Centering Clinical Trial Schedules Around Patients – Tools To Increase Enrolment & Retention

It has never been more important for sponsors and sites to really consider what committing to a clinical trial actually means for not just for the patient, but also their loved ones and carers. Joining a trial is an additional commitment and can become a disrupter in their daily lives if the trial is not designed or managed with them in mind.

This seems to be the case for many - with an average of 25.5% of patients dropping out of trials after giving consent. The reasons for deciding to leave ranged from fear of the treatment they would undergo, to lack of support for themselves and their family from the study team. [1]

So how do we limit these disruptions – whether it be rooted in time commitments, anxiety, a lack of additional support, etc. – and not only limit attrition but actually increase enrolment?

Changing Perceptions

There needs to be a switch in how patients are viewed. They are not just a pool of people, in grouped locations, that we as researchers can potentially tap into – rather, the trial needs to become a resource that the patients are tapping into.

This can be done by designing a trial that does not demand long commutes as well as providing patients with the time and reassurances they need from study teams to keep them engaged and comfortable with continued participation. Yet, if it were that simple, it would be the norm. Study teams are already stretched with limited resources, and study locations are, more often than not, centralised in major cities and academic hubs. So how is it possible to make trial participation feel like less of a burden and more of an opportunity or resource for patients?

Switching Tactics

The key to making a trial a resource for patients lies in making it more accessible to them – both physically and, in many ways, emotionally. Patients and their families need to feel supported and that is harder when they are exhausted from traveling to and from the site, and if the study teams are stretched and unable to give the time needed. Switching tactics when it comes to trial design can help with this. While there is no one-size-fits-all solution, there are multiple possibilities that can be used individually or in tandem with more traditional models.

Flexible, Accessible Study Sites

Utilising commercial study sites can both enhance physical access to the site but also provide patients’ more time with study staff. These sites are usually located outside of major urban centers and have appointments available outside of traditional office hours – making it easier for patients to plan their visits around their schedule and not around the limited availability that traditional sites have. Further, these study teams are only conducting research and therefore have more time to spend with patients as they are not required to perform additional duties as their public health and academic counterparts are.

In addition to brick & mortar site locations, it is also possible to create ‘pop-up’ or satellite clinics that can be set right in the heart of communities – in places such as schools / town halls, local GP practices, village community centres etc. Anywhere there are patients, these clinics can effectively be set up, providing the same flexibility and resources as their more permanent counterparts.

In-home Healthcare

While pop-up clinics bring trials into the community, in-home healthcare (also known as in-home nursing) or Home Trial Support (HTS) brings the trial right into the patient’s home or other preferred, suitable location.

In-home clinical trials, or HTS, can be used to alleviate the amount of travel the patient may have to do and gives them access to a dedicated healthcare professional (HCP) who can focus solely on them. This can also greatly benefit the study site, as a pre-determined number of visits are carried out in the patients’ home – alleviating the number of visits that would need to be performed at the site. Further, the in-home HCP can observe the patient in their daily environment and provide feedback to the core study team that may give them greater insight into what environmental factors may be impacting the patient, giving them a chance to address those and provide additional support if needed.

Telehealth is another way to alleviate travel burden and potentially give patients more time with HCPs. By connecting via phone or video call, it can be a highly effective way of connecting with patients – giving them flexibility and minimizing travel and logistical burdens.

Conclusion

The location of clinical trial visits plays a key role in patients’ willingness to both participate and remain in the trial. When long distances, or traffic-heavy locations, are involved, combined with limited appointment flexibility and time strapped clinical staff, it becomes a drain for many, very quickly. This is not factoring in many of the other logistical and physical challenges the patient and their loved ones may be facing.

Yet when a trial is designed with solutions in place to address these and many other burdens, patients can look to them as a resource that has the potential to improve their quality of life, in both the short and long term. When immediate value can be felt, there is a much higher chance of enrolment and continued engagement.

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References:

1. Poongothai S, et al. Strategies for participant retention in long term clinical trials: A participant -centric approaches. Perspect Clin Res. 2023 Jan-Mar;14(1):3-9. doi: 10.4103/picr.picr_161_21. 123