Clinical trial diversity - a Q&A with Clincierge

OSP: ​Clincierge works with Clinical Research Organizations (CROs) and trial sponsors to offer patient logistics services throughout the duration of a clinical trial. What do these services look like, and why are they necessary?​

Patient recruitment and retention are the two most pressing issues in the clinical trial space. Two-thirds of clinical trials fail to enroll enough patients to conduct the study effectively, and 85% of trials fail to retain enough patients through completion. Even after patients are successfully enrolled, clinical trial coordinators face an uphill battle in retaining patients for the duration of the study; dropout rates typically exceed 30%.

Unfortunately, various emotional, financial, and logistical barriers, like geographic location and travel-related costs, often prevent patients from enrolling in trials and accessing life-changing treatments. An independent study from Clincierge examined the patient experience in rare disease clinical trials and found the majority of patients (87%) said participating in a trial was stressful for themselves or their families.

Clincierge helps CROs attract and retain participants with personalized concierge services, local coordinators, and pre-paid and preplanned travel arrangements. Clincierge Coordinators collaborate directly with patients and their caregivers to ensure comfort and safety throughout a trial. Coordinators are in the same time zone as the patient, providing a high-touch, concierge level of service and ensuring a cultural understanding.

OSP: ​The topic of diversity in clinical trials has gained recent attention due to ​the FDA announcing​ that they’ll require researchers and companies seeking approval for late-stage clinical trials to submit a diversity plan for participants. Historically, why has patient diversity been an issue?​

Historically, the vast majority of clinical trial participants have been white males, the demographic who could afford time off from work and away from family, as well as pay out-of-pocket expenses related to the travel necessary to and from clinical research sites. White patients in the United States typically have more resources, language skills, and research tools available to assist in finding clinical trials that could benefit them and a greater support system should they choose to participate.

On the other hand, minority populations are less likely to be referred to a clinical trial and less likely to participate once aware of trial options, resulting from barriers like finding childcare, making a long commute, or general distrust in the pharmaceutical industry. In the U.S., African Americans comprise 13.4% of the population but only 5% of clinical trial participants. The disparity is even worse for the Hispanic or Latino population; they make up 18.1% of the U.S. population and only 1% of trial participants. Asian Americans account for 6% of the population and only 1% in clinical trials, and two-thirds of clinical trials lack any Native American participation.

Arguably the most significant barrier for minority populations is the costs associated with trial participation. Participants face expenses like lost wages from taking time off work, costs incurred when traveling to and from the trial site, lodging and meal expenses, and other incidental charges that come with participation. Even with reimbursement for travel and meals, the additional costs of participation are difficult to overcome. Consider that patients are 27% less likely to participate in clinical trials if they make less than $50,000 annually. The median income for Black households was $40,000 in 2017, while non-Hispanic white Americans reported making an average of $68,000.

OSP:  ​What does diversity look like to you?​

While ethnic and racial diversity should be top of mind for trial sponsors and CROs, many other kinds of diversity should also be considered.

Gender: ​Until recently, medicines, vaccines, and other treatment options were mainly evaluated on men. A recent study published in Contemporary Clinical Trials found that women were underrepresented in clinical trials, which may be contributing to health inequity.

Age: Elderly participants are often omitted from clinical trials, making it difficult for physicians to determine how a given treatment or medication may affect their older patients. 

Geographic location: Because environmental factors have an impact on quality of life and overall health, clinical trials should include participants from diverse geographic areas.

Education level & socioeconomic status: When individuals in lower socioeconomic brackets are excluded from trial participation, researchers do not fully understand how treatments affect underrepresented cross-sections of society.

OSP: ​Why do you think a diverse patient population is necessary?​

The disparities among clinical trial participants are incredibly concerning. Diversity is scientifically crucial to understanding how a new drug or therapy affects patients of varying ages, genders, and ethnic backgrounds. Reactions to many new treatments differ depending on the individual’s genetic makeup. For example, African Americans react differently to certain blood thinners and asthma medications than white populations.

Proportional representation in clinical trials helps researchers and medical professionals accurately understand how or if a drug will affect a particular demographic group negatively or differently. More investigation can then define or address the issue before the therapy receives approval and enters the market. Representation is essential because once a drug becomes commercially available, access will not be restricted to specific demographics; thus, a clear understanding of each demographic’s reaction is imperative before​ going to market.

Diversity impacts industry stakeholders of all sizes, as pharmaceutical giant Pfizer acknowledges that patients from different backgrounds respond differently to the same drugs and therapies.

OSP: ​What are some of the strategies CROs and trial sponsors can utilize to recruit and retain more diverse patients?​

To achieve diversity goals, we first need to directly address the challenges of underrepresented populations in clinical trial participation. Many of these barriers could be mitigated through improved strategic communication with targeted populations.

Educating unique demographic groups on the importance of trial participation and the potential benefits for participants can go a long way in increasing enrollment. For instance, ensuring these groups are aware of the compensation and travel stipends available can sway patients to participate. In the U.S., this might include discussing the Ensuring Access Act,​ which deducts the first $2,000 a patient receives for clinical trial participation from federal benefit eligibility determinations and aims to remove some of the financial barriers lower-income families experience.

Beyond this discussion, studies should be designed with additional resources and communications to make trial participation less burdensome. For example, choosing payment or reimbursement methods that best serve a particular population and partnering with companies that manage patient logistics and expense prepayment can significantly reduce participation barriers and improve trial recruitment and retention rates.

By providing direct one-on-one concierge-level support to patients from enrollment through the completion of the clinical trial, the emotional, financial, and logistical barriers to participation will be significantly eased. When possible, increasing site locations in communities with high numbers of underrepresented populations and holding recruitment events during weekend and evening hours can also make trials more accessible.

All-in-all, adequate representation in clinical trials is achievable, but it is up to the medical community to invest in the tools and resources necessary to make this a reality.