- Enrollment timelines are a huge challenge for clinical trial successes.
- Moving towards decentralized clinical trials can help alleviate some of those challenges, but the implementation comes with its own hurdles.
- Learning to incorporate real-world data and real-time tracking into your clinical trial processes can set up your decentralized trial for success.
Biopharma companies began to embrace hybrid decentralized trials before the pandemic. However, the era of COVID-19 has accelerated the adoption of decentralized trial studies — out of necessity.
There is a lot of discussion in the industry around whether or not decentralized trials will stay after the pandemic. In a survey by Oracle Health Sciences, 76% of respondents indicated that the pandemic accelerated their adoption of decentralized clinical trial methods.
“The pandemic will have a profound and lasting effect on clinical trials,” said Henry McNamara, senior vice president and general manager, Oracle Health Sciences. “The survey results illustrate how quickly the industry has pivoted and adopted new approaches, such as decentralized clinical trial methods, to keep clinical research going in these unprecedented times. Fortunately, our technology supports this change today and is designed to carry the industry forward.”
Due to the ability to increase patient enrollment and engagement, we would argue that decentralized clinical trials will become increasingly common after the pandemic. Based on our experiences, this article will help your company understand the critical steps required to prepare today by incorporating advanced data into your recruiting processes.
Transitioning from Traditional to Decentralized Clinical Trials
Traditional clinical trials take 10-12 years on average with only a 10 percent success rate. According to Deloitte, the “growing length of the clinical trial cycle was arguably the most pressing challenge for clinical development” in 2019.
Underneath the duration of traditional clinical trials lies a bigger problem: the increasing complexity of recruiting patients. Recruitment failure exacerbates the worrisome length of clinical trials and contributes to overall failure rates.
Several factors can limit patient recruitment, including:
- • A mismatch of patients – clinical trial companies are often not equipped to match patients adequately
- • Frequent clinic visits – approximately 70% of potential volunteers live more than two hours away from a clinical study site
These limitations have led to 18 percent of patients dropping out after enrolling and 80 percent of all trials not meeting enrollment timelines.
Rosamund Round, Vice President, Patient Innovation Center at PAREXEL explains, “It’s no secret that the pharmaceutical industry is in crisis and the current clinical trial model is unsustainable.”
Clinical trial companies need better patient recruitment strategies to achieve better trial success rates.
Decentralized Clinical Trials: A Potential Solution for Improving Patient Recruitment
Decentralized clinical trials have significant benefits over traditional clinical trial models, including:
- • Patients do not need to travel to the site of the clinical trial as often, if at all. Patients can participate in clinical studies from the comfort of their homes. In this era of virtual medicine, clinical trials must align with what is gradually becoming the new normal.
- • The study can be expanded to reach study volunteers who would have been unavailable under more traditional clinical trial protocols. Patients who normally find it difficult to participate in trials due to underlying medical conditions or barriers to access can do so now.
How to Prepare for Decentralized Clinical Trials
To achieve better patient matching, you need smart patient recruitment tools that can help you overcome the challenges of recruiting for decentralized clinical trials.
Mohan Prasad, Executive Director of Digital Operations at Covance explains, “As the role of the traditional CRO shifts into that of a digital and data-enabled partner, it’s imperative to have an operational framework that leverages our core competencies of drug development, with the nimbleness of a technology-enabled approach. Only in this way can we combine the twin imperatives of “diverse patient-centric trials” and “better results, faster” that are at the core of the [decentralized trials] promise.”
Decentralized trials will produce superior results when equipped with the right technologies, including a data-driven approach for recruiting and real-time tracking of patient data.
Use a Data-Driven Approach for Recruiting
Approximately 80 percent of clinical trials are delayed due to recruitment issues. Also, 16 percent of protocol amendments occur due to the poor choice of inclusion/exclusion criteria.
Overly narrow inclusion criteria can create longer recruitment times as the protocol may need to be amended. In a cross-case analysis of 3,400 clinical trials, more than 40% were delayed by four months due to protocol amendments.
Another problem biopharma companies experience is their inability to recruit sufficient participants to meet the sample size required. One study showed that one-third of publicly-funded clinical trials failed to meet initial recruitment goals. Particularly for cancer trials from 2005 to 2011, about 20% (48,000 participants) could not reach completion.
Clinical trials also constantly struggle to achieve diversity goals that represents real-world populations. For example, African Americans make up 5% of clinical trials but represent 12% of the US population. Likewise, Hispanics make up 1% of clinical trials but represent 16% of the US population.
To be prepared for decentralized trials, you must integrate real-world-data (RWD) with the appropriate data science techniques to help you match volunteers who adequately represent your target population.
According to Patrick Sturges, MS, CCRP, “With the emergence of RWD utilization in clinical research, achieving effective recruitment and retention is more plausible than at any other time in the field of clinical research. RWD facilitates a better understanding of the available patient population and improved protocol design.”
Trialbee is the global patient recruitment innovator, leveraging RWD and advanced data science techniques to achieve diversity and engagement goals.
Part of the patient profiling entails the ability to match patients based on robust clinical profiles that document age distribution, sex, race, diagnosis, medications, and procedures – including the ability to identify suitable patient populations down to a 3-digit zip code.
Harness Real-Time Tracking of Patient Data
Decentralized clinical trials benefit significantly from real-time tracking of patient data. Automated data collection is even more desirable. Project managers should have access to the most updated and accurate results.
Trialbee provides a single integrated patient-centered system that captures high-quality study data. Our real-time tracking provides granular analytics on a dashboard for project managers to stay updated on volunteers’ activities. Volunteers also stay connected due to engagement tools and user satisfaction.
Moving Towards Decentralized Trials
Your decentralized clinical trial will benefit significantly from access to advanced RWD-driven insights and automated data collection in a single integrated system.
If you are interested in learning more about how to incorporate advanced data into your clinical trials to reduce disruptions and delays, view our on-demand webinar: Minimize the Impact of Trial Disruptions. In this webinar, Lollo Eriksson, Chief Strategy Officer of Trialbee, and Magnus Ytterstad, VP of Analytics for Captario, discuss how to accelerate trial delivery through data-driven digital tools and solutions.