Opinion: Clinical Trials Should Be Accessible to Everybody
A lack of access, awareness, and trust have led to a lack of affordability, effectiveness, and inclusivity.
What is standing in the way between Americans and clinical trials?
There are 123,413 registered clinical trials in the United States1 with the majority of participants white males.1 Consequently, we lack the diversity to make medicines that work for everybody. Perhaps even more troublesome, just 1% of cancer patients are enrolling in clinical trials as a first course of therapy after diagnosis.2 So, what is keeping them out?
A lack of access, awareness, and trust has caused an extreme lack of inclusivity in medical science.
In terms of access, 70% of patients live more than 2 hours from a research site3 When the average clinical trial requires 11 visits,4 that can translate into thousands of dollars in childcare costs, lost wages, and travel expenses. For instance, the average cost for childcare by the time a trial is complete is estimated at $2365, and the average loss in a daily wage and incurred travel costs for a single visit is $2090.5 Geography makes trials cost-prohibitive to hundreds of thousands of individuals who may, otherwise, have no other treatment options.
Now consider these startling statistics: 85% of clinical trials fail to retain enough patients,6 37% are terminated before testing even starts because of under-enrollment,7 and 11% fail to recruit a single patient.8 Further, the 30% of patients who do sign up, drop out before the trial is complete.9
Trial inaccessibility stifles the development of life-altering medicines and contributes to their high cost. The slow-down costs trial sponsors between $600,000 and $8 million each day that a trial is delayed and can add $19,533 per lost patient (the average cost to recruit a new trial patient) to replace dropouts.10 Ultimately, this increases the cost of approved drugs, with consumers bearing the greatest burden.
The COVID-19 pandemic showed that it does not have to be this way. Forced to adopt alternative methods, digital innovations that had already been brewing across the life sciences industry became mainstream. Many investigators started leveraging cloud-based decentralized clinical trial (DCT) platforms, digital technologies, and wearable devices to bring trials to patients. And things are better. As use of decentralized components, such as eConsent, remote patient monitoring, and telemedicine, have increased, stoppages and trial delays have steadily declined. The results of a new GlobalData study report show that the rate of low accrual issues declined substantially to 19% in 2020 from 32% in 2011.11
Addressing Trial Awareness and Interest
Prior to the COVID-19 pandemic, most patients had very little understanding of how clinical trials work or how to find ones in which they would be eligible to participate. Now, trials are firmly in the public eye, and the average individual is talking about development timelines, how trials are being conducted and where, and the benefits and risks. Awareness is growing. However, there still are no streamlined ways for patients to search for available trials, and that must change. In addition, health care professionals must start proactively advocating and promoting trials to patients, especially as technology is making trials more accessible to everyone.
Decentralized, technology-enabled research is quickly becoming a patient favorite. In fact, of 3800 patients recently surveyed, 44% of whom had previous clinical trial experience, just 26% said that they prefer clinical trial procedures to be conducted at the trial site. More than one-third said that they prefer a hybrid approach, and nearly 60% would consider participating in a trial where all visits were conducted virtually.12
Given the greater accessibility and low patient burden associated with a decentralized approach to clinical trials, an increasing number of trial sponsors are embracing the move, improving patient recruitment, and helping democratize clinical research.
Takeda, for instance, announced that a year from now, 30% of its newly launched studies will have decentralized elements, meaning that some visits will either be moved from medical centers to easier-to-reach trial sites or virtual settings, or the studies will involve remote monitoring technology, according to Andrew Plump, MD, president of Takeda’s research and development arm.
In three years, Takeda aims to bring that to 100%, he said.13
Although drug-based interventional DCTs only experienced a 7% compound annual growth rate between 2014 and 2019, they jumped to 77% between the second halves of 2019 and 2020, according to data from more than 1000 trials.14
The bottom line is that DCTs are here to stay but will also evolve rapidly as the industry incorporates the learnings from 2021 into future protocol designs and as the clinical ecosystem expands to offer more localized points of access within patients’ communities. These local interfaces will make clinical trials more consumer-centric and part of daily life.
