Why Some Patients Abandon Clinical Trials Prematurely

So, your patient recruitment marketing campaigns were a success. Check! You were smart to design a dedicated clinical trial website to broadcast your study and build a physician awareness campaign to drive organic patient enrollment. Check!

As a result, you’ve met your patient pool goals with an eye on diversity and sites throughout the world are treating patient’s week after week. Everything seems to be on track and running smoothly. Suddenly you start receiving news of a few dropouts. Okay, not a huge deal, this is to be expected, right? Then it happens. You start to see double-digit dropouts throughout the world missing appointment check-ins and formally asking to withdraw from the study. What’s going on!?

As clinical research studies become increasingly complex and time-consuming, patient retention becomes a top priority for the key stakeholders in any clinical trial. In fact, patient attrition is one of the main reasons why studies fail to reach their endpoint, leading to potentially costly delays and abandoned trials altogether. To meet the necessary patient retention goals, it’s important to understand the main reasons why patients leave clinical trials before they conclude.

Patient retention is paramount to the success of any clinical trial. Subjects dropping out can result in costly delays, data errors and put your entire trial at risk. The average dropout rate is 30%. It is critical to keep trial participants enrolled and not abandon clinical trials prematurely.

Trial AMPlify, a leader in clinical trial patient recruitment, explores the Top Reasons why patients opt out and offers ways you can ensure patients stick around to the end?

1)     It’s Just Too Inconvenient – Patients do not always share the same enthusiasm you do about your study. Some may have already resigned themselves to a new normal and are simply going through the motions because of family encouragement. It’s important to put yourself in their shoes and explore “patient intent.” Ask them (with a smile), are you committed to this trial? The answer may surprise you.
 

2)     Negative side effects: Clinical trials invariably involve the testing of a new therapeutic or diagnostic product on humans, which can lead to unexpected side effects and risks for patients. As such, participants may leave the trial early due to experiencing an adverse or unexpected reaction to the treatment.

3)    Lack of efficacy: Participants may decide to opt-out of a clinical trial if there appears to be no clear benefit to the treatment being studied, such as when there is no improvement in symptoms, or the treatment is not significantly helping the condition that the patient has. 
 

4)   Difficulty with compliance: Compliance with the clinical trial protocol, such as visiting the trial site regularly and adhering to required tests and treatments, can be challenging for some participants. Trial sponsors should minimize complexity and lessen the strain of paperwork on trial participants and their families. This can be done by implementing patient recruitment services such as Trial AMPlify which streamline the recruitment process and offer easy-to-use tools such as discussion forums and eligibility checker which allow potential participants to get real-time access to patient engagement functions. Participants may choose to end their trial participation if they find it difficult to meet the standards.

5)   Schedule conflicts: Work, family, and other commitments can interfere with participants’ ability to make scheduled visits or complete required check ins. Increased burden of participation: When faced with the added burden of participation in a clinical trial (lab tests, additional medications, extra doctor’s visits, etc.), patients may decide that they’re not up for the challenge and drop out prematurely. If possible, trial sponsors should take steps to make enrollment and follow-up appointments more accessible and affordable. This can include, but is not limited to, offering reimbursements for lost wages and transportation costs, providing price caps to participants for medication costs, and scheduling appointments to meet patient needs.
 

6)   I’m Good! I Feel Better - A rarer but known reason why some patients leave a study early is they actually feel better, and think they are "cured" or no longer need treatment. This can lead to withdrawal symptoms in some cases and make the patient feel worse in the coming weeks.
 

7)   Lack of proper education and engagement: Many times, clinical trials can be confusing and overwhelming for the patient. Trial participants should have a good understanding of the research and implication of the clinical trial. This can be accomplished by having a detailed explanation of the study provided to them prior to enrollment and ensuring that all pertinent questions are answered and understood. In addition, trial sponsors should partner with clinical trial sites to ensure that trial participants have a full understanding of the process and understand the expectations that come with participation. Without a comprehensive education and engagement program in place, patients might not understand the importance of the trial and why they should participate in the first place.

8)   Do You Have ANY Idea What I’m Going Through? – In some cases, patients are simply not feeling up to venturing out for another treatment that might not be making them feel any better (or which makes them feel worse.) Trial sponsors should create an environment of empathy and support to potential trial participants and ensure access to psychological and medical resources that may impede full participation. This can be done through the establishment of online patient support groups where those considering trial participation can interact with peers, create valuable connections and ask questions in a safe space.

9)   Lack of social support – One of the hidden factors for patient dropout is the lack of support for  family and friends. Handouts and supporting material in the beginning is a great way to get everyone onboard. Trial AMPlify encourages our clients to invest in Subject Enrollment Support Materials. These support materials can take the form of brochures or personalized mailers that are provided to enrolled subjects. Questions and concerns are raised and answered early in the study to help the subject deal with what might be a sometimes long and uncomfortable journey.

Summary:

By addressing these main issues, trial sponsors can improve the overall patient experience, reduce attrition rates, and prolong the duration of clinical trials. Trial sponsors have an ethical and moral obligation to ensure that clinical trials are adequately and ethically conducted, and working to reduce the abandonment rate of clinical trials is one way to do so. Although the steps needed to prevent premature abandonment require effort and dedication on the part of trial sponsors, they ultimately can lead to more successful and meaningful results in research.

Patient dropout is a reality for any clinical trial. The goal is to partner with a recruitment agency that can help you out of the gate to attract an abundance of the right kind subjects who will stick with your study.

About Trial AMPlify

Trial AMPlify is a full-service clinical trial patient recruitment and enrollment marketing agency that helps biopharmaceutical companies quickly identify and target patients for clinical research and world-wide studies. We recognize the crucial role diversity plays in patient recruitment, and we strive to ensure each trial has a broad, representative patient population that is reflective of the target treatment.

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