Co-authored by Reeshav Mittal(Clinical Trial Subject Matter Expert)
COVID-19 changed a lot of things. Forever. Arguably, in a good way. The changes I’m talking about are on the developmental front. Clinical, managerial, and industrial discovery. The concepts of remote work and telecommuting existed before the COVID-19 pandemic, but the stringent social distancing measures and physical isolation globally enforced for various periods throughout the past two years have driven the technological applications of remote work and telecommuting forward to unprecedented levels, and accelerated the already developing remote operational frameworks. So many things were discovered and developed to further aid remote work concepts. And while many people have returned or will be returning to their offices, a sizable number of people will continue working from home. That number will probably grow as more organizations choose to lease smaller spaces rather than large and costly real estate.
In the clinical research world, one of the most exciting new developments is the accelerated rise of Decentralized Clinical Trials. Conventional clinical trials are typically dominated by a location-focused model. A physically central location is integral to those trials. A place where the majority of trial participants and the majority of research staff must be present together for extended periods of time, in order to gather and interpret quality trial data as well as manage every direct aspect of the trial.
Decentralized Clinical Trials on the other hand are, like their name implies, not dependent upon a central location. Using various technological capabilities such as clinical trial management solutions (software) and wearable measurement devices (hardware), the participants in a fully decentralized clinical trial and its trial management staff can manage the collection, processing, and interpretation of data from multiple locations, remotely.
The acceleration in the rise of these Decentralized Clinical Trials inevitably compels comparison between them and conventional clinical trials. Let’s look at some of the key differences between these two trial approaches, shall we?
1. Decentralized Clinical Trial Characteristics
From a patient’s perspective, fully Decentralized Clinical Trials are very patient-focused in nature. Since they are not location-centric, their remote operations allow for the recruitment of patients living a considerable distance from the nearest member of the trial management team.
From a sponsor perspective, remote clinical studies offer a number of advantages, including a significant financial one. Scaling for conventional counterparts, Decentralized Clinical Trials can reportedly save sponsors over 30% of their conventional counterparts’ cost. But there are other advantages as well, pertaining to quality of data.
For example, the remote nature of decentralized clinical research allows for study participants from rural areas to be better represented as a demographic in clinical trials. They are empowered to participate since participation doesn’t entail uprooting their lives to live at the trial site for extended periods of time. Other types of geographic diversity have also become facilitated. Participants from different cities, or even different countries, could take part in Decentralized Clinical Trials. In fact, even urban participants who would not otherwise take part in clinical studies become empowered to participate during Decentralized Clinical Trials.
Implementing clinical trial decentralization procedures is also beneficial for sponsors because of the way it affects their teams, since clinical research associates and other clinical staff are able to monitor trial data remotely. This allows sponsors to offer more flexible working conditions, which is an important factor in recruiting spectacular talents amongst clinical professionals. It also considerably reduces costs in terms of office space and staff commuting.
But DCTs also face their own share of challenges. DCT’s come with reduced in-person interaction between clinical research staff and trial participants, which may affect the rapport level between them. Rapport is important to avoid miscommunication which may affect the quality of data collected from a clinical trial. It is also a key component in ensuring the compliance of trial participants with the requirements of the study, and compliance with the requirements of the study is, in turn, a factor of consideration for data quality.
Another challenge worthy of note is that although DCT’s tend to improve the demographic diversity of trials and studies, they can also negatively affect demographic diversity, since they usually naturally preclude technologically challenged potential participants from taking part in the trials. This eliminates quite a number of potential participants who are of an advanced age, as well as anybody who may be technologically illiterate. These are areas in which conventional clinical trials are more advantageous. Which brings us to the second subject of this comparison.
2. Conventional Clinical Trial Characteristics
Conventional clinical trials are, as their name implies, more conventional. Therein lies their greatest advantage. They’re more tried and tested than DCT’s because they’ve been in use for much longer, and their strengths and weaknesses are very well documented.
Conventional clinical trials are also a tad more preferable in consent-gathering procedures. Particularly from a body language perspective, since body language may not be as visible on camera or during any remote signing process.
Because conventional clinical trials are currently the polar opposites of DCTs in terms of location-centricity, advantages that rely on location-centric operational procedures belong to conventional clinical trials. These advantages have already been mentioned above in that they are disadvantages for DCTs.
A higher interaction level between clinical trial staff and trial participants is possible with conventional clinical trials which are primarily carried out on-site. The significance of this increased interaction is an increase in trust and rapport, which facilitates better communication between trial staff and trial participants as well as greater compliance on the trial participants’ part. Both participants’ compliance, together with the clarity of communication between staff & participants, are important factors in the quality of data obtained from a study.
This location-centric approach also means greater recruitment of technologically challenged participants, which secures certain categories of demographic diversity for some studies, such as enough participants from a relevant age group. It also allows for a general clarity difficult to find in DCTs.
Conventional clinical trials are more than just location-centric, however. They are mostly urban-centric. Because clinical trials need a sufficient number of eligible participants, and because these participants need to spend extended amounts of time on-site, recruitment of participants tends to happen mostly in cities or large towns where the site of experimentation is located. This lack of geographic diversity in participants may affect the quality of data collected from a study.
Another significant challenge in conventional clinical trials is the lack of real-time data monitoring in some of them. If the process is not deliberately integrated and automated to enable data collection in real-time, the sponsors may rely on a monitor to visit distant sites once or twice a month to check data, not allowing for variation and fluctuation factors in data during that time.
By comparison, Decentralized Clinical Trials are usually set up with some degree of automation and process integration from the get go. This is why they tend to save some time, money, effort, and resources for sponsors. Generally speaking, if automation and integration are done correctly, the more processes are automated and integrated in a clinical trial (conventional or decentralized), the more time and cost-efficient it is. And the higher the quality of the data gathered is, to some degree. Of course, time efficiency is also a huge factor in cost efficiency.
Weighing both DCTs and conventional clinical trials in the balance, with obvious advantages and disadvantages for both, the question isn’t “which approach of conducting a clinical study is better than the other?” The question we should be asking is “which approach of conducting a clinical study is more suited to the subject of investigation?”
Because for the foreseeable future, demand for both approaches to clinical trials will continue. Of course, hybrid clinical studies that employ a mix of both, location-centric processes and decentralized procedures, exist specifically in order to fulfill the niche for clinical trials which require a dual approach to guarantee a higher quality of data. But that’s a topic for another day.