As medicine advances, we need to be able to conduct more clinical trials to keep up. However, trial delays continue to pose significant challenges. Most trials take place in university medical centers, which are highly centralized and may not be easily accessible to large segments of the population. In addition, not all clinical trials are conducted in all hospitals, which may not be close to eligible patients, presenting a significant barrier to treatment.
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As a result, a CenterWatch study found that 85% of all clinical trials fail to recruit enough patients, and 80% are delayed due to recruitment issues, costing $600,000 to as much as $8 million per day. It is said that there is a possibility. This already painful bottleneck will only get worse over time if we do nothing. McKinsey points out: The decentralization of trials has emerged as an important tool in this pursuit. This includes providing patients with a greater proportion of clinical trial activities, rather than using the traditional paradigm of taking patients to the clinical trial site.
Decentralization has already been shown to streamline clinical trials, but it also has the potential to improve the broader healthcare ecosystem, including patient and physician experiences.
Need for decentralization
The decentralization of clinical trials aims to reduce the need for lengthy travel to a particular trial site and to make participation more accessible and convenient for patients. Terms such as virtual, remote, home and siteless are used to describe this process, but in most cases decentralization does not preclude the involvement of healthcare professionals or physical contact with patients. It is important to note that no Below are some explanations.
virtual trial
Virtual clinical trials leverage digital technology and telemedicine to conduct certain clinical trial activities remotely. Patients can interact with a study coordinator, doctor, or nurse via video call or her secure online platform. This approach enables remote monitoring, data collection and patient support, alleviating the need for frequent in-person visits. However, certain procedures that can be performed at your local health facility, such as blood tests and imaging tests, may still require physical contact with a health care professional.
remote trial
Remote clinical trials involve conducting clinical trial activities outside of traditional clinical trial sites, typically in the patient’s home or local medical facility. Patients receive the study drug, perform self-assessments, and collect data using remote monitoring devices and digital platforms. Medical professionals will continue to be involved in this process, providing guidance, support and monitoring remotely. However, from time to time an in-person visit may be required for certain assessments or procedures.
home trial
Home-based clinical trials are primarily conducted at the patient’s home, minimizing the need for travel. Patients can administer study drugs, perform self-assessments, and collect data as directed by medical professionals through remote communication channels. Home care providers and visiting nurses may also play a role in supporting patients undergoing clinical trials and performing necessary procedures and assessments in the home setting.
siteless trial
Siteless trials take decentralization one step further by completely eliminating the requirement of a physical trial site. Instead, clinical trial activities are conducted using remote and digital approaches, with patients engaging with medical professionals primarily through virtual means. Data collection and evaluation may occur at the patient’s home or local healthcare facility with the assistance of a healthcare professional.
Decentralized trials still involve medical professionals who provide guidance, supervision and support to patients throughout the study. Physical contact with health care professionals may be reduced, but not entirely eliminated, especially for procedures that require in-person evaluation or intervention. The primary goal of decentralization is to make participation in clinical trials more convenient and accessible while maintaining the necessary oversight and care by medical professionals.
Solving decentralization challenges
McKinsey also points out: The opportunity to decentralize clinical trials also brings new challenges to an industry characterized by long cycle times and conservatism.
Enrolling enough people and completing trials is a major challenge and bottleneck in bringing life-saving drugs to market. Biopharmaceutical companies worldwide spend more than $70 billion annually on clinical trials, yet patient enrollment is slow and often below expectations.
In a typical ecosystem scenario, sponsors select research clinics (“sites”) around the world and run clinical trials in hopes that these sites will be able to find and enroll suitable patients. There are two big challenges. Eligible patients are often unable to access the site, and non-eligible patients are registering with the site. Making clinical trials fully predictable and accessible is key to meeting these challenges.
The key is to expand your patient pool by creating a vast network of sites that can recruit patients and offer clinical trials. Patient acquisition is being solved in many ways as tools are being created to see more patients using digital channels. However, there are a few more hurdles. First, patients need to get used to this new paradigm. Second, small businesses need to understand how they think about hiring (the new workflow).
Improving Large Healthcare Ecosystems with Decentralized Clinical Trials
Decentralizing clinical trials to enhance patient-centred care, expand access to experimental treatments, promote collaboration and knowledge sharing among healthcare providers, generate real-world data and evidence, streamline processes and costs Reducing costs, fostering innovation, and improving the healthcare ecosystem. and the introduction of technology. By bringing clinical trial activities to the patient’s local point of care, decentralization prioritizes convenience, comprehensiveness and personalized care, resulting in a better healthcare experience. This will allow a wider range of patients to participate in trials, increasing the variability and generalizability of results.
Better collaboration among health care providers leads to knowledge sharing and improved quality of care. Real-world data collected in decentralized trials provide insight into treatment efficacy in real-world scenarios.
Streamlined processes and cost savings benefit both patients and sponsors, freeing up resources for further research. Integrating innovative technologies into decentralized clinical trials accelerates their adoption into routine care, leading to improved care 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, real-world evidence, efficiency, cost savings and technological advances.
About the author
Vignesh Ravikumar joined Sierra Ventures in 2013 and focuses on investments in Enterprise SaaS, Vertical SaaS and Digital Health/Healthcare IT. Mr. Vignesh has a background in his M&A deals for enterprise software companies, where he worked at AGC Partners, a Boston-based investment bank. Vignesh holds a Bachelor of Science (Hons) in Management Science and a minor in Mathematics from the University of California, San Diego. Outside of his job, he is an avid golfer and a big Golden State Warriors fan.