Decentralization Expands Clinical Care and Trust
The decentralization of clinical research is having a tremendous impact on trial access, cost, and efficiency, but that is just the tip of the iceberg. What if anyone, especially those not comfortable with technology or without access to reliable internet access, could access clinical trials from places they already know and trust, such as their local pharmacies or walk-in medical clinics?
There are 26,044 retail pharmacies across the United States.15 Patients visit their pharmacy an average of 35 times per year compared with just 4 visits to see medical providers.16 The move toward decentralized trials will get an adrenaline boost when augmented by local pharmacies and other community access points while improving enrollment, inclusivity, 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," Troyen A. Brennan, MD, MPH, executive vice president and chief medical officer of CVS Health, said in a statement.17
In May 2021, CVS Health announced an initiative to help facilitate clinical trials for investigational COVID-19 vaccines and treatments at many of its 9962 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 working with key technology providers in 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, health care providers, clinical research organizations, and study sponsors," Brennan said.
By allowing local pharmacies to become access points or supplemental investigator sites for clinical trials, 90% of Americans suddenly become within a 5-minute drive of a clinical trial.18 But it is not just about convenience and inclusivity; it is also about trust.
CVS Health, for instance, provides access to more than 85% of the US population, as well as 40% of vulnerable populations that live within a 5-mile radius of a CVS location. In addition, the CVS workforce is positioned to provide culturally appropriate care, as nearly half of CVS’ registered pharmacists and pharmacy technicians nationwide represent ethnic or racial minorities.
Patients who can engage with those who look like them and live in their communities are more likely to participate in potentially life-saving clinical trials. Not only do local pharmacies and other nearby points of access dramatically reduce the cost burden and time to trial participation, but they also help overcome the issues of lack of awareness and trust that act as barriers to underserved communities.
Further, pharmacists remain at the top of Gallup’s annual survey of professionals that rank the highest in honesty and ethics.19 Trust in a health care adviser is the key to ensuring continuity of treatment regimen and particularly crucial for apprehensive patients grappling with COVID-19 vaccination decisions and skeptics jaded by historic tragedies, such as the Tuskegee Syphilis Study of 1932. Believability, however fragile, increases when patients are seeking advice from familiar individuals they see at the grocery store or in the park outside the pharmacy.
And why stop at pharmacies? Thanks to modern technology, trial access points can be expanded virtually anywhere: community centers, local labs, minute clinics, schools, and more.
Leveraging software-as-a-service (SaaS) DCT platform technology, community locations can access the ancillary support they need to conduct trials at scale. Modular SaaS platforms are also easy to deploy and use, so pharmacies and other medical offices can spend more time with patients and less time worrying about maintenance, site setup, and tech training.
Below are specific ways a decentralized trial, supported by local pharmacies-as-sites, benefit drug development, patients, and sponsors:
Capture better clinical outcome assessments. Clinical outcome assessments that take advantage of new digital technologies can capture outcome assessments remotely and deploy innovative approaches, such as electronic diaries. This allows 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 5-mile radius of a patient’s home, decreasing any burden and increasing the likelihood of patient retention.
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, there is still no certainty that patients fully understand what they are signing up for, just because they sign their names. However, with a decentralized trial, electronic consent can be leveraged that includes interactive elements, Q&As, and video to help increase patient comprehension. Furthermore, patients can mark the sections they do not understand for telehealth review with their trial physician. The technology can also more easily accommodate local languages and regulations for geographic flexibility, with patients taking questions to local pharmacies to be answered in person by familiar faces.
Recruit patients at home. DCTs 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 patients with rare disease who are often more spread out across different geographies. Ultimately, sponsors can meet study enrollment targets faster and with fewer resources.
Bringing the On-Site Experience Close to Home
The potential impact of decentralized approaches to clinical research supplemented by trusted, community health care providers, such as pharmacies, is dramatic. Sponsors can save $640,000 to $940,000 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 US population can gain affordable, low-burden access to life-saving treatment trials while research becomes more representative of the entire population, ultimately, improving medical outcomes for everyone.
Modern technology is the bridge between the patients and pharmacists. Today, it is the retail pharmacy on 1 side of the bridge, but tomorrow it could be another point of access. It is exciting.
