Due to the exponential increase in number and the impact of factors that have threatened clinical trial productivity since the pandemic, the dedicated research site model has become more critical than ever. In this article, I explore some of these critical factors.
By Torsten Sernau, Vice President of Medical Operations at FutureMeds
My exposure to the dedicated research site service model dates back to the early days of my clinical research career. In the mid-1990s, several major pharmaceutical sponsors were developing bisphosphonates for the treatment of postmenopausal osteoporosis.
As with any prophylactic intervention strategy, early administration during asymptomatic stages was crucial to prevent severe clinical outcomes, such as bone fractures. Consequently, large numbers of patients required DEXA scans and standardized X-rays to identify those with low bone density and morphological changes in the vertebrae.
Traditional sites quickly reached their screening capacities, while emerging dedicated research sites, such as CCBR in Denmark, effectively handled the high throughput of postmenopausal women for the diagnostic workup.
Simultaneously, two buses equipped with DEXA machines and labs toured Montana in North America, an area with a very low population density. Together, the Montana buses and dedicated research sites enrolled nearly 60% of the 5,000-patient cohort in this program - a fine combination of DCT elements and dedicated sites.
Factors that are threatening clinical trial productivity
Returning to the present, the dedicated research site model is more critical than ever before. Numerous factors are threatening clinical trial productivity, and their impact has intensified exponentially since the pandemic:
Healthcare appointment backlogs: Many healthcare systems are facing overwhelming backlogs, such as the 7.2 million patients on the NHS waiting list in the UK as of the end of 2022. (1)
Healthcare staff turnover: Healthcare staff turnover doubled during the pandemic in many markets, with delayed recoveries. (2)
Diminishing clinical trial capacity: Academic centres and hospitals are facing declining clinical trial capacity due to these staffing challenges. (1)
A record high in R&D spending: The number of compounds entering clinical development stages has tripled over the past 20 years. (3)
Increasing number of studies: The number of studies registered on trials.gov has risen from 325,000 in 2021 to over 440,000 in 2023. (4)
Protocols are becoming increasingly complex, as reflected in a 15-year CAGR of 14% for the number of data points. (3)
Expanding disease phenotypes: Disease phenotypes are segregating into more complex subtypes, and protocols are targeting largely undiagnosed indications (e.g., NASH, early-stage CKD, mental impairment as a precursor to dementia).
Given these trends, the drawbacks faced by traditional trial settings are evident. Fewer resources for more work cannot lead to positive outcomes. This is where dedicated research sites step in. They operate independently of routine care and effectively engage with patients throughout their clinical trial journey.
In the site business market, FutureMeds is well-positioned to offer superior enrollment productivity and high-quality standards. We have solutions for sourcing de-novo patients as well as for prevalent disease phenotypes through our multi-pronged recruitment model.
This foundation enables our site network to expand rapidly and provide improved solutions to our clients while our added home health service capabilities will further differentiate us from other site network organisations.
1 BMA Report/NHS 10/2022
2 University of Minnesota 04/2022
3 Pharmaprojects Tufts CSDD 2000 - 2020
Specialising in conducting clinical trials, FutureMeds is the 1st European Independent Dedicated DCT Site Network offering high levels of traditional and Decentralized Clinical Trial capabilities across the whole network and home nursing solutions in 18 European countries.
FutureMeds is driven by a purpose to connect a global healthcare community and help bring quicker access to life-changing medications and therapies to all those who need it worldwide.
FutureMeds’ Dedicated Research Site (DRS) teams serve as the company's service foundation. DRS team’s execution capabilities help pharmaceutical companies and contract research organisations accelerate study timelines, streamline processes, lower costs, improve data quality and ultimately help speed up drug development and patient access to new treatments.
FutureMeds @home, the company’s Decentralized Clinical Trial solution, provides pharmaceutical companies, contract research organisations and other partners with powerful insights, tools, teams & support, enabling them to simplify patient access to trials and boost recruitment, engagement and retention.
Through its acquisitions, partnerships and a strategic focus on patient experience, FutureMeds brings opportunities to diverse European patient populations to participate in clinical research under the medical supervision of qualified physicians and health care professionals.
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