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As we get better at medical science, we need to be able to run more clinical trials to keep up. Yet trial delays continue to pose significant challenges. Most trials are held in academic medical centers, which are very centralized and may not be easy for large chunks of the population to access. Furthermore, not all trials are run at all hospitals, so a trial may not be near a qualifying patient, which is a huge barrier to care.

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As a result, 85% of all clinical trials fail to recruit enough patients and 80% are delayed due to recruitment problems, creating potential losses of $600,000 to as high as $8 million per day, according to a CenterWatch study. This already painful bottleneck will become even worse over time if we dont do something about it. McKinsey notes: Trial decentralization has emerged as a critical tool in this pursuit. It involves bringing an increasing proportion of a trials activities to the 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 health care ecosystem, including the patient and physician experience.

Decentralization in 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's important to note that decentralization does not eliminate the involvement of health care professionals or physical contact with patients in most cases. Here are some clarifications:

Virtual trials leverage digital technologies and telemedicine to conduct certain trial activities remotely. Patients may interact with study coordinators, physicians, 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 health care professionals may still be required for certain procedures, such as blood tests or imaging studies, which can be conducted at local health care facilities.

Remote trials involve conducting trial activities outside of traditional trial sites, typically in patients' homes or local health care facilities. Patients may receive study medications, perform self-assessments, and collect data using remote monitoring devices or digital platforms. Health care professionals remain involved in the process, providing guidance, support, and monitoring remotely. However, occasional in-person visits may be required for certain assessments or procedures.

Home trials take place primarily at the patients' homes, minimizing the need for travel. Patients may receive study medications, perform self-assessments, and collect data as guided by health care professionals through remote communication channels. Home health care providers or visiting nurses may also play a role in supporting patients during the trial and conducting necessary procedures or assessments in the home environment.

Siteless trials go a step further in decentralization by eliminating the requirement for a physical trial site altogether. Instead, trial activities are conducted using remote and digital approaches, and patients engage with health care professionals primarily through virtual means. Data collection and assessments may occur in patients' homes or local health care facilities, with the support of health care professionals.

Decentralized trials still involve health care professionals who provide guidance, oversight, and support to patients throughout the study. While physical contact with health care 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 health care professionals.

As McKinsey also points out: The opportunities for decentralizing clinical trials also bring new challenges to an industry often characterized by long cycle times and conservatism.

Getting enough people enrolled and completing a trial is a huge pain point and bottleneck for moving life-saving drugs to market. Biopharma companies spend more than $70 billion annually running trials globally, yet patient enrollment is slow and almost always behind expectations.

In the typical ecosystem scenario, sponsors run clinical trials by selecting research clinics (sites) around the world and hoping these sites can find and enroll appropriate patients. There are 2 major challenges: eligible patients often dont have access to the sites and ineligible patients are enrolling at the sites. Making clinical trials completely predictable and accessible is the key to eliminating these challenges.

The key is to broaden the pool of patients by creating a vast network of sites that can recruit/bring the trial to them. Tools are being created to get in front of more patients using digital channels so acquisition is, in many ways, being solved; however, there are several additional hurdles. First, patients need to be comfortable with this new paradigm. Second, smaller practices need to understand how to think about recruiting (a new workflow).

The decentralization of clinical trials improves the health care ecosystem by enhancing patient-centered care, expanding access to experimental treatments, fostering collaboration and knowledge sharing among health care providers, generating real-world data and evidence, streamlining processes and reducing costs, and promoting innovation and technology adoption. By bringing trial activities to patients' local health care settings, decentralization prioritizes convenience, inclusivity, and personalized care, resulting in an improved health care experience. It allows a broader range of patients to participate in trials, increasing diversity and generalizability of results.

Collaboration among health care providers is enhanced, leading to knowledge sharing and improved quality of care. Real-world data collected in decentralized trials offer insights into treatment effectiveness in real-life scenarios.

Streamlined processes and cost savings benefit both patients and sponsors, enabling resources to be directed towards further research. The integration of innovative technologies in decentralized trials fosters their adoption in routine health care, leading to improved health care delivery and patient outcomes.

In summary, decentralization of clinical trials positively impacts the health care ecosystem through patient-centeredness, increased access, collaboration, real-world evidence, efficiency, cost savings, and technological advancement.

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 Math from UC San Diego. Outside of work, he is an avid golfer and a big Golden State Warriors fan.

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How the Decentralization of Clinical Trials Can Transform Health Care - Pharmacy Times