Scott Gray is the Co-founder and CEO of 

Scott Gray

The average investment in recruiting just one patient for a clinical trial has been 

 to be as much as $6,500. Once patients are successfully enrolled, clinical trial coordinators then face the uphill battle of retaining these patients for the duration of the study. With dropout rates often exceeding 30%, the loss of trial participants is a significant concern for our industry.

Fortunately, hope is not lost—pharmaceutical sponsors and clinical research organizations (CROs) are finding they can improve patient retention rates and bolster trial completion with patient centric trials and patient support services.

Understanding the many barriers preventing patients from trial participation is most essential step to keeping them enrolled. These challenges often include missed work (and subsequent loss of income), complex travel arrangements, time away from home and family, increased childcare needs, and the financial burden of delayed reimbursements. Factors such as the trial duration and a patient's perceived feelings of being valued throughout the trial also impact retention.

Maintaining open and ongoing communication between trial participants, caregivers, and trial staff go a long way in increasing retention rates. Initial, one-on-one discussions help patients anticipate the scope and commitment involved in trial participation while demonstrating the level of support provided throughout the study to overcome potential challenges.

Improving trial outcomes with patient centricity

In recent years, our industry has made a noticeable and advantageous shift towards “patient centricity.” Patient-centric clinical trials improve the patient experience by making trials as comfortable and efficient as possible and removing unnecessary burdens to patients facing a difficult diagnosis. These trials consider the patient's needs from the earliest planning stages, incorporating a patient-first blueprint into the study's design.

In February 2022, the Food and Drug Administration (FDA) released new 

 detailing how drug development teams can implement patient-centric trials. An earlier 

 by The Economist Intelligence Unit found drugs developed with patient-centric processes were:

Nearly 20 percent more likely to launch than drugs developed without a patient-focused approach. This number was consistent across therapeutic areas (neurology, oncology, and rare diseases).

Quicker to recruit 100 participants (4-month time period) compared to other innovation types (6-11 months) and all trials (7 months).

A patient-centric approach makes sense socially, financially, and clinically and is rightfully becoming a standard practice throughout our industry. To improve patient experience, clinical trial teams can assist patients with study logistics, leverage technology to reduce patient visits (i.e., wearable monitors, video appointments, etc.), and establish communication channels to keep patients and trial staff well-connected throughout the entire process. From trial design through trial completion, prioritizing patient needs ensures better outcomes for patients and ultimately brings treatments to market faster.

Initially, when trial teams began using a patient-centric model, they focused on improving the clinical aspects of trials, focusing on providing better patient care. It quickly became apparent that addressing patients' social needs were equally crucial to trial success.

CROs and trial sponsors began asking: How can these studies help patients beyond treatment? Are patients struggling with daily pressures, like finding transportation to and from trial appointments? Are pressures from out-of-pocket expenses causing patients to consider dropping out? The answers to these questions highlighted the need to help patients manage the daily challenges of trial participation.

Today, many clinical trial sponsors look to companies like 

 to manage patient logistics for their trials. Clincierge’s global team of patient coordinators works directly with patients and their caregivers to ensure comfort and safety throughout a trial. Coordinators are local to the patient, ensuring they share a time zone and cultural understanding and providing a high-touch, concierge level of service.

Throughout the duration of a trial, patient care coordinators establish trusting relationships with patients, caregivers, and clinical site staff. Being regionally and culturally aligned from enrollment through the last visit, patients feel they have someone 'in their corner.' This consistency supports better long-term trial retention as patients and caregivers can focus on the patient's treatment, not the logistics involved. It also frees clinical site teams to focus on the data collection and endpoints of the trial and the patient experience during the site visits.

Patient support providers can also alleviate the complexities of multi-country rare disease trials, which often require extensive travel, visas, relocation, language translation, housing, and transport of medically fragile and pediatric patients. Patient coordinators often plan and pre-pay for cross-border travel while navigating the bureaucratic obstacles preventing patients from participating.

In ideal cases, trial sponsors build patient support into the earliest rounds of the trial design, allowing patient coordinators to assist with patient onboarding. This trial model also encourages patient diversity. By communicating with underserved populations and educating them about available compensation and travel reimbursements, patient coordinators assist in enrolling patients who fit trial criteria regardless of their ability to cover participation costs.

By partnering with a patient support services company, clinical trial sponsors ensure higher retention rates while focusing on the needs of the patients involved. Ultimately, patient-centric clinical trials help new therapies get to market faster while supporting the pharmaceutical industry's most significant goal—caring for the health and well-being of patients around the globe.

Case study: Patient support services at work

A review of a multi-year clinical study highlights the impact patient care coordinators have on trial outcomes. The study is researching a new treatment for Duchenne Muscular Dystrophy (DMD), a rare progressive muscle-wasting disease primarily impacting boys.

