The success of clinical trials depends on multiple factors. Only a handful of those factors however, are irreplaceable. Factors being irreplaceable means that no amount of alternative resources can make the trial successful. Patient engagement is one such irreplaceable factor. Engaging patients is necessary throughout the entire clinical trial. It begins with recruitment and ends with the study’s conclusion. That’s why recruitment is often grouped with retention in industry literature.
In the past, while some trials faced issues engaging their patients that could have been addressed, many trials faced unavoidable challenges with engaging patients from various demographics. Because, while patient engagement in some clinical trials was sufficient in some instances that predate much of the technological advances we have today, the level of technology available at the time was a major obstacle towards advancing patient engagement in clinical trials as much as it should have been advanced.
Things are different today, though. With a number of commercially available technological strategies and enhancements for patient engagement, the potential to increase success rates of clinical trials with parameters that would have previously been detrimental to patient engagement has never been higher. Let’s look at some of these options and strategies.
1 – Electronic Consent
Not to leave the obvious unstated, eConsent solutions are one of the first things that spring to mind when thinking about the use of technology to enhance patient engagement. eConsent solutions are ideal when they give patients the space to express informed consent using interactive ways that they feel most comfortable with. Interactivity is a great approach towards engagement. For example, some electronic consent solutions offer patients small quizzes to ensure that they understand the part of the trial process they’re currently engaging in, as opposed to just getting them to store an electronic signature.
At this point it’s very important to note that while the right eConsent solutions help keep patients engaged and better informed, these solutions are meant to enhance the informed consent process for patients throughout the trial, rather than replace existing structures. For example, observations by site or clinical team members as to a patient’s state of mind, demeanor, and even body language on video calls, or in-person for site visits in hybrid and conventional clinical studies, are still vital to the consent process.
2 – Patient Access
For a patient, being in a clinical trial may be a lot to keep track of. The general trial information, the general trial protocols, the steps to take in certain contingencies, the documents which register consent at various parts of the consent process, the notifications sent by researchers and clinical sites, and so much more. A dedicated log-in space where everything can be at the patient’s fingertips goes a very long way towards increasing patient engagement.
This kind of access, a researcher-access portal solution for all information relevant to a trial, seems like a given. But in fact, the less obvious aspect of that is that all clinical study stakeholders would benefit from a digital, highly organized point of access for all of their relevant trial information. A place where information is not just stored for everybody to access easily, but where communication between the relevant parties can be consolidated as well.
Since patients are stakeholders, this includes them as well. For patients this specifically means that they would need a dedicated Patient Access Portal to log in, keep track of all the relevant medical information, all the forms they signed, questions they answered, and even quizzes they answered.
If this patient access portal is also equipped with advanced instant messaging or chatting functions, as well as compatibility with other communication methods, such as email, it would help patients to consolidate all of their communications with the study sites or other members of the research team, such as principal investigators and study coordinators. Making communication with other stakeholders more accessible is another in which this technology boosts engaging patients in a given study.
3 – Data Collection
There is a predominant perspective towards engaging patients by implementing data collection strategies and solutions. This perspective relates to ease of use. From that point of view, using solutions that automate data gathering from patients without involving the patients too much (e.g., not making patients log results from their wearables into their patient portals manually) actually increases patient retention because it keeps involuntary interaction with their solutions to a minimum. It also doesn’t inconvenience them at times which may be unsuitable, and, for technologically challenged patients, it doesn’t take much of their time. While this automated collection of data doesn’t directly increase patient engagement, the increased patient retention leaves more room for engaging those retained patients, in terms of retaining patients who would otherwise not be available to engage.
An arguable second perspective that may occur to someone, alternate to the predominant opinion, is that deeply involving the patients with their own data collection in terms of taking readings and logging them increases their understanding of the study, and thus, increases their level of engagement. This is because additional training and orientation are required for the patients to learn to be involved with the management of their own data, which means that their interactions with other stakeholders increase. This also increases their exposure times to the experts and gives them an opportunity to ask more questions that might not occur to them during other times. However, when considering this perspective in passing, one needs to remember that patient retention is an important prerequisite to patient engagement. You can’t engage a patient if they decide to leave because things are too complicated or inconvenient.
Ultimately, this may depend on the demographics of patients involved in a study or even their individuality. The ideal approach to data collection arrangements in this case, is to choose a highly customizable solution that may be compatible with a number of plug-ins, adjustments, and options. This way, you can customize some things study-by-study, or even patient-by-patient if you pick the right fit, as opposed to having to live with one level of data-collection automation (or lack thereof) for the duration of your team’s use of the solution.
4 – Scheduling
Following on the logic of automating data management, automated scheduling of virtual or in-person appointments for check-ins, orientation sessions, or data gathering, might also be beneficial to some patients’ engagement levels. Patients who don’t have to worry too much about when to do what once they give the other stakeholders their time preferences are patients who may have an easier time staying engaged throughout the study.
On the other hand, there may be patients which would prefer the opposite. Much like data management, the solution to this is to choose a highly customizable solution that allows for both automated and manual scheduling. The main thing is, you absolutely should ensure that your patient solution includes scheduling in the first place. Then you can look into the scheduling functions’ applicability.
Scheduling technology isn’t new of course. From individual scheduling solutions to multi-party calendars, scheduling has been integrated into many commercial business suites, so integrating them into Clinical Trial Management Systems and other clinical trial software solutions is not too difficult, and you’ll probably be able to find multiple vendors other there who offer some kind of built-in scheduling options.
However, ‘not all solutions are developed equal’. A calendar with the right interface for your patients as well as the customization options you want requires a little more searching than just making sure your chosen solution includes a scheduling option. After all, there’s a reason there are multiple software calendar options commercially available in other enterprises. There are even large software companies that specialize in electronic calendars. There are different needs out there. Clinical trial scheduling options are no different.
These are a few of the ways in which technology can enhance patient engagement in Clinical Trials. Ultimately, depending on the kind of trials you want to run, or help other people run, it may be advisable to consider a vendor who can customize a turnkey solution for you that includes all the above-mentioned enhancements (and all your other requirements) as functionalities which are seamlessly integrated into one singular solution for your use, as opposed to looking for the above-mentioned enhancements as individual, loosely integrated solutions. However you decide to approach things, enhancing patient engagement using technology is a terrific way to increase a clinical trial’s chances of success.