Streamlining Clinical Trials: Mitigation and Management

Scott Gray;

Streamlining Clinical Trials: Mitigation and Management

November 16, 2023

Scott Gray

Feature

Article

Applied Clinical TrialsApplied Clinical Trials-11-01-2023

Volume 32

Issue 11

How service providers are helping to accelerate drug development.

Scott Gray, CEO, Clincierge

The process of developing life-altering treatments for patients in need is a complex endeavor. Clinical trials, the essential gateway to medical innovations and drug approvals, are often plagued by challenges that prevent successful completion. It is common for patient enrollment issues to halt a trial before it even starts. According to a report by Biopharma Dive, 85% of all clinical trials fail to recruit enough patients, while 80% are delayed due to other recruitment problems, such as patients who are too sick to participate.¹

Even when a trial achieves successful recruitment and enrollment numbers, a challenging path toward study completion still lies ahead. Participation issues are not exclusive to the enrollment phase alone; they permeate every stage of the trial process. Approximately 30% of patients drop out before the study is complete.² This low retention rate places a financial burden on pharmaceutical sponsors and contract research organizations (CROs), slowing the speed of bringing new treatments to market.

This article delves deeper into the challenges faced and explores how service providers are positioned to revolutionize the landscape, leading toward increasingly efficient and more patient-focused trials.

Understanding the drivers of recruitment and retention issues

Clinical trials serve as a vital lifeline for patients across the globe, offering hope to those suffering from debilitating illnesses lacking effective treatment options. However, recruitment and retention remain complex issues for trial sponsors and CROs. Currently, more than 300,000 clinical trials worldwide are searching for 40 million participants, one factor contributing to the rising costs of clinical research.³

In theory, trial participation may seem appealing, but in reality, patients experience various logistical, financial, and emotional burdens that can negatively impact participant recruitment and retention rates.

Logistical concerns

Despite the US providing over two-thirds of global trial participants, recent statistics reveal that only 32% of registered trials are exclusively conducted within the nation’s borders.⁴ This type of trial design results in many studies requiring some kind of travel, creating an additional layer of complexity. Participants must consider logistics such as securing flights, booking hotel accommodations and ground transportation, and even more demanding logistics such as passport and visa services or long-term stays abroad with entire families. This travel burden is often in addition to navigating differences in language and culture. These complex planning and logistical arrangements add a layer of difficulty to the patient’s medical needs, often making participation seem impossible.

Financial burdens

Cross-border and local travel requirements can often lead to severe financial burdens for clinical trial participants, as the out-of-pocket costs associated with study participation can add up quickly for the patients and their caregivers. Incidental charges such as transportation to and from the study site (including air, rail, and ground transportation), meal expenses, and additional internet or cellular data charges while overseas can often seem overwhelming to an individual struggling with a severe disease. Even if these expenses are reimbursed, patients may not be in the position to make the initial payments necessary to begin the trial process.

It is also essential to account for the income lost due to time off work. Trials can extend over several months or years, and many individuals are unable or unwilling to forgo their earnings for such a duration. When faced with extreme financial challenges, many patients opt out of participation in clinical studies.

Emotional barriers

The idea of undergoing unproven treatments, facing potential adverse effects, and uncertain outcomes can trigger fear and concern in prospective trial participants. An independent study from Clincierge found most patients said participating in a trial was stressful for themselves or their families.⁵ Over 80% of patients reported that despite feeling excitement related to participation, they also had feelings of anxiety, uncertainty, and frustration. These complex emotions are often rooted in the overarching challenge of managing the trial process alongside their ongoing medical needs.

As clinical site staff and researchers concentrate on the medical and scientific aspects of the trial, the responsibility of managing the tasks mentioned is frequently placed on patients and their caregivers. Thus, the hesitancy of a patient to commit to clinical trial participation is not unreasonable.

The economic and human impact of trial disruptions

The central goal of clinical trials is to develop effective treatments that enhance the quality of life for patients suffering from chronic illness. In many instances, researchers’ primary aim is to eradicate a disease. Nonetheless, the return on investment remains a pivotal factor for trial sponsors and CROs. Losing a single patient during a trial means giving up crucial data and extending timelines, often resulting in significant financial repercussions to the sponsor and CRO. These costs are exacerbated in studies involving rare diseases, where the pool of qualified participants is significantly smaller.

Recruitment and retention problems are cumulative and often result in trial delays. Delays negatively impact study costs and future sales.

While financial losses are often top of mind for trial sponsors and CROs, it is also imperative to recognize the human impact of inefficient trials. A substantial portion of a drug’s ultimate success can be attributed to the contributions of trial participants, as without their involvement, novel treatments would not achieve widespread commercialization. This idea compels us to consider a fundamental question:

If clinical trials hinge on the ability to engage and retain patients throughout a study, how can we proactively mitigate participation risks and strengthen trial performance? It is worth exploring how service providers can play a role in addressing this challenge.

The role of service providers

Sponsors and CROs rely on various external service providers to support their research and allow for better trial management. While data services and technology solutions are often the first thing these companies prioritize, these initiatives do not directly address the challenge of patient engagement and high drop-out rates; however, a transformative shift is occurring. Dedicated patient support services in the form of a patient concierge are a positive, disruptive change in the industry.

Much like a hotel concierge, a patient concierge manages all logistics involved in trial participation. Having a concierge level of support makes a trial much less intimidating for patients, their caregivers, and their families. These services include:

Itinerary planning (flight and rail tickets, hotel accommodations, ground transportation)
Reimbursements for meals, incidentals, mileage, tolls, and parking
Translation services
Visa and passport assistance
Long-term housing and relocation services

Apart from overseeing the intricacies of trial coordination, the patient concierge provides consistent support for patients and caregivers from study enrollment through completion. When surveyed by Clincierge,⁵ 95% of patients and 98% of caregivers said having a single point-of-contact to assist them in the trial was crucial. Ideally, these coordinators are local to the patient, live in their time zone, speak their native language, and understand their local nuances, as local coordinators are better equipped to address unforeseen circumstances impacting the patient’s region.

With the assistance of service providers such as patient concierge companies, the path to expedited, patient-centric, and efficient clinical trials become increasingly promising.

Scott Gray, CEO, Clincierge