In rare diseases like DMD, patient populations tend to be small and geographically distributed across the globe. The DMD study spans 35 trial sites in nine countries. Over a five-year period, 18 patient care coordinators have provided support services, including arranging cross-border travel and accommodations for more than 170 trial patients and their caregivers.

These coordinators arrange cross-border transport and accommodation for patients and help them feel comfortable surrounded by new cultures. Speaking the native language of the patient and caregiver and living in the same time zone ensures ongoing communication and personalized support throughout the trial.

Site travel has been provided via airplane, rail, and wheelchair-accessible car service. In total, patient care coordinators booked more than200 airline flights, 250 ground transportation trips, and 530 hotel reservations.

Over 1,300 reimbursements have been distributed to participants after site visits.

Patient carecoordinators have learned the intricacies of DMD to anticipate this patient population's needs and travel preferences. DMD patients often require wheelchairs, so they need ADA-compliant hotel rooms, accessible bathrooms, and living spaces allowing for wheelchair movement.

Likewise, because chewing and swallowing are challenges for DMD patients, many require specific foods and strategically planned mealtimes. Patient coordinators ensure safe and fortified foods are available, allowing patients to adhere to strict dietary guidelines. As patients' medical needs have changed throughout the trial, coordinators continue to tailor logistics to accommodate them.

Removing the emotional, financial, and logistical burdens of clinical trial participation allows patients, caregivers, and trial teams to focus on life-changing treatments. Although this trial is still underway, it is progressing on schedule and within budget, due in part to a patient retention rate that surpasses industry benchmarks.

 is the founder and CEO of Clincierge. He was featured on a previous episode of the Applied Clinical Trials podcast. Listen 

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Sponsors can ensure higher retention by partnering with patient support services.

The Role of Support Services in Patient Retention 

 by the University of Texas MD Anderson Cancer Center, nearly half of all patients enrolled in early-phase clinical trials face monthly out-of-pocket costs of at least $1,000.

As clinical trial professionals, we understand the costs of extended travel, missed work, and out-of-pocket expenses often 

 trial participation. However, a patient's income level should not determine access to potentially life-saving treatments via clinical trials.

These upfront healthcare-related expenses create a significant barrier to trial participation for low-income populations, further complicating our industry's challenges to adequately fill trials with diverse patient populations. However, recent changes in legislation may offer relief for those in need.

In Dec. 2020, Congress passed a $2.3 trillion Omnibus Appropriations and Coronavirus Relief Package. This bill included a compelling directive to create equal and increased access to clinical trials for the more than 

enrolled in Medicaid. Medicaid is a healthcare program funded by both the federal government and individual states, and it covers low-income children, pregnant women, elderly adults, and those with disabilities.

On Jan. 1, 2022, coverage of all "routine costs" associated with clinical trial participation became guaranteed for Medicaid beneficiaries through the Clinical Treatment Act.

A watershed moment for equality in United States healthcare, this new law aims to create access to clinical trials for marginalized communities and minority patient populations who have been historically under-represented.

For clinical trial sponsors and clinical research organizations (CROs), improving access for Medicaid participants means new opportunities to study drugs among more diverse patient populations, the potential to bolster trial enrollments, and improved equity in delivering life-saving treatments to patients.

A brief history of clinical trial coverage and us legislation

In 2000, a federal mandate required Medicare to 

 routine costs associated with clinical trial participation. Medicare is a federally funded healthcare insurance program covering Americans aged 65 and over, regardless of income. Due to this mandate, participation in clinical trials in patients over 65 increased. Ten years later, the 2010 Affordable Care Act (ACA) required all private insurers and health plans to provide the same coverage for clinical trial participants.

Yet Medicaid, the government assistance program providing health coverage to Americans of all ages, saw no federal mandate. Prior to Jan. 1, 2022, Medicaid did not guarantee coverage of routine costs for beneficiaries participating in clinical trials. Coverage determinations were at the discretion of individual US states, with only 16 states mandating coverage.

Medicaid's decentralized system resulted in years of inconsistencies and limited access to state-of-the-art treatments for millions of low-income and minority Americans.

 of Americans currently utilize Medicaid, with varying participation numbers among states. Sixty-one percent of Medicaid beneficiaries identify as Black, Hispanic, Asian American, or another non-white race or ethnicity.

 covers routine costs for patient care resulting from participation in qualifying clinical trials. These costs include fees for hospital stays, doctor and lab visits, diagnostic testing, and other medical services routinely covered if the patient was not enrolled in a clinical trial. The act aims to expand diversity in clinical trials and create increased access to life-saving therapies for low-income and minority populations.

Closing the diversity gap within clinical trials

Historically, minority and low-income populations are underrepresented in clinical research. As a result, trials often fail to collect evidence-based data on diverse patient populations that would benefit from new medications.

