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  • Writer's pictureYVAN LAMOUREUX

Decentralized Clinical Trials: Are We Ready to Make the Leap?

One of the biggest problems in the field of clinical trials is patient recruitment and retention. Many clinical trials never come to fruition because they fail to recruit and/or retain the necessary number of patients. As a result, the pharmaceutical industry actively seeks ways to resolve the problem and create a more sustainable clinical trial model.


Among the many potential solutions, one has stood out from the rest, drawn more attention, and shown better results — a decentralized model of clinical trials. This article will discuss the concept of decentralization concerning clinical trials, explore the benefits of this model, and explain how it works.


What Are Decentralized Clinical Trials?

Decentralized clinical trials (DCT) are clinical trials that allow patients to take part in them without visiting the clinical site. This model of clinical trials leverages modern technology and digital tools like telehealth visits, wearable medical devices, online patient diaries, eConsent, patient-driven health care apps, and so on.


These tools take a patient-centricity-based approach to healthcare and improve the overall patient experience. They help biopharma companies place the patients at the centre of the clinical trial they’re participating in, consider their perspective, and attend to their needs as much as possible.


Why Are Decentralized Clinical Trials a Good Solution?

For several reasons, the recruitment and retention of patients for clinical trials have been problem areas for the pharmaceutical industry. However, with virtual tools, decentralized clinical trials provide solutions to these and other issues trial sponsors face. Let’s take a look at all of the benefits this new clinical trial design brings to the table:


Better Patient Engagement

Many people choose to drop out or not even enroll in clinical trials because of the stigma attached to them. Potential patients generally hear and learn about the concept of clinical trials and how they work from the media. As a result, most create a negative image. On the other hand, some people are not aware that they can participate in trials, and others have little or no knowledge of the protocol, and so forth.


Decentralized clinical trials’ use of virtual tools can help solve these issues by:

  • Advertising trials and making more people aware that they can participate.

  • Destigmatizing trials by making more information about them readily available to potential patients.

  • Reaching and connecting with more potential patients.

Moreover, the same tools can provide participating patients with knowledge about the trial and their progress. With the help of technological tools, patients feel more autonomy over their participation in the trial and find security in the fact that they can track their journey and progress.


Increased Patient Participation

Besides the lack of knowledge and awareness about clinical trials, geographical distance seems to be one of the major issues that cause patient recruitment and retention problems. Namely, over 70% of patients live at least two hours away from clinical study centres or trial sites, according to studies.


Such distances make clinical trials unappealing and problematic to participate in, especially when regular visits to the site are necessary. As a result, many patients never enroll in the trial they’re considering or drop out soon after they’ve signed up for it.


Virtual clinical trials consider these concerns and needs and work hard to solve them. The use of virtual tools in these trials allows patients to participate without making frequent visits to the trial site. This way, decentralized clinical trials target a much larger pool of patients, including those who cannot travel due to their medical conditions, work obligations, or financial problems.


Reduced Workloads and Improved Results

Patients are the only ones that can benefit from the decentralized model of clinical trials. The fact that the system is patient-centred can work in favour of researchers that conduct the trial and, by extension, the trial itself and its sponsors.


Virtual tools use this new clinical trial design and base them on reduced CROs (Clinical Research Organization) workloads. That is, the virtual tools take the burden of data collection processes off of trial instigators and researchers and enable them to focus on other, more important areas of the trial. Such changes, in turn, save time and money the sponsors spend on the trial.


The same tools can also improve the trial’s results. Multiple studies conducted in the field show that virtual tools have helped patients provide more accurate and detailed information since they’ve been given more time to do so and knowledge on how to do it. On top of that, the virtual tools translate the information into data more effectively, organize it better — time-stamp and verify it — and keep it safe in one place.


So, decentralized clinical trials provide CROs with access to more continuous and less biased data. They also help the trial investigators and researchers analyze the data and create reports by investing less effort and time. Naturally, this also speeds up the overall product launch process and gives the trial sponsors an advantage over their competitors within the market.


Virtual Tool Implementation in Clinical Trials

As established, decentralized trials largely depend on tools like telehealth visits, video dosing confirmation, wearables, online patient diaries, data collection apps, and others. So, they must be as appealing and accessible to patients as possible. To be more precise, the virtual tools clinical trials leverage should be:

  • User-friendly — The device or app that the trial requires its patients to use should be intuitive and user-friendly. The patients shouldn’t have to go through a training course to use it independently. Moreover, they should know the tool’s exact purpose and understand the way it functions to benefit them.

  • Accessible — The tools the clinical trial uses should be easily accessible to its patients. The best options are apps and/or devices that work with well-known and commonly used platforms because the patients will be more likely to learn how to use them quickly and continue to do so regularly.

  • Versatile — Clinical trials shouldn’t overwhelm their participants with too many apps and/or devices. Instead, they should strive to use fewer virtual tools with multiple functions. This choice will allow the patients to use them more easily and effectively.

Conclusion

All in all, decentralized clinical trials offer a lot of perks to both stakeholders and patients. They establish a trial model based on patient-centricity and provide patients with a positive experience. In addition, they improve and speed up the recruitment process, reach a bigger patient pool, boost patient retention rates, reduce workloads for CROs, and accelerate the product launch.


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