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  • Writer's pictureYVAN LAMOUREUX

Do We Have the Right Understanding of How Patients Perceive Digital Clinical Trials?

The concept of decentralized clinical trials refers to trials carried out through telemedicine and mobile technologies and mobile/local healthcare providers without the limitation of geographic location.


The standard clinical trial process can be inefficient and costly. These trials place a significant burden on participants regarding travel and other logistics. By using new technologies and methods to promote a decentralized model, clinical trial efficiency could be increased.


Despite the COVID-19 pandemic setting back clinical trials, it also brought about a revolution in how they are conducted. Potential patients were either unable or reluctant to visit physical research sites during the pandemic. In contrast, some sites suspended ongoing trials to redirect the necessary resources to critical care. Furthermore, the pandemic increased socioeconomic disparities and made it more difficult to reach diverse patient populations, necessitating restructuring and redesigning clinical trial coordination methods.


Decentralized or remote clinical trials have gradually gained traction in the last half-decade. Even though COVID-19 has accelerated digital healthcare tools and telemedicine adoption, decentralizing clinical trials is still a relatively new concept. Part of the problem is a lack of clarity regarding what a DCT is and what it entails, as well as regulatory uncertainty.


From November 2020 to January 2021, Kayentis conducted a study on patients’ readiness to participate in remote clinical trials. The study included 1,133 individuals with various health conditions from across Europe and North America. This article presents Trishna Bharadia’s views on the study’s outcomes from her role as a patient engagement advisor and health advocate.


Clinical Trials Participation

Enrollment and patient retention are common problems in clinical trials. In addition to enrollment difficulties, some studies estimate that up to 30% of patients who join a clinical trial drop out. Maintaining the patients’ perspective throughout a clinical trial can help at every stage. But what are some common hurdles when it comes to joining a clinical trial?

  • Lack of awareness — Clinical trial awareness, in general, is a significant problem. As many as 70% of the survey respondents were unaware that clinical trials were taking place. The more people know about clinical trials, the greater the chance that they will participate.

  • Fear of the unknown — People are usually hesitant to get involved because they fear what they do not know. As many as 55% of survey participants stated they refrained from joining for health-related reasons. Potential side effects, the possibility of receiving placebo and unknown outcomes are common fears. Although researchers cannot guarantee outcomes, patient safety is always of paramount importance.

  • Inconvenience — Some people cannot dedicate the time required to participate in research studies or find they cannot work around their schedules. Others see a lack of transportation or access to a study location as the most significant hindrance. Some groups may be underrepresented for a variety of social and economic reasons.

So, what is the best way to encourage clinical trial participation? A key to effective clinical trials and recruitment is to ensure that they are targeted, relevant, and conducted appropriately. For trials to be relevant, stakeholders will have to work together more effectively.


Furthermore, the issue of awareness should be addressed. Developing better relationships with patient organizations, patient advocates, sites, healthcare professionals, and some community organizations is vital because the public needs to be educated on the importance of clinical trials and how to obtain more information.


It is a fact that clinical trial participants tend to know more about clinical trials and are more likely to be informed enough to understand their value than the general population. This experience and awareness are directly related to patient engagement.


The survey found that patients who belong to the 30 – 50 age group are the ones who refrain the most from participating. This might be because this generation has children or elderly parents to look after or other personal and financial commitments. The best way to approach them is by being transparent and providing them with clear information, especially those concerning informed consent and patient participation sheets. Being aware of what they are getting into and the possible risks and benefits can maybe alleviate some of the fear of the unknown.


Patients’ Experiences With Digital Solutions and DCT

Patients who have never worked with specific software or incorporated any technology into their previous clinical trials may be hesitant to use unfamiliar technology. Moreover, because patients value their relationships with clinical investigator staff and researchers, it might be challenging to develop these relationships if they don’t see one another very often. The good news is that hybrid trials can address these concerns by focusing on patient education and flexibility.


Over the past few years, decentralized trials have become more popular with patients and proved effective. The use of telemedicine and digital healthcare technologies has increased significantly during COVID-19. As many as 85% of the patients commented that they are ready for decentralized or hybrid clinical trials.


Technology Needs to Be Accessible and Patient-centric

Listening to the participants is the key to creating a patient-centric trial design. Research sites could provide in-person training and support to patients via video and chat. They need to consider what mix of technology and in-person visits will work for the patients they are trying to recruit when designing decentralized trials.


Interestingly, 47% of patients stated that they would prefer a home-based clinical study, while 42% would opt for a partially remote trial for their subsequent clinical trial.


Previous Clinical Participation Influence

Many of us believe that digital solutions remain underused, and at the same time, most patients are hesitant to adopt technologies. In reality, though, that might not be the case at all. The study shows that 71% of patients have already used an electronic device in their previous clinical studies, whereas 85% rated their experience with electronic devices as highly positive. Thus, it is evident that the industry has a solid base for potential success there.


Digital tools were important only to 13% of those who had never taken part in a clinical trial and 27% of those who had. It follows that education and proper training are needed to ensure people are aware of their importance.


Final Thoughts

Study results show that many patients choose decentralized or hybrid clinical trials over fully centralized ones if given a choice and when informed. Furthermore, what people want is the ability to conduct remote visits, to have a user-friendly device allowing them to be reminded of obligations, and to be able to chat with site staff or support staff.


Therefore, researchers must listen to patients’ concerns about using technology, interacting with researchers, and protecting their safety to expand hybrid trials. Moreover, they have to employ a proper promotion strategy.


In addition, clinical trial teams should craft patient-centric trials that give participants plenty of opportunities for support and training, ask questions, and learn about safety regulations. Support from physicians, nurses, and clinical research coordinators, transparency of expectations, and good patient involvement are some solutions that will increase patient participation.


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