To date, clinical trial participants are predominantly white men, a demographic which often has a greater ability to take time away from work and family and pay the required out-of-pocket costs for travel to and from trial sites. White patients in the United States typically have the resources, language skills, and capabilities to research relevant clinical trials and often have more support when committing to study participation.

According to the American Society of Clinical Oncology (ASCO),white patients are nearly twice as likely as Black patients and three times as likely as Hispanic patients to enroll in cancer clinical trials. A 14-year 

 of minorities and women enrolled in oncology trials found:

of trial participants are non-Hispanic White (percent of US population 60.7%)

of trial participants are African American/Black (percent of US population 13.4%)

of trial participants are Hispanic or Latino (percent of US population 18.1%)

When compared against US population data, less than half of the African American/Black population and one-sixth of the Hispanic or Latino population are represented in clinical trials. This disparity in participation is not limited to clinical trials within the United States. One 

 investigating trial data from 29 countries over the past 21 years revealed that 86% of participants were white.

Drug safety and efficacy cannot be equitably studied among disparate demographic groups without diverse enrollment.

Improving clinical trial access for Medicaid participants, 60% of whom are non-White, carries implications beyond equitable access. More diverse trial populations will enhance the data collected by trial sponsors and CROs, improving the accuracy of the research conducted. Therefore, demographically inclusive research can help drug makers address therapeutic disparities before regulatory approval and broader market release.

Disadvantaged populations and the healthcare system

The Clinical Treatment Act seeks to level the playing field by giving low-income Americans the same benefits Medicare participants and privately insured Americans received years ago. The question is, will this be enough to correct the course of care?

Minority patients are less likely to be referred to clinical trials by their doctors and less likely to participate even when made aware of trials. Logistics such as securing childcare and traveling long distances to trial sites are common factors that hinder participation. Even when expenses are reimbursed, the cost of clinical trial participation is often prohibitive. Patients in households making less than $50,000 per year are 27% less 

 populations are more likely to have an illness requiring medical attention and are more likely to have 

 medical conditions. Stringent pre-qualification criteria for trial participation often exclude patients with pre-existing secondary conditions. However, the new Medicaid legislation does not cover screening visits for prospective patients, a critical first step towards trial participation.

Overcoming the barriers facing minorities and people of color is a significant challenge. Pharmaceutical companies and CROs shoulder the responsibility to actively recruit and build trust among minority populations. Only when we intentionally address these challenges will clinical trial diversity expand to reach levels that will improve drug safety and efficacy for all demographics.

Strategic site placements should be considered when designing clinical trial protocols to ease the burden of participation. Setting up trial sites within neighborhoods of minority patients and offering weekend and evening hours for trial recruitment events are two simple ways to better accommodate patients of various demographic groups.

Establishing a trusted presence and communicating with underserved patients in their communities is a vital step in generating interest in clinical trials. Pharmaceutical companies should build relationships with community leaders to help educate the community about the availability and importance of clinical trials and explain the financial support available to participants.

Partnering with a patient support services company experienced in working with diverse patient populations can help trial participants overcome barriers throughout the duration of a clinical trial and improve participant retention. Not surprisingly, trial sponsors providing strong patient support build trust with trial participants from beginning to end.

Additional ways to improve clinical trial diversity

Successful outcomes of demographically inclusive trials during COVID-19 have shown that clinical trial diversity can increase. The new Medicaid mandate is another step in the right direction. In addition, several leading pharmaceutical companies have recently implemented global initiatives focused on diversity and inclusion. The pharmaceutical industry continues to make strides to increase clinical trial diversity, yet our work continues.

Statistics show that most clinical trials are not successful; nearly 

, and 20% are delayed six months or more. The reasons are complex, but chief among them: 85% of clinical trials cannot retain enough patients, with more than two-thirds of trial sites failing to meet targeted patient enrollment. Improving access to life-saving clinical trials is vital from commercial and ethical perspectives.

Addressing the financial challenges facing patients can have the most significant impact in improving trial participation and retention. Supporting underserved populations through assistance with travel stipends, prepaid travel arrangements, and timely reimbursements for expenses can alleviate the pressure patients and their caregivers feel about paying upfront trial costs.

An opportunity to enhance patient equality

The Clinical Treatment Act is a significant step forward to help create increased and equitable access to clinical trials for millions of Americans. It is an opportunity for our industry to deepen trust and engagement with marginalized communities and historically under-represented patient populations. We must continue to educate providers and patients about these new eligibility and reimbursement programs, ensuring equitable access and care to all.

There is no going backward when facing diversity, equity, and social justice issues. Healthcare must learn from its past and enhance clinical trial diversity to reflect the populations we serve.

High upfront patient costs limit access to low-income populations.

