What are Decentralized Clinical Trials and Why are They Here to Stay

#BHHSeries with Suvoda: Decentralized Clinical Trials Advance the Clinical Trial Experience

Recently, we launched another edition of the #BHHSeries in collaboration with one of our members, Suvoda, and DCT experts included Henk Dieteren, Clinical Supply Chain Solutions Consultant at Suvoda, Dr. Aneta Woroniecka-Osio, Senior Global Clinical Project Manager at Bayer and Andrea Zobel, Senior Director Personalized Supply Chain at World Courier.

Introducing Decentralized Clinical Trials

The FDA has adopted the term decentralized trials for any trial that does not follow a traditional site-centered clinical trial model and instead utilizes mobile technology, local healthcare providers, telemedicine, or any measure that modifies the traditional role of a site place in a clinical trial. It is all about going from the clinical site visit to the physical visits to the patient’s home and what is needed. Decentralized trials offer a patient-centric approach addressing various patient needs that often go unmet in traditional designs.

There are many ways to implement these DCTs. They can be fully decentralized or even a hybrid clinical trial – meaning a combination of site and home visits. This decentralization of the traditional model shifts the patient to the center, providing access to participation in the patient’s ecosystem rather than the traditional sites. This lessens the patient’s burden to be able to participate.

To be patient-centric, sponsors need to create a better patient experience throughout the life cycle of a trial. making trials more convenient implies one must put themselves in the patient’s shoes to understand the burden and the limitations that prevent or otherwise limit their participation. And when focusing on patient retention, decentralized clinical trials allow the collection of safety and efficacy data from the participants by using a range of digital technology that requires a minimum number of site visits.

Leveraging digital solutions will be important in creating a better experience. Some examples:

  • eCONSENT and electronic clinical outcome assessment, also known as eCOA, can help to increase engagement and comprehension of protocol for patients participating,
  • Telehealth visits facilitate communication between clinicians and patients to create trust and convenience on the patient level,
  • Wearables can serve to further facilitate convenient decentralized solutions for patients by reducing site visits,
  • Remote monitoring of clinical sites can provide greater efficiency at sites and the overall operation of a study by centralizing data across sites. This can only improve patients’ experience with clinical nurses and other team members as their study progresses.

DCTs solve healthcare’s last-mile challenges

Logistics is what we are talking about when discussing decentralized clinical trials – the direct delivery of the clinical trial supplies is challenging. Therefore, trials have to consider how to ensure they meet the concerned GMP and GCP requirements. Also, how to ensure the GDPR is met.

While technically, DTP can be used almost any time, there are, of course, a few scenarios that fit best. For example, suppose you look to rare diseases where subjects are hard to find or subjects that need to travel far from the sites. In addition, long study durations impact the subject’s retention and adherence to protocols. DTP mitigates these challenges.

The biggest challenge to DCTs is ensuring patient privacy throughout the process. While trials are conducted as blind studies, specific patient data is required to make an at home delivery. Therefore, it is essential that access to such private data is limited on a need-to-know basis, such as to the driver making the home delivery.

Decentralized trails are here to stay

Decentralized trials offer the next evolution in advancing the patient experience by making access to trail medications easier and less restrictive. This allows for a wider audience of trial participants resulting in greater protocol adherence and shorter trial periods. In today’s digital environment, DCTs are an essential part of digital health.

Do you want to know more? Watch the full episode of this #BHHSeries below, on our YouTube channel or contact Suvoda directly!