All over the world, laboratories develop drugs & therapies that bring life-changing benefits to patients. Before administrating them to patients, these drugs and therapies undergo multiple trials and approvals to ensure efficacy, dosage, and efficiency and are checked for side effects and any potentially harmful impact on the human body.

Traditionally, these trials were conducted in a closed setup at a research site with the help of academia and hospitals, where subjects are tested in various pre-conditions, doses, etc. However, the COVID-19 pandemic has disrupted many clinical trials causing delays in releasing potentially beneficial therapeutics to patients in need. Hence, the world is moving towards the decentralization of clinical trials, which is further spurred by technological advancement.

What is a Decentralized Clinical Trial (DCT)?

Despite many difficulties, a good side-effect of the pandemic is the swift adoption of virtual interactions between physicians and patients to provide continuity of care. This increased adoption of virtual interaction, healthcare, and monitoring is paving the way for DCTs. Industry leaders and experts define decentralized clinical trials in multiple terms, including virtual, home, remote, and siteless. However, the end goal remains the same – making clinical trials easier for patients by reducing or eliminating the need to travel to specific sites while improving the confidence in trials & data.

DCTs, also called virtual studies, are less dependent on traditional research facilities or specialist intermediaries for data collection. In DCTs, CROs leverage virtual tools, such as telemedicine, sensory-based technologies, wearable medical devices, and patient-centric virtual healthcare interfaces, and ensure direct delivery of study drugs and materials to patients’ homes. In a fully decentralized clinical trial, patient onboarding, delivery, the administration of study drugs & therapies, and the collection of trial outcomes are carried out without involving in-person contact between the study team and the patient/subject.

How is Technology Playing a Crucial Role in Improving the Adoption of DCTs?

The widespread adoption of DCTs is spurred by enhanced internet connectivity, real-time video conferencing, smartphone health applications, and remotely connectable health monitoring devices that are becoming more accurate, practical, and affordable. DCTs have reduced drop-out rates, improved study effectiveness, and ultimately gotten life-altering drugs to market faster.

• Drug distribution & management– In centralized clinical trials, drugs are shipped to trial sites that centrally manage and maintain them. However, in DTCs, we aim to ship them to the patient’s home, which brings greater complexity and risk in clinical trials, both to the subject and the integrity of the trial. Hence, CROs & trial sites need to provide an assurance of drug stability, prevent unauthorized access, and find methods to detect tampering and temperature tracking. CROs and trial sites can leverage GPS and IoT-enabled vehicles to track the drugs/medicines & ensure proper environmental conditions, and blockchain technology to prevent unauthorized access and detect tampering.
• Drug Adherence & Monitoring – In DCTs, CROs need to create a robust mechanism to record the administration of drugs, continuously monitor, and effectively communicate between the storage system and the drug source to provide timely refills and prevent study interruptions. Multiple solutions like real-time video conferencing, mobile apps, and wearables can be used to improve drug adherence, continuous monitoring, and communication between subject & trail sites or CROs.
• Security & privacy –DCTs require data collection from multiple devices which are then transmitted to the central location. In such cases, reliable cybersecurity systems are crucial. Protecting patients’ private information stored on connected devices is paramount and is achieved through a combination of different technologies e.g. cloud-enabled solutions, following regulatory compliance like HIPPA, etc.
• Data-driven insights – CROs have greater flexibility in DCTs in terms of coverage and sample size. A greater pool of subjects, chosen scientifically, enables or produces large amounts of data. This data can be collected continuously or periodically based on the nature of the study. Collected data can be transformed, and further insights can be drawn, leveraging AI, ML, and other advanced analytics solutions.
• Adverse event management –DCTs are basically siteless or conducted virtually and require quick action in case of an adverse reaction, considering the subject may be located at a distance or in rural areas. Hence, advanced connected solutions or products can be leveraged to connect patients, trail sites, ambulance services, and hospitals.

Key benefits of decentralization of clinical trials

• Quicker patient onboarding – DCTs are powered by virtual technologies that don’t require in-person visits in most cases, hence, patients/subjects are readily available to participate in the study. Easy-to-use smartphone apps, wearables & other medical devices enable patients to collect & monitor data from wherever they are. It makes their life easy by reducing regular visits to trial sites for data, guidance, and other discussions.
• Improved participation diversity –Centralized trials are usually focused on limited areas, or sponsors need to spend a lot in case they want to cover a larger population. However, now CROs have a much wider pool available as subject recruitment, medication, drug administration, and data collections are virtual, and they can cover a larger population located at a distance.
• Improved patient engagement –Patient awareness has improved significantly, and technology plays a key role. Now, patients are aware of basic medical terms, various diseases, and treatments. Aware and engaged patients ensure accurate data collection that augments the authenticity of the study.
• Data quantity and reporting –In DCTs, CROs collect various health-related data from a diverse set of populations, leveraging technology such as wearables, apps, and smartphones to keep data organized and safe. This data collected from a real-world setting is more likely to deliver bias-free insights.

Decentralized trials exist in many forms and shapes. Many trials are not likely to be fully virtual but still leverage “virtual” or “at-home” elements. Now, CROs and drug manufacturers have started moving from Centralized to Hybrid or fully decentralized trials based on the needs of the trials.

How can Brillio help?

Brillio is a leading player in this domain, and we have our own blockchain solution called ‘Smart Clinical Trials’ to help CROs to expedite their clinical trials. We are also working with multiple CROs across the industry and building solutions compatible with modern wearables to improve data collection, monitoring, and adverse event management leveraging our extensive Life Sciences domain expertise, engineering capabilities, and product-centric mindset.