Clinical Trials: To Decentralise Or Not To Decentralise?

The Rise of Decentralized Clinical Trials

Clinical trials are a vital tool in medical research. Modern technology advancement has enabled a significant rise in off-site health monitoring so that many trials can now collect data outside medical centers. These are known as decentralized clinical trials (DCTs).

Types of Decentralised Trial

Traditionally, clinical trials have taken place in medical centers or within an academic research center. This approach requires patients to travel to a specific site where healthcare professionals can complete all relevant medical tests and record data. Over time, more sponsors began to ask patients to input their own data, sometimes using electronic devices, without a face-to-face visit.

A typical example of a decentralized approach is the use of electrical and smartphone technologies to return patient data. Virtual consent forms are now widely used, on-site and off-site, to recruit participants for many trials and health studies.

Telemedicine is another popular DCT approach, with patients speaking to doctors over the telephone from the comfort of their homes. The development of camera phones makes sending images more possible, while improvements in virtual communication also allow healthcare professionals to see each patient. This way, a virtual appointment can be a far more authentic experience.

Digital devices can also record and send data without further action from the participant. Glucose monitoring, activity trackers, and other implanted electrical apparatus, such as pacemakers, can record, process, and submit information directly to medical centers.

Home visits can also support DCT approaches, especially in phlebotomy or providing medication.

The Benefits of Decentralization

From a participant’s point of view, it is easy to see the advantages of a decentralized approach. Reducing the number of visits to a medical center saves a great deal of time and money, particularly when that center is situated far from home. Removing the distance barrier also improves recruitment by making participation in the program more attractive. In addition, more participants add diversity and can improve the accuracy of data for medical research.

Similarly, the methods used to monitor and store data in DCT approaches are typically non-invasive, allowing the subject to continue their daily lives as they would normally. Therefore, data is therefore likely to be more diverse and far more reliable than running tests in the controlled environment of a medical center.

The Impact of the Pandemic on Decentralization

While the percentage of DCTs has been increasing over time, 2020 saw a sharp rise in these approaches.

DCTs in the Post-COVID Era

Reduced mobility and lockdowns during the pandemic brought significant challenges to the industry; patients could not travel to trial sites or keep appointments. Following an initial decline in the number of trials, many sponsors quickly adapted to design solutions that would, in some way, bring the trial to the patient in their own homes. Many of these adaptations have proved so successful that they are now very likely to continue.

Videoconferencing and remote monitoring enabled continued trials during the pandemic and improved the services offered. Many patients reported increased satisfaction and a better quality experience. Care professionals have also noted that drug delivery saves patients time and ensures equitable access to medication for everyone involved in the study.

Overall, being able to live life as normally as possible while participating in a clinical study improves the experience for participants. There is also a very positive impact on recruitment and retention. Van Dorn points out that many studies have seen even the most motivated participants drop out due to the burdens of site-based trials (“COVID-19 and readjusting clinical trials. Lancet. 2020;396:523–524” [Google Scholar]). Patients find the cost of lost time, missed work, and travel expenses becomes too much as the trials continue.

Unsurprisingly, decentralized clinical trials recovered more quickly from any adverse effects of the pandemic than site-based designs. Moving forward, it seems clear that the future success of clinical trials depends on including at least some degree of a decentralized approach.