What’s standing in the way between Americans and clinical trials?
Today, there are 123,413 registered clinical trials in the U.S.1 That means less than 4% of 328 million Americans are actively participating in clinical research, with the majority being white males. Consequently, we lack the diversity to make medicines that work for everybody. Perhaps even more troublesome, only 0.1% of cancer patients are enrolling in clinical trials as a first course of therapy after diagnosis.2 So, what’s keeping them out? For many, it comes down to access.
Currently, 70% of potential patients live more than two hours from a research site.3 When the average clinical trial requires 11 visits,4 that can translate into thousands of dollars in travel expenses, childcare costs, and lost wages. Geography makes trials cost-prohibitive to hundreds of thousands of people who may, otherwise, have no other treatment options.
Now consider these startling statistics: 85% of clinical trials fail to retain enough patients,5 37% are terminated before testing even starts because of under-enrollment,6 and 11% fail to recruit a single patient.7 Meanwhile, 30% of patients who do sign up, drop out before the trial is complete.8
Trial inaccessibility stifles the development of life-altering medicines and contributes to their high cost. The slow-down costs trial sponsors between $600k and $8 million each day a trial is delayed,9 and can add $19,533 per lost patient (the average cost to recruit a new trial patient) to replace dropouts. Ultimately, this increases the cost of approved drugs, with consumers bearing the greatest burden.
The COVID-19 pandemic showed us that it doesn’t have to be this way. Forced to adopt alternative methods, innovations that had already been brewing across the life sciences industry became mainstream. Many researchers started leveraging digital technologies, wearable devices, and cloud-based decentralized clinical trial (DCT) platforms to bring trials to patients. And, as use of virtual components, such as eConsent, telemedicine, and remote patient monitoring, has increased…trial delays and stoppages have steadily declined. A new GlobalData study report found that the rate of low accrual issues declined substantially to 19% in 2020 from 32% in 2011.10
Indeed, decentralized research is emerging as a patient favorite. In fact, of 3,800 patients recently surveyed (44% of whom had previous clinical trial experience), only 26% said they prefer clinical trial procedures to be conducted at the trial site. More than one-third said they prefer a hybrid approach, and nearly 60% would consider participating in a trial where all visits were conducted virtually.11
Given the low patient burden and greater patient comfort and accessibility associated with a decentralized approach to clinical trials, an increasing number of trial sponsors are embracing the move, improving patient recruitment and democratizing research. While drug-based interventional DCTs only experienced a 7% compound annual growth rate (CAGR) between 2014 and 2019, they jumped to 77% between the second halves of 2019 and 2020 after the onset of COVID-19, according to data from more than 1,000 trials.12
Decentralization Expands Points of Access
The decentralization of clinical research is having a tremendous impact on trial access, efficiency, and cost, and it may be just the tip of the iceberg. What if anyone, especially those not comfortable with technology or without access to reliable internet, could access clinical trials from places they already know and trust such as their local pharmacy or walk-in medical clinic?
There are 26,044 retail pharmacies across the U.S.13 Patients visit their pharmacy an average of 35 times per year compared to just four visits to see medical providers.14 The move towards decentralized trials could get an adrenaline boost if augmented by local pharmacies while improving trial access, enrollment, and retention.
“Traditionally, low patient enrollment, diversity, and engagement coupled with inconvenient trial sites, challenging study participation requirements, including the length of participation, show the need to improve the current model particularly in response to the COVID-19 pandemic,” said Troyen A. Brennan, MD, MPH, EVP, and Chief Medical Officer of CVS Health, in a statement.15
This May, CVS Health announced an initiative to help facilitate clinical trials for investigational COVID-19 vaccines and treatments at many of their 9,962 pharmacies nationwide. Using a specially designed digital model and screening protocols, CVS Health engaged more than 300,000 volunteers who met the study inclusion criteria for COVID-19 vaccine trial consideration and helped them connect to studies close to where they live. CVS Health is now working with key stakeholders across the clinical trial ecosystem to design and deliver innovative approaches to research and real-world evidence generation.