Medicaid Coverage of "Routine Costs" for Clinical Trials

It is not an exaggeration to say the pandemic has impacted operations in nearly every sector and industry. For many, it has meant learning to support a remote workforce or offering services and products from behind a screen. For those of us in life sciences, it has increased the prevalence of decentralized clinical trials.

Remote and mobile technologies have made it possible to continue clinical research and prevent the interruption or cancellation of drug development programs despite the emergence of social distancing and travel restrictions. An 

 found 76% of survey respondents have recently accelerated their adoption of decentralized clinical trial methods.

Now that we have been forced to make room for new digital processes, there should be no turning back. The industry’s flexibility combined with rapid technology advancements have sped up patient enrollment, enabled access to real-time patient data, reduced trial timelines, and most importantly, helped keep patients and employees safe. Decentralized trials are the way of the future—yet it would be ill-advised to think of them as a one-size-fits-all solution.

While the pandemic increased the industry’s acceptance of decentralized protocols, moving to an entirely virtual model without in-person interaction is unrealistic. According to 

 completely virtual trials will remain limited. More likely, pharmaceutical companies, contract research organizations (CROs), and other groups will adopt one or two elements of decentralization in trial design.

This sort of hybrid approach allows researchers to take advantage of the benefits of decentralization while ensuring ethical recruitment practices and successful trial outcomes. For example, a trial protocol may require initial in-person site visits prior to patient enrollment and then leverage remote tools to maintain communication and data collection.

Hybrid protocols are highly beneficial for trials involving rare and ultra-rare diseases, which often require patients to receive specialized treatments at designated sites that do not lend themselves to decentralization. Offering routine lab tests and follow-up appointments at local healthcare facilities or through telehealth reduces the burden of participation for both patients and their caregivers, who are also grappling with the medical implications of their diseases and the typical stressors of daily life.

Many patients with rare diseases are also immunocompromised, and the pandemic has only increased their reluctance to rely on mass transit and air travel. However, they are open to alternative arrangements, such as reimbursements for car rentals or mileage and door-to-door ground transportation provided by professional, vaccinated drivers. Some are willing to consider temporary relocation to reduce their time on the road and potential exposure. In one unique case, the most economical solution involved chartering a private plane so a patient with a rare form of cancer could complete her final site visit.

These non-technical solutions share one thing in common: they demonstrate the same creativity and adaptability that has allowed the industry to embrace decentralized trials during the pandemic. Whatever the circumstances may be, clinical researchers must be prepared to accommodate patient needs and remember that technology can be both a blessing and a curse.

For some patients and caregivers, telehealth appointments ease financial constraints by reducing or eliminating the need to take time off work. However, they may also inadvertently deter patients without reliable access to the internet. Not only does patient diversity promote health equity, but it also allows researchers to identify the effects of treatment across demographics and increases the likelihood of regulatory approval from groups like the United States Food and Drug Administration (FDA). Whenever we integrate digital tools into clinical trials, we must remain cognizant of their disadvantages, including their potential impact on historically underserved populations.

According to research from Clinical Leader, 85% of clinical trials do not enroll enough patients, while up to 30% of patients drop out during the course of a clinical trial.

 When the burden of participation seems too great to bear, recruitment and retention rates suffer, increasing trial costs and delaying commercialization.

On the other hand, investing in patient support helps trial sponsors and CROs anticipate and overcome the medical, emotional, financial, and technological obstacles that could make it difficult for patients to participate in their studies.When trial participation calls for it, patient coordinators can work one-on-one with patients and their caregivers to arrange travel and accommodations, facilitate reimbursements and stipends, and more. As patient coordinators earn the trust of patients and caregivers, they build relationships that increase the likelihood that a patient will continue participating through the duration of a trial.

Ultimately, the recent uptick in decentralized trials simply illustrates “patient centricity”—a flexible approach born out of necessity amidst unique circumstances. The future of clinical trials lies not just in technology adoption and remote patient engagement but in our collective ability and willingness to put patient needs at the center of trial design.Patient support services are a natural extension of this concept, offering personalized, empathetic solutions that encourage trial participation and improve trial performance.

Oracle. Survey: COVID-19 the Tipping Point for Decentralized Clinical Trials. November 18, 2020. Read at: 

Survey: COVID-19 the Tipping Point for Decentralized Clinical Trials (oracle.com)

McKinsey & Company. No place like home? Stepping up the decentralization of clinical trials. June 10, 2021, Read at: 

Stepping up the decentralization of clinical trials | McKinsey

Clinical Leader. Considerations for Improving Patient Recruitment into Clinical Trials. Read at: 

Considerations For Improving Patient Recruitment into Clinical Trials (clinicalleader.com)

Now that the industry has been forced to make room for new digital processes, there should be no turning back. 

Scott Gray

Articles

The Role of Support Services in Patient Retention

Medicaid Coverage of "Routine Costs" for Clinical Trials

COVID-19 and the Changing Landscape of Clinical Trials