Conventional clinical trial models revolve around a study site with participants being required to travel to the clinic to give data. Decentralized clinical trials (DCTs) are a modern research paradigm that employs digital technology to improve all stages of a trial, from recruiting and enrollment to engagement, retention, and data collecting, with capabilities achievable outside of a clinic.
According to a recent report, the global Decentralized Clinical Trials market size was valued at USD 4476.49 million in 2022 and is expected to expand at a CAGR of 15.42% during the forecast period, reaching USD 10582.65 million by 2028. While these numbers are promising, they still cannot be compared to a traditional clinical trial.
A decentralized clinical trial has several advantages, including a better participant experience, but clinical trial sponsors and researchers have been sluggish in adopting it. Here, we address five of the most pertinent myths about DCTs that have contributed to their relatively low acceptance.
Myth 1: All components of the study are decentralized:
The phrase "decentralized clinical trial" might mean that the entire research protocol is digitized and relocated away from the clinic. DCTs, on the other hand, are simply described as studies including digital data gathering outside of a study location, as opposed to studies that collect all data online. Several trials that now use DCT technology use a hybrid trial approach, which gives participants additional options, potentially increasing interest and compliance.
Decentralized clinical trials software and digitization enable different components of a protocol to be improved to best meet the research purposes and boost possible pools for recruitment while sustaining engagement. This gives researchers additional possibilities for meeting participants in ways that are both effective for the study and efficient for the participant. This allows the study team to explore solutions that would not have been viable owing to geographic or physical constraints.
With the optionality allowed by DCT technology and digitalization, in-person data collection may be supplemented with research activities that the participants can perform in the way that they desire. Surveys or participant-reported outcomes, for example, might be completed remotely, at the participant's convenience, or during an in-person visit in the presence of a research coordinator.
Similarly, blood or saliva samples may be obtained at the clinic, at a Quest site, or at home using an at-home kit. These alternatives allow individuals from a far broader range of conditions and restrictions to engage. Finally, DCT technology allows for more engagement and more reliable data collecting while keeping the participant experience in mind.
Myth 2: Virtual recruitment is ineffective:
A prevalent misperception regarding DCTs is that recruiting patients is too difficult without an established in-person connection. Alternatively, by reducing geographic obstacles to participation, recruitment may be improved by allowing a greater population to interact for possible enrolment. This recruiting is further aided by the addition of new recruitment channels such as social media, QR codes, websites, emails, and others.
Participants may find clinical trials on their own by permitting in-person and remote interaction, rather than depending entirely on doctors to recommend patients to appropriate forthcoming studies. This improves studies by broadening the scope of outreach, allowing for a more diversified participant base. Finally, DCT technology can reach more people and produce more detailed research results by utilizing the finest in-person and remote ways to locate and engage with participants.
Myth 3: DCTs worsen the digital divide:
When contemplating implementing DCT technology in a clinical research context, one prevalent issue is the introduction of biases caused by necessitating the use of a mobile phone or other internet-connected devices. Recent studies, however, show that the digital divide in the United States has narrowed, and underrepresented populations—sexual and gender minorities (SGM), ethnic/racial minorities, females, and other underrepresented or underserved populations—make good candidates for participation in digital clinical studies.
For example, 85% of persons with SGM use social media in some capacity, and 91% of those with a physical or mental handicap own a smartphone or tablet.
For people who do not have access to technology or have minimal digital literacy, data gathering can still be done in person. DCT technology broadens the methods for any participant to contribute data and properly participate in a study.
Myth 4: Electronic consent models impede study understanding:
Using typical long-form permission agreements, participants are often able to grasp common components of clinical trials (e.g., voluntary participation, the ability to withdraw at any time, etc. ). Many participants, however, continue to struggle with the concepts of a placebo, randomization, dangers, and potential adverse effects. This misunderstanding can have an influence on recruitment, study adherence, and retention rates.
A prevalent myth about DCTs is that digital, eConsent models, in which a research coordinator does not take the participant through the permission process in person, will further reduce participants' knowledge of the study. In reality, DCT technology can potentially boost study understanding by improving consent forms.
Clinical trial consent can be improved with technology by using multimedia material and delivering information in the participant's chosen language. It has been demonstrated that multimedia material improves participant comprehension of trial details. Because participant learning methods differ, this multimedia content can be used to complement long-form consents.
Technology also makes it possible to offer consent information in a language that the person understands. Moreover, tailored quizzes that validate understanding and offer further resources to address identified gaps can be used to test and enhance comprehension. Finally, if certain populations or groups of participants require one-on-one discussions with a research coordinator, it may be better tailored to the individual's requirements.
Myth 5: DCTs impose additional burdens on research locations and participants:
DCT technology introduces change to study locations, which naturally raises concerns about increased responsibilities and complexity. A well-implemented DCT focuses on removing the difficulties associated with necessary on-premise activities for both participants and coordinators while enhancing the manageability of these tasks in a virtual context.
DCT technology transfers work from the clinic to a suitable time in the participant's day for research locations, making interactions more comfortable for the participant. Not only is this more convenient, but information is frequently asked closer to an important event, reducing the strain associated with recollection. Participants often prefer this style of contact as long as the additional convenience is not outweighed by the demand for more data.
DCTs generally demand less time from research coordinators, in addition to enhanced participant convenience, because a lot of tests no longer require direct interaction.
The time saved in scheduling assessments and reminding participants of impending assignments and visits to ensure compliance can be spent to focus on high-impact engagement for selected participants with special needs. With automated notifications and reminders, as well as participant dashboards and reward systems, research teams may achieve improved compliance and adherence rates with less time and effort during clinical investigations.
In Summation
Now that we've broached the five most common myths about DCTs, it's time to embrace the fact that decentralized and hybrid trials are here to stay. Apart from the patient's convenience and the increased level of continuous monitoring, DCTs aid the investigators and overall clinic operations. Doctors have more "chair time" to meet with patients (virtually or in-person), waiting times are lowered for everyone - not just the study participants, but all patients - and physicians can be more productive with their time. But how does one go about conducting a DCT, especially APAC decentralized clinical trials?
Octalsoft, a long-standing leader in the DCT field, is here to assist. We provide specialized, qualified advice and a comprehensive eClinical suite for end-to-end DCT trial design and implementation. Our industry specialists can lead a complete, multifaceted strategy to ensure organizational success and end-user uptake while our eClinical suite sports all the tools and software systems that a modern clinical trial requires.
To learn more about how Octalsoft can assist you in developing and implementing a decentralized clinical trial system that links trial experiences for patients, sites, and sponsors,
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