Pandemic highlights tech’s star power in trial recruitment

Recruiting patients for clinical trials is challenging and often the rate-limiting step in bringing a new drug to market, and recruitment delays are costly, resulting in lost potential revenue ranging from $600,000 to $8 million per day per drug.

COVID-19 only amplified the challenges of patient recruitment, ultimately forcing trial sponsors to rethink and improvise on their trial strategies, typically by leaning more heavily on digital solution providers to enable decentralized clinical trials. In decentralized trials, patients and clinical trial staff use technology to interact and share data remotely, thereby expanding the pool of potential trial participants by enabling patients anywhere to participate with few or no visits to a centralized trial site.

One of the keys to realizing the full potential of decentralized trials is digital patient recruitment technology that identifies and attracts the largest possible pools of candidates for clinical trials, taking maximum advantage of the fact that decentralized trials eliminate or reduce the constraints of geography and related factors on trial participation. We profile several companies that have developed innovative technology solutions for identifying, attracting, and retaining high-quality pools of patients for clinical trials.

Introduction

The drug R&D process is inefficient, complex, bureaucratic and, above all, expensive. According to the Tufts Center for the Study of Drug Development, it takes an average of $2.6 billion, including cost of failures, and 10-15 years to discover, develop and win approval for a new drug. Additionally, only one of every 10 drugs that starts trials ends up being approved by the FDA. Patient recruitment is often the rate-limiting step in the process.

Historically, recruitment has been largely dependent on physician referrals and patients’ ability to successfully navigate clinicaltrials.gov, a database of privately and publicly funded clinical studies. Challenges to recruiting patients include making patients aware of trial opportunities, overcoming patients’ fears about participating or mistrust of trials, and accommodating patients’ time and economic constraints. In normal times, about 50% of clinical trials need to extend their recruitment period, resulting in lost potential revenue ranging from $600,000 to $8 million per day. Additionally, 11% of trial sites fail to recruit any patients, and 37% under-recruit and fail to meet their enrollment targets.

COVID-19 only amplified these challenges. The industry’s shift to developing COVID-19 vaccines and treatments along with lockdown measures, restricted travel for patients, trial site closures, and redeployment of research personnel to treat COVID-19 patients forced many trial sponsors to stop initiating non-COVID trials and severely disrupted ongoing trials. In April 2020, when restrictions were most severe, a survey of 1,030 trial site personnel conducted by Medidata indicated about 70% were impacted in their ability to conduct ongoing trials and about 80% were impacted in their ability to start new trials. 

TABLE 1: Clinical trial initiations in 2020 compared to prior year pre-COVID baseline

Source: Trialtrove, Informa Pharma Intelligence.

As the pandemic continued, trial sponsors were forced to rethink and improvise on their trial strategies, typically by leaning more heavily on digital solution providers to enable decentralized clinical trials (DCTs). Essentially, decentralized trials are trials conducted either completely or partially outside traditional trial-site settings (academic medical centers) using digital tools that enable direct-to-patient support and remote monitoring. These digital tools include telemedicine, wearable devices and sensors, electronic clinical outcome assessments (eCOA), and electronic patient reported outcomes (ePRO). 

Before the pandemic, decentralized trials were generally viewed by the traditionally risk-averse pharma industry as a nice-to-have, not need-to-have, trial option. They were typically relegated for use in observational trials and low-level chronic disease trials such as for asthma and dermatology. But by mid-2020, decentralized trials surged as both new and suspended trials resumed patient recruitment amid the pandemic. Use of decentralized trials expanded to COVID-19 vaccines, immunology, cardiovascular conditions, oncology, central nervous system conditions, and non-COVID infectious diseases. In a November 2020 survey of clinical trial professionals conducted by Oracle Health Sciences, 76% of respondents said the pandemic had accelerated adoption of decentralized trial solutions, while 38% reported that more than half of their trials had already been decentralized. 

The primary benefit of decentralized trials is that they enhance trial participant diversity by expanding the pool of potential trial participants. Traditionally, the composition of participant pools in clinical trials has been a function of where investigators are located rather than where patients are located. Usually, this means patients are recruited from large metropolitan areas where investigators work, because getting to these locations can be difficult and costly for patients living in rural areas or distant cities. Since decentralized trial technology eliminates or reduces the need for participants to physically visit a trial site, distance is no longer a substantial barrier to participation. 

One of the keys to realizing the full potential of decentralized trials is digital patient recruitment technology that identifies and attracts the largest possible pools of candidates for clinical trials, taking maximum advantage of the fact that decentralized trials eliminate or reduce the constraints of geography and related factors on trial participation. We profile several innovative technology solutions for identifying, attracting and retaining high-quality pools of patients for clinical trials. 

It takes a village 

According to life science consultant Randall Hein, CEO of Heinsight, “COVID has shifted pharma’s approach to trial recruitment away from a one-and-done strategy toward one of continuous engagement.” Hein says “It’s no longer ‘let’s find patients for trials.’ Instead it’s, ‘let’s find trials for patients.’”

One notable example is CureClick, a patient-community-powered platform focused on increasing clinical trial awareness and accelerating patient recruitment by enabling trusted influential members of online communities to easily find and disseminate accurate, patient-friendly trial information across their social networks. Recently, the company announced a partnership with decentralized research platform provider THREAD, which focuses on increasing recruitment for decentralized clinical trials by leveraging CureClick’s network of more than 100,000 patient activists and advocates. CureClick CEO Fabio Gratton commented, “Disease doesn’t know geography, and trial recruitment shouldn’t  either.”

