Dedicated participation is an essential aspect of a successful clinical trial. After spending time and money to enroll trial participants, it is important to address the barriers they may face while participating in order to increase study compliance and reduce dropout rates.
Misconceptions, cost and other challenging logistics may prevent a participant from attending a study visit, following study requirements, or communicating with clinical research site staff. When designing your trial, keep these four barriers in mind in order to prevent participant dropout and compliance errors before they threaten the success of your trial:
Barrier #1 Misconceptions:
To a participant, the clinical trial process is full of unknowns. To provide the best experience possible and encourage quality participation, it is important to address concerns and pre-conceived perceptions your enrolled participants may have when entering a clinical trial. Concerns could include fear of being a “guinea pig”, their odds of receiving a placebo, a loss of autonomy, or anxiety of unknown side effects.
It is important you address these concerns early in your interactions with the participant. Let them know they are not alone in these fears, and communicate why each aspect of the trial is important. You should also reiterate the benefits of participation, like gaining access to expert medical care, learning more about their condition, and playing an active role in their own health care.
Barrier #2 Distrust:
With misconceptions comes distrust. It is essential you understand the history of distrust that surrounds the medical field, particularly when dealing with minority populations.
Recognize that not all barriers are the same or equally prevalent for every participant. Being transparent with the participant about your actions is key because it will identify and explain the study motives. Other ways you can gain trust are to break down any communication barriers, like language or technological literacy. For example, if you want to reach a particular demographic, be sure you speak the language affiliated with that demographic, or communicate in ways that will be best received with the age group that is participating in your clinical trial.
Barrier #3 Logistics:
When designing and implementing a clinical trial, practicality should always be top of mind. In addition to analyzing achievability for your site staff, be sure to evaluate the trial design from the participant’s perspective. Your trial participants have busy lives, and the logistics of participating can keep them from making your trial a priority. Common logistical barriers include the inability to take off work, transportation to and from the research site, how often they are expected to be present, and how far they have to travel. If they have children or rely on caregivers, it can complicate their ability to participate. Logistics are a part of life, and by understanding all the elements involved, you can make feasible choices when deciding what is best for your trial.
When designing your trial, consider what is required of the participant. Understand the barriers involved and try to accommodate them as much as possible. Consider extending the hours your site is open so your subjects don’t have to take off work, provide an area for child care so that they can bring their children along, offer home visits, and be sure to include families and caregivers in conversations about the trial from the start.
Barrier #4 Cost:
In order to combat logistical barriers, many participants will invest their own money to participate in a trial. If your participants encounter delays in the payment process, they may be forced to wait for reimbursement for up to weeks at a time. With this prolonged and slow payment model, participants could be on their next study visit before ever receiving payment for their previous visit. This delay could cause the subject to feel undervalued or that the trial is unorganized, which could spark decrease in compliance and participation.
Just as your subjects need a variety of accommodations for logistical planning, they may also require a diverse amount of options when it comes to payment preference. Giving your participants a choice on how they wish to be paid increases your site’s dedication to patient centricity, which increases the likelihood of a positive clinical trial experience. Tools like Forte’s Participant Payments offer a variety of payment options that not only decrease your site’s administrative burden, but also provide efficient and diverse payment plans for participants.
Reducing these barriers to participation in a clinical trial can lead to more reliable study data, make your site more patient-centric and provide an overall better participant experience. If you anticipate these barriers in your trial design, you can provide reassuring messaging, establish participant expectations and encourage meaningful collaboration. These efforts will not only save your site time and money, but your positive participant experience will help you achieve future success.