The healthcare industry, including clinical trials research, was forced to face and cope with some of the biggest challenges in the scientific field due to the pandemic. COVID-19 restrictions prevented patient recruitment, treatment, and site visits. Numerous clinical trials were paused or suspended due to lockdowns.
Thankfully, this prompted a new approach to clinical trials to come into the picture. Sponsor companies started implementing decentralized clinical trials and managed to solve many of the issues the pandemic had brought about. The new virtual method revolutionized the way clinical trials work. Most CROs that adopted the new approach have shown no signs of looking back even now that we’re nearing the end of the pandemic.
This article will cover the concept of virtual trials, revealing what’s so groundbreaking about them and discussing their benefits and the challenges they encompass.
What Are Decentralized Clinical Trials (DCT)?
Decentralized trials (DCT) are clinical trials that use digital technologies and processes to move the research from clinical research centers into patients’ homes and workspaces, doctors’ offices, and pharmacies. In that sense, they remove the burdens and challenges of site visits and in-person trial participation from patients. While giving them more freedom, virtual trials also allow patients to become more engaged in their treatment and more knowledgeable about the research itself.
Transition Into Decentralized Trials
Decentralized trials are not a new concept. They’ve been around for a while, but they were not common until trial developers decided to adopt the method prematurely due to the COVID-19 crisis. Some have adopted a fully virtual method, while others transitioned into the hybrid model that mixes elements from both site-based and decentralized trials. Either way, this patient-centric approach to clinical trials helped CROs work around lockdown guidelines, resume their research, and achieve quality results.
More than 70% of sponsor companies that never used the virtual approach before have now decided to implement it. Both industry leaders, such as Verily Life Sciences and Amazon Care have shown interest in adopting this method.
While the transition has not been easy, companies interested in using the decentralized method have had help. Non-profit organizations such as the Decentralized Trials & Resource Alliance (DTRA) and Digital Medicine Society (DiMe) have supported the accelerated adoption of the decentralized model and helped sponsor companies overcome the difficulties this process entails.
Moreover, numerous companies specializing in offering services that help drug developers adopt a decentralized approach have also appeared. Medable and Science 37 have become best-known in this sphere, but others like Obviohealth, THREAD, and Lightship are not lagging far behind.
Challenges of Decentralized Clinical Trials
We should note that the jump from traditional to decentralized created several challenges. The following list comprises the most important areas of concern regarding virtual trials.
Patient safety — Fewer visits to the research and clinical centers resulted in a rise in concern
Data privacy and security — Extensive use of technology, such as telemedicine, where data constantly flows from one device to another, increases data security risks
Data integrity — Decentralized trials capture data from numerous sources in real-time, so it’s harder to keep track, monitor, and ensure data integrity
Regulatory frameworks — Decentralized trials heavily depend on a regulatory framework that will centralize the way data and other information are collected, sent, received, and systematized
Benefits of Decentralized Clinical Trials
You’ll understand all the benefits of decentralized clinical trials compared to the traditional trial model. In fact, the new virtual model worked so well because the traditional model had already become outdated.
Clinical trials that used the traditional, site-based method have recently dealt with several issues. They’ve had problems with both patient recruitment and patient retention. Patients were not as inclined to enroll and stay in trials they knew would require giving up free time and taking time off work to make numerous site visits. Using the traditional trial model, CROs also had difficulties reaching patients from diverse age, racial, and class groups, which affected the research results.
Decentralized trials solved many of these issues. They’ve provided an improved patient experience through the leverage of technology. Virtual tools stopped patients from spending money and time on site visits. As a result, the patient enrollment rate rose, and the patient drop-out rate decreased.
The trial investigator and the researchers also benefited from this change. The use of tools such as eConsent, mHealth, wearables, telehealth, eCOA, and others reduced trial delays and costs. The virtual model helped the researchers monitor patients and collect and analyze data more efficiently and effectively.
Finally, the virtual trial model accelerated trial timelines, improved patient adherence to protocol, dosage requirements, and boosted data quality.
Real-World Evidence (RWE) and Patient-Centricity
As you can see, decentralized trials influenced many areas of clinical trial research. However, they are expected to make an even bigger impact on real-world evidence (RWE) and patient-centricity. The FDU and the 21st Century Cures Act support both areas, thus playing a key role in DCT.
The traditional trial model was not a favourite among the patients. As many as 34% of trial participants reported they would not recommend enrolling in clinical trials to others, according to GlobalData.
However, being patient-centric, decentralized trials can change that percentage. Their use of technology in remote patient monitoring will reduce the number of procedures the research requires and make participating in the study more convenient. It will also provide the researchers with real-time data that should improve the drug development process and eventually completely eliminate the use of control patients.
Conclusion
The pandemic-accelerated shift from traditional to decentralized clinical trials seems to have been a blessing in disguise. The new virtual approach to trials generated numerous benefits for both patients and researchers. It made trials more accessible, flexible, efficient, and effective. Experts say we can expect even better results once planned investment into partnerships with technology providers, advanced equipment, and more strategic in-house data management strategies are realized.
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