We all agree that access to clinical trials should be fair for every participant,” says Sam. “The reality is that a large proportion of people in need still don’t have access to clinical studies as a treatment option.”

“To provide choices to patients that deliver better clinical trials, you need to have a comprehensive understanding of participants’ potential preferences, to start with,” says Kristin. “Lightship’s virtual-first and hybrid approach to clinical research means that patients can be seen at home, in clinic, or a third place, such as at work or a mobile unit.”

“Some patients may not be comfortable having someone visit them at home,” says David. “Giving people the choice to be seen in a third place strengthens relationships between participants and clinical research staff, which builds trust.”

Approaching patient recruitment in a holistic way enables providers to increase access to clinical trials and boost retention rates, helping deliver studies that are more diverse and more effective.

Prioritizing patient choice in clinical research means meeting people where they are and breaking down the barriers that prevent underrepresented groups from participating in clinical trials.

Samantha Eells & Kristin Croucher on the “Third Place” in Clinical Trials: SCOPE EU 2022

At the dawn of decentralized trials, the model was perceived as a threat to the site. Is that still the case? How do these models coexist and succeed?

News

Follow us