With the emergence of COVID-19, decentralization of clinical trials has become the primary topic of discussion over these past years, further enabled by advances in the available technologies. The medical industry has realized that the way clinical trials are done should be shifted from traditional trials to decentralized clinical trials.
Hence, the adoption of Decentralized Clinical Trials (DCTs) is not an option anymore. It has become a necessity to comply with social distancing requirements while carrying out important research. So, here, in this blog, we will illuminate some of the benefits of decentralized clinical trials to give you a clear idea of this topic.
An Introduction to Decentralized Clinical Trials
Different terms can be used to define decentralized clinical trials such as remote, virtual, siteless, etc. Regardless of the term you may use, the main aim here is to simplify clinical trials for patients by eliminating the need to drive to a specific location. It is seen that this approach is beneficial for increasing the study effectiveness, decreasing the drop-out rates, and also marketing life-changing drugs faster.
Decentralization does not imply conducting clinical trials when healthcare professionals are absent. It also does not completely eliminate the need for physical patient contact. Rather, it can help in making research studies way more accessible to a wider range of populations who would not otherwise participate in site-based studies.
‘Patient-centricity’ is mainly a popular term that is widely discussed for several years now. we all understand that if the required cost and time of the clinical trials will reduce, then it would help the participant to take off the burden from their shoulder and deliver more efficiency and high retention rates. Hence, you can say that decentralized clinical trial is mainly considered to be the patient-centric approach to the design of clinical trials.
Undeniable Perks of the Decentralized Clinical Trials
You have to keep in mind that decentralized trials do exist in a broader spectrum. Unlike traditional clinical trials, decentralized clinical trials have appeared to be a more patient-centric approach by reducing the physical barrier to participation by implementing several new and advanced technologies.
It is widely popular because of the convenience and flexibility it provides. It also cuts down a lot of time by eliminating the travel burden to the clinical site and the interruption of the daily activities of the participants.
Since the introduction of decentralized clinical trials, we have seen a significant development in technology that has changed the design of clinical trials completely. Hence, it opens a way to adopt DCT to avail several benefits starting from enhanced data security and reduced cost to real-time data monitoring and reduced time. However, here, we will discuss the benefits of decentralized clinical trials in detail below.
In traditional clinical trials, members of the clinical operation team need to do trial data monitoring of local people. Hence, all the participants have to travel to a specific location to finish their visits throughout the study which can interrupt heavily in their daily-life activities.
But, on the contrary, the decentralized clinical trial generally offers a patient-centric approach using virtual tools like wearable technical devices and telemedicine to conduct remote visits and monitor all the data. So, the major benefit of DCT is that it offers the utmost flexibility when it comes to submitting data while sitting at your home.
Enhanced Data Diversity
In traditional clinical trials, the participants need to visit every other location and have to be present there physically. But now the technology has changed and it has come up with decentralized clinical trials which effectively minimize the geographic barriers to research for participants from different populations.
It includes those who are from remote areas, elder people, ethnic minorities, etc. However, with this clinical trial approach, participants are able to collect a lot more diverse set of data that will help in increasing clinical trials’ external validity.
Having access to a huge population through a much larger geographical footprint, and decentralized clinical trials allow for the bigger picture to capture and how this new approach may affect the different patient groups.
By implementing mobile technology, decentralized clinical trials give the participants the opportunity to collect more data as compared to conventional site-based clinical research. So, one of the major benefits of DCT is that it helps the participants to collect larger data with accuracy.
Improved Patient Recruitment and Retention
Decentralized clinical trials have the capability to better patient recruitment and retention. In successful retentions, it uses methods that will help in keeping the patients engaged positively and encourage them to stay until the trial is completed. Here, an individual must understand and emphasize the experience of the patient.
When the participant comprehends the significant burden of the patients, then there is a higher possibility of attrition. Things such as frequently scheduled online visits maximize the dropout rates.
DCT has the potential to alleviate such burdens by concentrating on trial participants using telehealth services for wearable devices and remote visits to collect virtual clinical data. However, the trial designs have to use these digital technologies when managing strict patient safety standards.
Virtual Communication with the Patients
Effective communication between the study site staff and the patient plays a very important role when it comes to keeping the patients encouraged and improving retention. One of the main benefits of decentralized clinical trials is that it offers an advanced tool named electronic patient reporting outcome (ePRO) to continue the communication virtually.
Through this, patients can immediately report any symptoms whenever they occur, maintaining safety issues. In addition, the telemedicine feature helps the patients to communicate with the staff in real time at their convenience. They can use eReminders to submit valuable data in real-time continuously.
Decentralized clinical trials are mainly a developing area of research. This approach can be used in different therapy fields and research questions. Decentralized clinical trials have the capability to exploit technological developments to improve patient experience, performance efficiency, and the generalizability of clinical research. The decentralized clinical trials also possess some challenges as well, but despite the downsides, it has lots of benefits to offer.