As we improve in medical science, we need to be able to conduct more clinical trials to keep pace. Yet trial delays continue to pose significant challenges. Most trials take place in academic medical centers, which are highly centralized and may not be easily accessible for a large portion of the population. Additionally, not all trials are conducted in all hospitals, so a trial may not be close to an eligible patient, which is a huge barrier to care.
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As a result, 85% of all clinical trials fail to enroll enough patients and 80% are delayed due to recruitment issues, creating potential losses of $600,000 to $8 million per day, CenterWatch research finds. . This already painful bottleneck will get worse over time if we do nothing about it. McKinsey notes: The decentralization of trials has emerged as an essential tool in this pursuit. It’s about bringing an increasing proportion of a trial’s business to patients rather than using the traditional paradigm of bringing patients to a trial site.
Decentralization has already been shown to streamline clinical trials, but it also has the potential to improve the broader healthcare ecosystem, including the patient and physician experience.
The case of decentralization
The decentralization of clinical trials aims to make participation more accessible and convenient for patients by reducing the need for extensive travel to specific trial sites. Although terms such as virtual, remote, home and siteless are used to describe this process, it is important to note that decentralization does not eliminate the involvement of healthcare professionals or physical contact with patients in in most cases. Here are some clarifications:
Virtual tryouts
Virtual trials take advantage of digital technologies and telemedicine to conduct certain trial activities remotely. Patients can interact with study coordinators, doctors or nurses through video calls or secure online platforms. This approach allows for remote monitoring, data collection and patient support, reducing the need for frequent in-person visits. However, physical contact with healthcare professionals may still be required for certain procedures, such as blood tests or imaging studies, which can be performed at local healthcare facilities.
Remote testing
Remote testing involves conducting testing activities outside of traditional testing sites, typically in patients’ homes or at local healthcare facilities. Patients can receive study drugs, complete self-assessments, and collect data using remote monitoring devices or digital platforms. Healthcare professionals remain involved in the process, providing remote advice, support and follow-up. However, occasional in-person visits may be required for certain assessments or procedures.
Home trials
Home trials take place primarily in patients’ homes, minimizing travel. Patients can receive study medications, complete self-assessments, and collect data under the guidance of healthcare professionals through remote communication channels. Home care providers or visiting nurses may also play a role in supporting patients during the trial and performing any necessary procedures or assessments at home.
Trials without site
Siteless trials take decentralization even further by completely eliminating the requirement for a physical trial site. Instead, trial activities are conducted using remote and digital approaches, and patients engage with healthcare professionals primarily through virtual means. Data collection and assessments can take place in patients’ homes or at local healthcare facilities, with the support of healthcare professionals.
Decentralized trials always involve healthcare professionals who provide advice, supervision and support to patients throughout the study. Although physical contact with healthcare professionals may be reduced, it is not completely eliminated, especially for procedures that require in-person assessments or interventions. The primary goal of decentralization is to make trial participation more convenient and accessible while maintaining the necessary oversight and care provided by healthcare professionals.
Eliminate the challenges of decentralization
As McKinsey also points out: The opportunities for decentralized clinical trials also bring new challenges to an industry often characterized by long cycle times and conservatism.
Getting enough people to sign up and complete a trial is a huge problem and bottleneck for bringing life-saving drugs to market. Biopharmaceutical companies spend more than $70 billion a year conducting trials worldwide, but patient recruitment is slow and almost always lags behind expectations.
In the typical ecosystem scenario, sponsors conduct clinical trials by selecting research clinics (“sites”) around the world and hoping that these sites can find and recruit the right patients. There are 2 major challenges: eligible patients often do not have access to the sites and ineligible patients register on the sites. Making clinical trials fully predictable and accessible is key to eliminating these challenges.
The key is to expand the patient pool by creating a large network of sites that can recruit/bring the trial to them. Tools are being created to access more patients using digital channels, so acquisition is, in many ways, resolved; however, there are several additional obstacles. First, patients need to be comfortable with this new paradigm. Second, smaller firms need to understand how to think about recruiting (a new workflow).
Enhancing the Greater Healthcare Ecosystem with Decentralized Clinical Trials
Decentralizing clinical trials improves the healthcare ecosystem by improving patient-centered care, expanding access to experimental treatments, fostering collaboration and knowledge sharing among healthcare providers, generating data and hard evidence, streamlining processes and reducing costs, and promoting innovation. and technology adoption. By bringing trial activities to patients’ local health care facilities, decentralization prioritizes convenience, inclusiveness, and personalized care, resulting in an improved health care experience. It allows a wider range of patients to participate in trials, increasing the diversity and generalizability of results.
Collaboration between health care providers is strengthened, leading to knowledge sharing and improved quality of care. Real-world data collected through decentralized trials offers insight into treatment effectiveness in real-world scenarios.
Simplified processes and cost savings benefit both patients and sponsors, allowing resources to be directed to new research. Integrating innovative technologies into decentralized trials drives their adoption in routine healthcare, which improves healthcare delivery and patient outcomes.
In summary, the decentralization of clinical trials has a positive impact on the healthcare ecosystem through patient centricity, increased access, collaboration, hard evidence, efficiency, cost savings and technological advancements.
About the Author
Vignesh Ravikumar joined Sierra Ventures in 2013 and focuses on investments in Enterprise SaaS, Vertical SaaS and Digital Health/Healthcare IT. Vignesh has a background in M&A transactions for enterprise software companies, having worked at AGC Partners, a Boston-based investment bank. Vignesh holds a BS in Management Science (cum laude) and a minor in Mathematics from UC San Diego. Outside of work, he is an avid golfer and a huge Golden State Warriors fan.
