Over the past decade, the rise of this digital technology has transformed various sectors, from finance to healthcare. One particular area that has seen significant innovation is the realm of clinical trials. Traditionally conducted at centralized sites like hospitals or clinics, the latest trend is moving towards decentralized clinical trials (DCTs). Clinical trials are prospective biomedical research studies designed to evaluate medical, surgical or behavioral interventions in people and investigate novel approaches for the diagnosis and prevention / treatment of diseases. Recent scientific advances and the introduction of sophisticated clinical research platforms have enabled medical researchers and healthcare practitioners to cater to the evolving challenges within the pharmaceutical industry and deliver improved quality of care to patients. However, clinical trials are prone to significant delays, primarily due to various constraints, such as insufficient patient recruitment, inefficient study protocols and low patient retention. Considering the fact that clinical research in itself is a highly expensive process, such delays increase the expenditure of drug developers / sponsors to meet the desired medical outcomes. Over time, the healthcare industry needs an advanced technological solution to overcome such delays.
Decentralized clinical trials (DCTs) can be a solution to all the aforementioned challenges. These are the assessments, wherein the patients requirement for hospital-based trial sites are reduced or eliminated, allowing some or all of the trial-related activities to be conducted at their homes or other convenient locations other than the traditional clinical sites including, a local health care facility or laboratory.
What are Decentralized Clinical Trials (DCTs)?
Decentralized clinical trials (DCTs) present a novel approach of collecting safety and efficacy data from clinical trial participants, starting from study start-up through execution to follow-up. In such designs, the participants need not travel to a clinical research site or facility or a doctor’s clinic. Such trials make use of software applications, monitoring devices and online social media engagement platforms to conduct the complete clinical trial process, including recruitment, patient engagement, counseling, informed consent, electronic data capture, measuring clinical endpoints and adverse reactions, as per the patients’ comfort. Although decentralized trials still require the study site to accommodate support staff and invest resources in data gathering and analysis, these are more cost-effective as they do not require the traditional brick-and-mortar set-up of multiple investigation sites. In addition, these trials enable the elderly or patients living in far-off areas to actively participate in the trial, thus enabling the involvement of a highly diverse patient population. This arrangement offers opportunities for a more patient-centric approach, as patients can participate in the trial as per their convenience and without worrying about the need to travel to the study sites. In addition, decentralized trials enable researchers to capture and access data through remote patient monitoring devices in real time, thus improving trial designs that are based on accumulated data.
Modes of DCTs
The following figure presents the two modes of decentralized clinical trials offered by decentralized clinical trials companies.
Hybrid Clinical Trials: A hybrid mode of decentralized clinical trial combines remote patient monitoring data collection with in-person clinical visits, potentially reduces the stress on the participants while maintaining a vital personal connection. While some appointments in a clinical trial are essential, others are simply standard follow-ups to oversee clinical outcome assessments. These non-essential visits can be reduced with remote check-ins with the help of secure telemedicine platform.
Fully Virtual Clinical Trials: Fully virtual DCTs, also known as site-less approach, are entirely technological in nature eliminating the requirement of face-to-face contacts, and physical locations. The main aim of such trials is to remove participation barriers by virtually connecting study volunteers with researchers and healthcare professionals.
Applications Offered By Decentralized Clinical Trials (DCTs)
Decentralized models for trial conduct are known to offer numerous applications. The following figure presents the applications offered by decentralized clinical trials companies.
Increased Patient Enrollment: Innovative technological solutions enable trial sponsors to achieve maximum patient enrollment and minimize patient attrition rates.
Reduced Trial Delays: The ease of participation in decentralized trials gives sponsors access to a wider patient pool with an improved retention rate, resulting in reduced trial delays.
Enhanced Risk Assessments: Decentralized clinical trials hold the potential to minimize trial failure risk by allowing investigators to study data generated from monitoring devices in real-time.
Lower Capital Investments: In contrast to traditional clinical trials that need a large number of study sites, decentralized clinical studies need significantly less capital investment.
Challenges with Decentralized Clinical Trials (DCTs)
Although decentralized clinical trials highlight various challenges associated with traditional ways of clinical trials, however, there are certain limitations which have deterred their industry wide adoption.
The following figure presents the challenges associated with decentralized clinical trials.
Data Security: When firms employ decentralized trial methods, one of the most pressing operational concerns is ensuring compliance. Although remote patient monitoring data collecting can enhance patient compliance, it does impose significant issues in other areas, such as data privacy and authentication.
Data Privacy: As data is obtained from diverse sources, there is an extensive requirement for effective data security systems. Any type of data breach can compromise the entire study and leads to significant losses for innovative drug companies. In fact, according to the IBM report, published in 2022, the healthcare industry on an average incurs losses worth USD 10.1 million due to data breaching and cyberattacks.
Technology Literacy: Decentralized trials completely rely on advanced technologies to extract and analyze meaningful data. This demands the recruitment and retention of skilled employees with the necessary technical knowledge.
Data Integrity: Ensuring that data from various devices is accurate and consistent can be a challenge.
The Future of DCTs
There are several service providers (more than 70% of service providers are headquartered in North America) offering services related to decentralized clinical trials. These decentralized clinical trial companies offer an innovative and novel approach to address several challenges associated with conventional trials, including patient recruitments, retentions, site specific studies, electronic data capture and data managements. Decentralized clinical trials (DCTs) companies provide more patient-centric and thus have reduced clinical drug development timelines. This has also helped in addressing some of the major challenges such as high capital investments, required for the development of pharmaceutical products. Moreover, with such technological advancements, it becomes easier to collect, transfer, and store electronic data. Patients and providers are becoming more proficient and relaxed with telemedicine.
It is worth noting that in order to continue clinical research parallel to COVID related restrictions, the US FDA guidelines released in March 2020, allowed sponsors to conduct virtual visits, remote patient monitoring, and telephonic interviews. The adoption of virtual / decentralized approach by pharmaceutical companies and clinical research organization is believed to alter the trends in the clinical research industry. Owing to this, a huge shift in the acceptance of decentralization in clinical trials can be witnessed, with around 50% increase in the virtual and decentralized trial initiations since 2020. Considering the benefits and the increasing demand for decentralized clinical trials, as well as the pace of innovation in this field, many decentralized clinical trials companies are actively working on its service portfolio, and thus the market is likely to experience substantial growth in the near future.