Decentralized clinical trials involve a combination of participant-centered design with innovative technologies. Decentralized clinical trials can either be fully remote or adopt a hybrid approach where some physical-site attendance is required. They are achieved with the use of remote monitoring and diagnostics, home health providers, local labs, digital capture of consent data, and direct-to-patient drug distribution. The purpose of these types of studies is to reduce or completely eliminate the requirement of face-to-face interactions between researchers and participants.
Decentralized clinical trials can help make research studies more accessible to a wider demographic of participants who would otherwise not take part in site-based research. Furthermore, other benefits include improvements in recruitment and retention of participants, greater engagement and diversity, and a reduction in the costs required to run trials. However, several systematic reviews of decentralized clinical trials have also highlighted their disadvantages compared to conventional clinical studies.
Since the introduction of clinical postal-based clinical trials in the 1980s, the tools, and approaches required to utilize decentralized clinical trial designs have changed drastically. Moreover, the significant developments in technology over the years in conjunction with the pandemic provide researchers with ample opportunities to adopt such a clinical design.
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The Advantages of Decentralized Clinical Trials
The major advantage of decentralized clinical trials researchers have identified is the ease of participation as it allows for flexibility, requires fewer in-person study visits, allows for passive data collection, and removes barriers to participation such as geographical factors, time, and travel.
Furthermore, there are several added values of decentralized clinical trials in terms of the research that is conducted. Firstly, there is better generalisability of trial results as decentralized studies allow for diverse and representative cohorts, thus improving research quality. Secondly, there is better patient engagement as it enables participants to self-manage.
In addition, decentralized clinical trials provide the possibility of improving overall healthcare. This is because they permit the conduction of trials in rare diseases with geographically dispersed patients, thus driving an improvement in the scientific understanding of such diseases. Moreover, they help generate useful individual patient data, provide quick answers to clinical questions or concerns, promote remote healthcare delivery, allow for continuous monitoring of adverse effects, and finally provide a better understanding of the patient experience.
The Disadvantages of Decentralized Clinical Trials
A significant disadvantage to the utilization of decentralized clinical trials is patient safety. There is a risk of physical harm being imposed on participants if they inappropriately or unsafely administer the trial medication. Furthermore, the complexities of these remote clinical trials may lead to patients poorly comprehending the study purpose, leading to reduced adherence especially as there are no face-to-face interactions to check understanding. This can ultimately lead to inaccurate research findings which will negatively affect healthcare interventions.
Also, this method can create a huge burden on patients as they have to activate, charge, and wear digital sensors for several hours, which may even jeopardize the success of these virtual trials. In addition, the lack of in-person support and emotional burden may negatively impact participants. This method can also create a huge burden on trial staff members due to the challenges in providing technical support to participants, as well as having to learn to manage advanced and new technologies required to run decentralized clinical trials.
An Example of a Decentralized Clinical Trial
Home blood pressure monitors (HBPMs) offer an out-of-clinic blood pressure measurement for patients with hypertension. HBPMs allow patients with hypertension to increase both awareness and self-management required to adequately control their condition, thus reducing the risk of cardiovascular disease and all-cause mortality. The TIME study was a remote decentralized clinical trial designed to assess the validation status of various HBPM models.
The Time study utilized an information technology-based methodology to monitor patient outcomes remotely. This was achieved through a TIME study web interface which allowed patients to report their blood pressure measurements obtained from their HBPM regularly. A large sample size of participants was obtained due to the flexibility the decentralized trial provided.
The overall consensus of this study was that the majority of participants (81.3%) owned an HBPM model that had evidence of validation by the dabl Educational Trust or the British and Irish Hypertension Society (BIHS). Whilst the rest of the participants (18.7%) owned HBPMs lacking clear evidence of validation. Thus, highlighting the need for improved education on choosing validated HBPMs by healthcare professionals for the safety of their patients with hypertension.
Conclusion
Decentralized clinical trials are a developing field within research. This approach can be applied to several therapy areas and research questions. Decentralized clinical trials possess significant potential due to their ability to harness technological developments to improve the efficiency, participant experience, and generalisability of clinical studies. Despite their advantages, there are many downsides to decentralized clinical trials in terms of patient safety and staff and patient burden.
It is imperative for researchers conducting decentralized clinical trials to publish their findings, highlighting both the positive and negative impacts on patients, staff, and research data obtained. Such knowledge will help to make informed decisions about the applications of decentralized clinical trials in the future.
Continue Reading: Insight into the Different Clinical Trial Study Designs
References:
- Anbarasan, T., et al. (2022). Home blood pressure monitors owned by participants in a large decentralised clinical trial in hypertension: the Treatment In Morning versus Evening (TIME) study. Journal of Human Hypertension. 36: 32-39.
- Coyle, J., et al. (2021). Learning from remote decentralised clinical trial experience: A qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders. 1-12.
- Rogers, A., et al. (2022). A systematic review of methods used to conduct decentralised clinical trials. Br J Clin Pharma. 1-20.
Further Reading