As medical science advances, we need to be able to conduct more clinical trials to continue. However, trial delays continue to pose significant challenges. Most trials are conducted in academic medical centers, which are highly centralized and inaccessible to the general public. Additionally, not all trials are conducted in all hospitals, so the trial may not be in close proximity to an eligible patient population, which is a major barrier to care.
As a result, 85% of all clinical trials fail to recruit enough patients and 80% are delayed due to recruitment problems, which can lead to a loss of $600,000 to $8 million per day, according to a CenterWatt study. This already painful bottleneck will only get worse if we don’t do something about it. McKinsey says: Experimental decentralization has emerged as a critical tool in this search. Rather than traditionally bringing patients to the trial site, it involves adding trial activities to patients.
Decentralization has already been shown to streamline clinical trials, but it has the potential to improve the broader healthcare ecosystem, including the patient and physician experience.
Decentralization in clinical trials aims to make participation more accessible and convenient for patients by reducing 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. Here are some explanations:
Virtual trials use digital technologies and telemedicine to perform certain trial activities remotely. Patients can interact with study coordinators, physicians, or nurses via video calls or secure online forums. 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 is still possible for some procedures, such as blood tests or imaging studies, which may be performed at local health care facilities.
Remote trials involve conducting trials outside of traditional trial sites, typically in patients’ homes or local health care facilities. Patients can receive study medication, self-assess, and collect data using remote control devices or digital platforms. Healthcare professionals are involved in the process, providing guidance, support and remote monitoring. However, occasional in-person visits may be required for certain assessments or procedures.
In-home tests are performed primarily at patients’ homes, reducing the need for travel. Patients can receive study medication, self-assess and collect data from healthcare professionals via remote communication channels. Home health care providers or nurses may play a role in supporting patients during the trial and supporting important procedures or assessments in the home environment.
Siteless testing takes decentralization to another level by completely eliminating the need for a physical testing location. 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 be done in patients’ homes or local health care facilities with the support of health care professionals.
Decentralized trials still involve healthcare professionals who provide guidance, monitoring and support to patients during the study. Although physical contact with health care professionals may be reduced, it will not be completely eliminated, especially for procedures that require in-person assessments or interventions. The main objective of decentralization is to make trial participation more convenient and accessible while maintaining the necessary control and care provided by healthcare professionals.
Avoiding the challenges of decentralization
According to McKinsey: Opportunities to decentralize clinical trials bring new challenges to an industry known for its often long cycle times and conservatism.
Enrolling enough people and completing trials is a huge pain and hurdle to moving life-saving drugs to market. Biopharma companies spend more than $70 billion a year on trials worldwide, but patient enrollment is slow and always behind expectations.
In a typical ecosystem, sponsors conduct clinical trials by selecting research clinics (“sites”) around the world and hope that these sites can find and enroll appropriate patients. There are 2 main challenges: Eligible patients often cannot access the sites and ineligible patients are registering on the site. Making clinical trials fully predictable and accessible is key to overcoming these challenges.
The key is to expand the pool of patients by creating a wide network of sites to recruit/bring the test to them. Tools are being created to get face to face with more patients using digital channels, so acquisition is solving in many ways; However, there are several additional obstacles. First, patients must be comfortable with this new paradigm. Second, small practices need to understand how to think about recruitment.
Improving the larger health care ecosystem with decentralized clinical trials
Decentralization of clinical trials improves the healthcare ecosystem by promoting patient-centered care, expanding access to experimental treatments, enhancing collaboration and knowledge sharing among healthcare providers, generating real-world data and evidence, streamlining processes and reducing costs, and promoting innovation. and technology adoption. By bringing trial activities into patient-centered healthcare spaces, decentralization prioritizes convenience, inclusion, and personalized care, resulting in an improved healthcare experience. It allows a wider range of patients to participate in trials, increasing diversity and generalizability of results.
Collaboration among healthcare providers is improved, leading to knowledge sharing and improved care. Real-world data collected in randomized trials provide insights into treatment effectiveness in real-life situations.
Streamlined procedures and cost savings benefit both patients and sponsors, allowing resources to be directed toward more research. The integration of innovative technologies in decentralized trials encourages their adoption in routine healthcare, leading to better healthcare delivery and patient outcomes.
In summary, the decentralization of clinical trials through patient centricity, increased access, collaboration, real-world evidence, efficiency, cost-effectiveness, and technological advancement will have a positive impact on the healthcare ecosystem.
About the author
Vignesh Ravikumar joined Sierra Ventures in 2013 and makes investments in Enterprise SaaS, Vertical SaaS and Digital Health/Healthcare IT. Vignesh has experience working at Boston-based investment bank AGC Partners in M&A transactions for enterprise software companies. 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.