Patient recruitment and retention remain the most persistent challenge of clinical research. In spite of major industry efforts focused on exploring patient motivations, alleviating barriers to participation, and improving the overall patient experience, patient accrual is at an all-time low.
A growing body of research conducted by industry groups such as CISCRP and IQVIA suggests that patients are increasingly knowledgeable about and interested in clinical research, a trend accelerated by the rapid industry response to the COVID-19 public health crisis. However, concerns about time and logistics still represent some of the most common impediments to expanded trial participation.
Research sites increasingly employ many efforts centered around removing logistical and cultural barriers. These include transportation assistance, expanded clinic hours to accommodate participants outside of normal business hours, and language translation assistance to help expand participation to patient populations who traditionally have not participated in research. Compensation is another tool that helps offset the financial burden of participation, but it’s often a contentious topic.
However, there are many positive signs that traditional attitudes toward patient compensation are shifting. A recent article in Stat suggested that higher patient compensation — beyond nominal amounts — can help expand participation willingness among racial and ethnic groups traditionally underrepresented in research. It cited a report authored by a National Academies of Sciences, Engineering, and Medicine committee, which not only called for adequate compensation from sponsors but explicit guidance from regulators on equitable compensation, among 15 other recommendations to improve the representation of women and underrepresented minorities in clinical trials.
In a recent qualitative interview conducted by Alcanza, one prospective participant offered a typical sentiment about the challenges of a research commitment: “My schedule’s always changing because I work in the ER, so having one day where I have to make sure that I’m blocked off on that day, that can be a little hard.”
Another prospective participant in the research group shared another common challenge: “The only concern I would have would be the distance… We live in the mountains, so if I had to go to [the site], that’s an hour and 45-minute drive each time [to get] there. So that’s three hours out of my day. That’s wear and tear on the vehicle. That’s wear and tear on the person who’s doing it.”
While explicit guidance for determining appropriate stipend amounts is lacking, key considerations include general study motivations from the relevant patient population, access to standard-of-care treatment, and the burden of participation based on the frequency, duration, and nature of the study visit. Do the study visits involve invasive or uncomfortable procedures, overnight visits, or other inconveniences? Any combination of these circumstances may warrant higher stipends.
“Stipends may not have an equal impact or perceived value across all participants, but they do help bridge the gap across patients who have different barriers to research, whether it’s related to financial, logistical or other reasons” – Carlos Orantes, CEO, Alcanza Clinical Research
Prospective Participants
Before a patient enrolls in a clinical trial, there is a growing recognition of the arduous effort and emotional toll required to navigate the trial-finding process, proceed through multiple screening steps, and determine if one meets eligibility criteria. While the use of patient stipends in study visits has long raised questions about the potential for undue influence and the commercialization of research, the case for fair patient compensation continues to gain momentum, not just for participation but in the pre-screening setting as well. This pre-screening process—the activities leading up to the informed consent process—represents a significant opportunity for improvement in generating study interest and, ultimately, potential enrollment from prospective participants.
Outside the scope of specific protocol requirements, the pre-screening process requires generic informed consent to collect personal data, biometrics, and the performance of specified assessments. It also allows for, like other informed consents, the potential of a stipend. While such a stipend will provide fair compensation for the time, travel, and other burdens of the participant, it also provides a benefit rarely discussed: the assurance that compensation will be provided if a patient keeps an appointment—one with chancy outcomes for the patient due to the uncertainty of eligibility for an available study.
Why is this important? In a scenario where someone works full-time and receives a research opportunity from a site that keeps the same hours as many employers, the real cost of visiting the site to perhaps qualify for a study is high, and it is important that a patient knows some level of compensation exists upon their visit. This message can be communicated by site staff during initial phone calls or in advertising materials. From a regulatory perspective, this is more than acceptable. The FDA describes stipends as not only fair compensation but as a recruitment incentive. In our scenario, the potential participant can attend the appointment with greater confidence that they will not have to incur extra costs to do so. After all, the site is often making an arbitrary decision about when to bring in a patient according to varying levels of confidence in his or her eligibility—a patient should not have to bear the burden of this decision-making process.
In contrast to payment for participation, FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence. – FDA Guidance for Institutional Review Boards and Clinical Investigators, January 2018
In the pre-screening setting, requiring an on-site visit (before fully determining eligibility) is often overlooked as an opportunity to provide compensation to offset transportation costs, opportunity costs associated with missed work, or other obligations. Determining the right amount involves alignment among IRBs, sites, and patients.
Clinical research is wholly dependent on the efforts of patient volunteers. As clinical trial complexity continues to grow and enrollment rates decline, the research community must continually adapt to the needs and preferences of patients to advance the pipeline, provide research opportunities to relevant patient populations and use available tools to promote health equity. Rethinking the utilization of pre-screening stipends is a good place to address future recruitment efforts by extending the ongoing patient stipend conversation.
Look for additional articles on this and related topics as Alcanza explores new ways to expand research participation and reach new patient populations.
Author: Matthew Maxwell, Chief Marketing Officer
