The emergence of decentralized clinical trials (DCTs), in the healthcare industry, was slow. However, as industry expert ObvioHealth explains, the Covid-19 pandemic situation accelerated the adoption of DCTs. At a time when the demand for novel, effective medicines and therapies was at an all-time high, there was an urgent need to conduct clinical trials in a manner that ensured the safety of participants from the perceived risk of infection.
DCTs differ from traditional clinical trials in the method of execution in terms of location. Instead of the site-centric way that earlier research was carried out, it may now be executed through more remote or virtual means such as telecommunications, assistance from local or mobile healthcare personnel, and the use of wearable technology and smartphone apps.
Today’s sophisticated tools and technology have greatly enhanced the effectiveness of clinical trials. It can be said that the way clinical trials are now conducted has changed forever. But what are the key elements of decentralized clinical trials?
The Key Elements
The DCT features a number of elements that distinguishes it from the erstwhile clinical trial model. Significant elements are as follows:
- DCTs are more Patient-Centric: If traditional clinical trials were necessarily site-centric, decentralised clinical trials can be considered patient-centric. Why? Because traditionally, patients had to take some trouble to participate in a clinical trial. Traveling to the trial site often involved time and expense. This was quite a burden for a participant who was coping with a health condition in addition to possibly managing work and home responsibilities. Such pressures often compelled patients to drop out of the trial. DCTs make patient participation less cumbersome and therefore more likely to continue. According to “Clinical Leader”, 85% of trials fail to retain enough participants for the desired minimum duration of the trial and thus fail to give a balanced and accurate result. DCTs which allow patients to participate with minimum trouble are more likely to attract and retain participants, culminating in a successful trial.
- Flexibility of Pattern: Every DCP doesn’t necessarily follow the same pattern. In fact, many clinical trials follow their own, particular hybrid pattern. A particular trial, for example, may require an initial visit to the clinical center by the participant and the follow-up may be executed remotely with the help of trial assistants. It may thus be said that incorporating more decentralized features into a clinical trial may have an overall, beneficial impact on the long-term results and success of the research.
- Technological Enhancement: Traditional centralized clinical trials were simple and straightforward, yet cumbersome. All the research and data collection took place on one site. DCTs are greatly enhanced by modern technical innovations. The accessibility of video calling enables virtual meetings with each patient to take place easily, with each participant sitting in his/her office or home. Virtual consultations can take place in a matter of seconds. Data can be submitted by participants to the trial center using smartphone apps and wearable technology, in an accurate and date-stamped manner. This can provide comprehensive information which enhances the effectiveness and accuracy of the data collected for the trial.
- Freedom from Boundaries: Site-centric clinical trials were limited to particular geographical areas. It’s not so in the case of DCTs. Traveling to clinical research sites put a strain on any participant living more than an hour away. Thanks to DCTs, distance doesn’t have to be an issue. Remote trials can be conducted across state boundaries and even across international borders. Of course, conducting such clinical trials may lead to issues concerning legislation on data collection in other states/countries’ jurisdictions. That’s why it’s important to check the legal aspects before embarking on any such projects.
What are the key elements of decentralized clinical trials?
The global healthcare industry, being highly regulated, adopted DCTs in a slow and cautious manner despite the speed of technological development. However, as mentioned earlier, Covid-19 changed everything and DCTs are now part of a post-pandemic world. Hopefully, these innovations will benefit clinical trials and bring about greater health and success, not only for patients but also for clinicians.
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