There are many reasons why patients drop out, and while some are due to uncontrollable circumstances, the majority of them are preventable with a robust patient recruitment strategy in place.
Here are some key research findings and insights on the subject that may help point CRAs, clinical recruiters or marketers in the right direction when it comes to improving patient recruitment strategies for clinical trials.
Why do clinical trial patients drop out?
Published research by the National Research Council on The Prevention and Treatment of Missing Data in Clinical revealed that the most common reasons for dropouts were negative reactions to the treatment (believing it to be ineffective, or finding the side effects unacceptable), and issues with location.
They also found that further patients discontinued for a variety of reasons including the inability to tolerate the intervention, lack of efficacy for the intervention, and difficulty or inability to attend clinical appointments and complete medical evaluations. Lastly, there were patients in the study that withdrew their consent or experienced life changes that would complicate further participation in the clinical trial.
Increasing patient support and instilling trust
In his book The Uphill Path to Successful Clinical Trials, medical writer Walter Alexander discovered from various credible sources that 40% of Americans would not participate in a clinical trial and more discernibly, 25% of those surveyed answered yes to the question “would your doctor expose you to unnecessary risks in a clinical trial?”
A CISCRP survey also found that a large portion of participants no longer considered participating in a clinical trial to be a noble endeavour. Instead Alexander found that many participated because they were either very sick without any other option, or looking to make money.
That is quite a mountain of distrust to climb, but if you are struggling with high patient dropouts, it is worth asking yourself the simple question: do patients trust us? And furthermore, what can we do to instill more trust during the pre-screening process? For example, you could create a professional and easy to use online resource that enables participants to gain a deeper understanding of the clinical trial process or set up regular face to face drop in sessions that enable active or potential patients to ask any questions throughout the process
How can I improve patient retention during a clinical trial?
According to patient recruitment and retention firm MediciGlobal, patients who directly approached CROs for participation online had a 38% lower risk of dropping out, based on analysis of four trials, compared to those trial participants who were found and recruited. CEO of King of Prussia at MediciGlobal Liz Moench also explained that a rigorous pre-screening at the beginning of a clinical trial can “lead to higher retention rates downstream”.
Looking to another expert in the field, in an interview Scott Connor, VP of Marketing at patient recruitment company Acurian, explained that the key to improving dropout rates is in adjusting techniques to fit the particulars of the clinical trial and protocol. For example, your patient recruitment strategy could simply include increasing communication with participants when there are large gaps between visits. In the interview he said:
“The formula for effective third-party retention services is direct and simple. In a manner that is customized and individualized for the study protocol, the site, and the patient, organize schedules and tasks with sophisticated software, track progress to identify retention issues before they become intractable, take on administrative tasks in a manner that encourages stronger bonds between site staff and patients, and reduce the site staff’s overall workload.”
There you have it. To improve patient retention during a clinical trial, you need to be as flexible as possible, maintain open communication in a way that suits participants, customise the programme to the individuals involved, and track progress with the latest tech.
Enhancing your patient recruitment strategy
There are plenty of resources out there, but the resounding message is that CROs need to refine their patient recruitment strategy to be more flexible and connected with participants from start to finish. While putting this into practice may take time, the benefits of avoiding costly delays and missing data from high patient dropouts will be very much worth the forethought.
One way to reduce drop out rates is to attend patient recruitment and retention 'booster' meetings, which are one-day local focus events to take place half a year after you have attended the initial investigator meeting. These are opportunities for investigators to share challenges, solutions, successes and best practice, working together to retain patients for clinical trials.
Our significant experience in clinical events shows that studies in which investigators are engaged and supporting one another are more successful, and patient recruitment and retention rates are ultimately much higher.