TABLE 2: Science 37’s decentralized trial platform

Source: Science 37.

Another notable example is Science 37, a decentralized trial platform provider that leverages an expansive network of telemedicine investigators, mobile nurses, remote coordinators, patient communities and connected devices to break down barriers to trial participation. Science 37 CEO David Coman noted, “The company’s DCT platform provides trial sponsors with the ability to recruit and enroll patient cohorts that are three times more diverse than a traditional site-based model.” The company recently announced a strategic partnership with Syneos Health (SYNH). The partnership will offer trial sponsors a unified and seamless platform that accelerates research by enabling workflow orchestration, evidence generation and data harmonization. 

Like CureClick, Be the Partner leverages patient communities to recruit patients. The company’s platform enables clinical trial participants and alumni to remain connected to research sponsors by receiving from them news and information about specific treatments and trials. Another notable vendor, Circuit Clinical, offers an innovative patient rating and review platform for clinical trials called TrialJourney.

CEO Irfan Khan describes TrialJourney as a sort of Yelp-meets-Healthgrades that patients can use to find actively enrolling clinical trials and nearby research centers, access peer-to-peer decision support, and share experiences in the form of ratings and reviews. According to Khan, “Post-COVID, not all trials will be decentralized, but all will have some decentralized components in which patient engagement and enrollment support will be key aspects.”  

Finding a needle in a data stack 

Another patient-centric approach to trial recruitment involves mining electronic medical records (EMRs), genetic data, biomarkers, and other types of digital data to identify patients who might be eligible for a clinical trial. Mining this data can be tedious and time-consuming work that requires a physician or nurse to read through unstructured narrative data in patient records and cross-reference a growing number of eligibility criteria for a trial. The average number of study protocol inclusion criteria has nearly doubled in the last decade, and according to the Tufts Center for the Study of Drug Development, the average number of distinct protocol procedures in Phase II and III trials has grown by 44% since 2009. 

With artificial-intelligence (AI) based digital solutions, like the solution used by Deep 6 AI, sponsors can more quickly and efficiently identify and enroll participants and make trials more accessible and convenient. Deep 6 AI’s software uses natural language processing to analyze structured data, such as ICD-10 codes, and unstructured clinical data, such as doctors’ notes, pathology reports, genomic data, discharge summaries and operating notes.

According to CEO Wout Brusselaers, “COVID has highlighted the need to connect trial stakeholders with a digital workflow. By recently partnering with AWS we can construct a federated system where we can have multiple academic medical centers, smaller trial sites, sponsors, and CROs all act and share workflows on a common data infrastructure while maintaining high levels of data privacy and security.” 

Two other notable vendors using similar patient-centric approaches are Elligo Health Research and Mendel. Elligo’s ResearchConnect platform mines EMRs and leverages the trusted patient-physician relationship to recruit patients as well as provide physicians with digital tools to conduct trials in their own practices. Via its recent partnership with and investment from Cerner (CERN), Elligo now has access to over 100 million patients and over 100 community-based healthcare practices. According to Elligo co-founder Chad Moore, Elligo’s collaboration with Cerner could be a game-changer for the company. 

Mendel’s AI-based software uses deep learning technology to sift through unstructured data in medical literature and data in patient health records to suggest evidence-based treatment options. It updates the results whenever a new matching trial or treatment emerges. The company has turned its attention toward mining unstructured data for real-world-evidence (RWE) trials.

TABLE 3: Mendel’s fax analytics solution

Source: Mendel.

Mendel CEO Karim Galil says the company was recently asked by a large pharma company to quickly build a global cancer registry with more than 10,000 patients, a task the pharma company had found challenging due to the lack of interoperability between patient EMRs and siloed data located in disparate locations. Mendel noticed that the one constant among these disparate data sets was the ubiquitous use of faxes. With that, the company’s M3 solution was born. The company recently partnered with J2 to integrate its M3 into J2’s cloud fax workflow to make every fax “analytics-ready.” 

Strength in numbers  

No single patient-centric approach is a magic bullet for recruiting patients. Ultimately, recruitment is a numbers game that typically combines a variety of solutions and strategies. One innovative vendor focused on enabling trial sponsors to tap multiple recruitment resources simultaneously is Informa via its Citeline Connect platform. 

Unlike traditional clinical trial recruitment models, Connect works as a collective, focusing on collaboration instead of competition, by empowering over 75 recruitment partners on the platform to refer patients to research sites simultaneously using a pay-for-performance model. 

With Connect, sponsors get better participant matches, can optimize recruitment spend, and gain another level of transparency. Recruitment partners increase their pipeline of sponsors and get paid quicker. According to VP of Patient Engagement Mike Wenger, “Our industry-first model flips the recruitment funnel, zeroing in on the most qualified patients.”

In October 2020, Moderna recruited more than 30,000 participants for the Phase III study of its COVID-19 vaccine, using Connect’s platform in the final enrollment period to ensure representation of communities that have historically been underrepresented in clinical research and are disproportionately impacted by COVID-19. The study included more than 11,000 participants from communities of color. Within a few days, Connect activated 24 recruitment partners across a variety of specializations and recruiting methodologies, and each was able instantly to begin referring patients to enrolling research sites simultaneously. 

Faster. Better. Cheaper. 

The combination of decentralized clinical trials with advanced technology for patient recruitment represents a powerful contribution toward the goal of improving human health throughout society. With all segments of the population better represented and patients better matched to trials, therapeutics quality improves. As remote technologies, AI, and similar tools reduce the friction in finding and attracting patients for trials, drug development speed increases and costs drop. All this points to a bright future for the technology innovators making it possible.