“Combining clinical trial expertise from across the CVS Health enterprise with our growing connection to the communities we serve, will help create a new clinical trial experience that works better for participants, healthcare providers, clinical research organizations, and study sponsors,” added Dr. Brennan.
By enabling local pharmacies to become access points, or supplemental investigator sites, for clinical trials, 90% of Americans suddenly become within a five-minute drive of a clinical trial.16 But it’s not just about convenience, it’s also about trust.
Pharmacists remain at the top of Gallup’s annual survey of professionals that rank the highest in “honesty and ethics.”17 Trust in one’s healthcare advisor is the key to ensuring continuity of treatment regimen and particularly crucial for apprehensive and skeptical patients grappling with COVID-19 vaccination decisions, among others. Believability increases when patients are seeking advice from the familiar white coat at their local pharmacy who they also bump into at the grocery store or in the park.
Leveraging software-as-a-service (SaaS) DCT platform technology, pharmacies can access the ancillary support they need to conduct trials at scale. Modular, SaaS platforms are also easy to deploy and use so pharmacies can spend more time with patients and less time worrying about tech training, maintenance, and site setup.
A decentralized trial, supported by local pharmacies-as-sites, benefits patients, sponsors, and drug development in several ways, including:
- Recruit patients at home: Decentralized clinical trials remove patient burden during the critical job of recruitment, setting the patient up for a better trial experience from the start. Remote screening can also be done at home anywhere in the world to incorporate rare disease patients who are often more spread out across different geographies. Ultimately, sponsors can meet study enrollment targets faster and with fewer resources.
- Enjoy flexible remote informed consent: Completing the informed consent process with patients in-person can be onerous, with many cases requiring upwards of 60 pages of documentation. In the end, just because they sign their name doesn’t mean the patient fully understands what they are signing up for. However, with a decentralized trial, electronic consent can be paired with interactive elements, video, and Q&As along the way to help increase patient comprehension. Furthermore, the patient can mark the sections they don’t understand for telehealth review with their trial physician. The technology can also more easily accommodate local regulations and languages for geographic flexibility, with patients taking questions to local pharmacies to be answered in person by familiar faces.
- Capture better Clinical Outcome Assessments: New digital technologies can capture outcome assessments remotely and deploy innovative approaches such as electronic diaries. This enables patients to capture their experiences in the moment and without the anxiety of speaking to a clinician. Wearable devices and sensors can track symptom data and digital endpoints continuously and can alert clinicians to any potential risk immediately. Pharmacists, likewise, supplement those assessments within the comfortable five-mile radius of the patient’s home, decreasing any burden and increasing the likelihood of patient retention.
Bringing the On-Site Experience Home
The potential impact of decentralized approaches to clinical research supplemented by trusted, community healthcare providers like pharmacies is dramatic. Sponsors can save $640 to $940K per trial by turning home settings and lower-cost sites into clinical trial access points. Patient enrollment time could be reduced by 65% to 70%. Most importantly, the remaining 96+% of the U.S. population can gain low-burden, affordable access to life-saving treatment trials and trials become more demographically representative of the entire population—ultimately, improving their efficacy for everybody.
Together, we can give millions more access, making research more inclusive, affordable, and effective. COVID-19, if nothing else, has forced the hands of the clinical research community, and we have discovered the possibilities for taking giant leaps forward in healthcare by leveraging modern technologies, existing retail infrastructure, and one another.
4. Original research: “Variation in the estimated costs of pivotal clinical benefit trials supporting the US approval of new therapeutic agents, 2015–2017: a cross-sectional study,” BMJ Open. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7295430.
10. “Increased use of virtual trials has contributed to improved patient accrual rates, says GlobalData,” GlobalData. https://www.globaldata.com/increased-use-virtual-trials-contributed-improved-patient-accrual-rates-says-globaldata.
11. “Selective Use of Decentralization Methods Best Bet for Most Trials Postpandemic,” CenterWatch. https://www.centerwatch.com/articles/25653-selective-use-of-decentralization-methods-best-bet-for-most-trials-postpandemic.
15. “CVS Health introduces Clinical Trial Services,” CVS Health. https://cvshealth.com/news-and-insights/press-releases/cvs-health-introduces-clinical-trial-services.