Academic medical centers (AMCs) have long been the home of cutting-edge clinical trials and medical interventions. Sixty percent (60%) of patients seek out AMC when they need to enroll in a clinical trial.New medicines provide hope to patients but require observation, data collection, and analysis. As a result, clinical trials have historically been limited to the AMCs. However, the rise of remote technology and the effects of the Covid-19 pandemic have changed that. The pandemic pushed research sites to embrace remote technology, and decentralized clinical trial (DCT) technology has also enabled AMCs to spread their expertise and infrastructure to local physicians who may have lacked the resources to perform clinical trials before. Since 72% of hospitals are now part of larger health systems, smaller clinics can assist with patient care. Academic medical centers can help local physicians and pharmacies to also engage in clinical research. Expanding clinical trials to community hospitals, pharmacies, and clinics benefits those sites and patients both. Patients who have been historically underrepresented in trials, including Black, Hispanic, and LGBTQ+ patients can participate. In addition, many people also have trouble reaching AMCs. More than 70% of the U.S. population live more than two hours away from an AMC, and many patients can’t afford to leave work or pay for childcare to reach appointments [1].
Community-based clinical trials can overcome some of the shortcomings and bolster AMC-based clinical trials. Community-based clinical trials are clinical trials conducted directly through community doctors and clinics rather than academic research facilities. They are designed to be administered through primary care physicians, community health centers, and local outpatient facilities. In 1986, the Community Consortium held the first such trials in the United States to determine the efficiency of preventive treatments after the onset of Pneumocystis pneumonia[2]. The trials give patients access to new medications and keep doctors involved with new developments in research. Community-based clinical trials are becoming prevalent in human-testing stage pharmaceutical research.
Industry-sponsored clinical trials are fraught with inefficiencies. Patient recruitment is challenging. U.S. investigators enroll two-thirds as many subjects into clinical trials as investigators in the rest of the world. Among U.S. investigators participating in a clinical trial, 27% fail to enroll any subjects. Investigator performance in the United States and the rest of the world is similar in that 75% of investigators fail to enroll the target number of subjects; also, 90% of all clinical trials worldwide fail to enroll patients within the target amount of time and must extend their enrollment period [3].Study timelines are typically extended to nearly double their original duration to meet desired enrollment levels for all therapeutic areas. In addition to delayed timelines, 37% of sites do not meet their enrollment target, while 11% of sites fail to enroll a single patient [4].
The concept of an Integrated Site Organization has been conceived as a novel business model to overcome some of these limitations. This concept is to bridge sponsors, and physicians, and patients together. This model can enable new community physicians to participate in clinical trials, thereby improving in-need patient access to cutting edge drugs and technologies. For clinical trial sponsors, this model could be used to expand access to a larger eligible patient pool and conducts trials in community settings with operational efficiency. Partnerships can be built with community physicians and digital technologies can be utilized to bring efficient, reliable, real-world clinical trial design and execution. An Integrated Site Organization can access the large, untapped patient population in the community practices. On-site personnel, standardized operating procedures, trial management software, and regulatory support can be integrated also. This concept can enable sponsors and CROs to look for new ways to create research sites that are operationally efficient and cash flow positive.
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[1] https://www.forbes.com/sites/forbestechcouncil/2021/08/18/addressing-the-clinical-trial-industrys-participation-problem-what-role-can-academic-medical-centers-play/?sh=50e5aef83af9
[2] Wikipedia “Community-based clinical trials” 2021
[3] Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. Washington (DC): National Academies Press (US); 2010
[4] https://trialfacts.com/data-doesnt-lie-part-l-clinical-trials-enrollment-forecasting-worth-it/