Don’t believe the hype. Most patient dropouts CANNOT be avoided.
In my 23 years of clinical research, I’ve seen that the large majority of patient dropouts are caused by two things: Lack of Efficacy (LoE) and Adverse Events (AEs). In other words, the patient is not getting better (or maybe getting worse) and/or the side effects are unbearable. Most industry figures report total drop out rates on average at 25-30%, and attribute two thirds of those to LoE or AE’s - i.e., approximately 20 patients for every 100 patients enrolled.
But what about the other 10 patients out of every 100? What is driving their discontinuation? The other common reasons as typically captured in a clinical database are listed below:
- Withdrawal by Subject
- Lost to Follow-up
- Non-compliance
- No longer met criteria
- Non-specified
Of course, these reasons are not always mutually exclusive of each other. A subject may “withdrawal” because it’s frustrating to remain compliant with study visits or at home tasks. Many that are “lost to follow up” may also struggle with compliance, but just aren’t comfortable enough communicating this to the site, so they ghost. “No longer met criteria” may be related to “non-compliance,” as well if there is an underlying patient behavior that drives eligibility. Finally, there is the mysterious, “non-specified” reason, which honestly, I have never really understood what this means. Typically, researchers are instructed to assign one primary reason for a dropout in this simplified manner, and so you never know what is else is really driving dropouts, outside of LoE or AE’s.
Fortunately, every 2 years, CISCRP conducts a global study on public and patient views of clinical research. The 2021 report lists the following as the Top Retention Factors for patients, with the number one factor being, “Study Drug Benefit.” After that, the list falls within the following broad categories as I have defined: Compensation, Transparency, and Convenience.
In other surveys, non-medical reasons for stopping participation include the location of the study center (13%), poor communication with the study center (11%), and an overly burdensome time commitment (11%). But what if you could keep those last 10 participants from dropping out? Or better yet, maybe you can even inspire a participant to stick with the trial despite LoE or AE’s, because you've vastly improved on areas of Compensation, Transparency, and Convenience?
On every protocol we’ve assessed and digitalized at ProofPilot, we always discover lots of opportunities to improve on these areas through automation of tasks, content, communication, technology, and payments. One of the most eye-opening discoveries for our customers is exactly how difficult and isolating their studies are for patients. On a recent project, we calculated over 400 days where a patient had no contact with the study team - out of sight, out of mind. How then do you keep the patient engaged and compliant without burdening the site staff? On another project, we calculated over 200 tasks required for the patient in order to be compliant. Relying on verbal instructions or paper handouts was just simply not going to do the job.
While it is true that a significant portion of patient dropouts in clinical trials is due to Lack of Efficacy and Adverse Events, there remains an opportunity to mitigate other factors contributing to discontinuation. By identifying and improving areas such as Compensation, Transparency, and Convenience, we can positively impact retention rates in clinical studies. Utilizing platforms like ProofPilot can help streamline these improvements by digitalizing the protocol workflow and automating core tech tasks, enhancing the overall trial experience for both patients and site staff. These adjustments not only ease the burden on patients and study staff but also ensure better engagement and compliance. So, while it may not be possible to eliminate all dropouts, we can certainly strive to create a more patient-centric approach in clinical research that minimizes the non-medical reasons for discontinuation. The result? A more efficient and inclusive clinical trial landscape that benefits both the research community and the patients who stand to gain from its outcomes. Curious about how your protocol might really look once it's been digitalized? Give us call, we can help.
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