Together, we can give millions more access, making research more affordable, effective, and inclusive. 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 health, care by leveraging each other, existing retail infrastructure, and modern technology.
------------------------------------------------------------------
Sanskriti Thakur is the chief growth officer at Medable Inc, a decentralized clinical trial platform in Palo Alto, California.
------------------------------------------------------------------
References
1. Trends, charts, and maps. Clinicaltrials.gov. Accessed December 31, 2021. https://clinicaltrials.gov/ct2/resources/trends#LocationsOfRegisteredStudies
2. Hargreaves B. White males overrepresented in clinical trials. Outsourcing Pharma. January 27, 2020. Accessed December 31, 2021. https://www.outsourcing-pharma.com/Article/2020/01/24/White-males-overrepresented-in-clinical-trials
3. Anderson D, Fox J, Elsner N. Transforming the future of clinical development. Deloitte February 14, 2018. Accessed December 31, 2021. https://www2.deloitte.com/us/en/insights/industry/life-sciences/digital-research-and-development-clinical-strategy.html
4. Moore TJ, Heyward J, Anderson G, Alexander GC. 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. 2020;10(6):e038863.
doi:10.1136/bmjopen-2020-038863
5. Medable. Accessed December 31, 2021. www.medable.com
6. Decentralized clinical trials: are we ready to make the leap? Biopharma Dive. January 29, 2019. Accessed December 31, 2021. https://www.biopharmadive.com/spons/decentralized-clinical-trials-are-we-ready-to-make-the-leap/546591/
7. About us. Coalition for Clinical Trial Awareness. Accessed December 31, 2021. http://cctawareness.org/about-us/
8. Interview with Ken Getz: exploring challenges of clinical trial operations part 1. Cytel. April 5, 2018. Accessed December 31, 2021. https://www.cytel.com/blog/interview-kengetz-challenges-clinicaltrial-operations
9. Considerations for improving patient recruitment in trials. Clinical Leader. Accessed December 31, 2021. https://www.clinicalleader.com/doc/considerations-for-improving-patient-0001
10. Roth C. The real cost of clinical trials. Praxis. July 25, 2017. December 31, 2021. https://www.gopraxis.com/real-cost-clinical-trials/
11. Increased use of virtual trials has contributed to improved patient accrual rates. GlobalData Healthcare. August 12, 2021. December 31, 2021. https://www.pharmaceutical-technology.com/comment/increased-use-virtual-trials-accrual-rates/
12. Passut C. Selective use of decentralization methods best bet for most trials post-pandemic. CenterWatch. June 7, 2021. December 31, 2021. https://www.centerwatch.com/articles/25653-selective-use-of-decentralization-methods-best-bet-for-most-trials-postpandemic
13. Galvin G. Clinical trials are slow and expensive. leaders want that to change in 2022. Morning Consult. December 21, 2021. December 31, 2021. https://morningconsult.com/2021/12/21/clinical-trials-poll-2022/
14. Gao F, Solomon M, Roy A, Chaplin W. Why decentralized trials are the way of the future. Applied Clinical Trials. April 5, 2021. December 31, 2021. https://www.appliedclinicaltrialsonline.com/view/why-decentralized-clinical-trials-are-the-way-of-the-future
15. Pharmacies & drug stores in the United States. Ibis World. July 29, 2021. December 31, 2021. https://www.ibisworld.com/industry-statistics/number-of-businesses/pharmacies-drug-stores-united-states/
16. Gebhart F. Pharmacists want more time with patients. Drug Topics. March 18, 2019. December 31, 2021. https://www.drugtopics.com/view/pharmacists-want-more-time-patients
17. CVS Health introduces clinical trial services. CVS. News release. May 20, 2021. December 31, 2021. https://cvshealth.com/news-and-insights/press-releases/cvs-health-introduces-clinical-trial-services
18. Get to know your pharmacist. CDC. January 4, 2021. December 31, 2021. https://www.cdc.gov/heartdisease/pharmacist.htm
19. Reinhart RJ. Nurses continue to rate highest in ethics, honesty. Gallup Inc. January 6, 2020. December 31, 2021. https://news.gallup.com/poll/274673/nurses-continue-rate-highest-honesty-ethics.aspx
