Recruitment is essential for generating data on drug efficacy, which is crucial for the approval of new medical treatments. Clinical trial success hinges on the ability to recruit a sufficient and appropriate number of participants. As Cara Brant, chief executive officer (CEO) of Clinical Trial Media puts it, “Trials are intended to generate data on how a drug works and you can’t generate that data if you don’t have participants in the study. This makes recruitment one of the linchpins of clinical research and drug development as a whole.”
However, the landscape of clinical trial recruitment is becoming increasingly competitive. With over 450,000 clinical trials in progress globally, according to Brant. The task of recruiting participants has never been more challenging. Traditional recruitment methods often fall short in this highly competitive environment, leading to significant delays. In fact, 80% of clinical trials are delayed due to difficulties in finding enough participants while 85% fail to recruit enough patients, a problem that has a ripple effect on the entire drug development process.
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Traditional methods: Referrals, media advertising, and community outreach
Traditionally, clinical trial recruitment relied heavily on referrals from healthcare providers, advertising through various media, and community outreach efforts. These conventional methods have been effective to some extent but face significant limitations in today’s competitive environment.
Historically, referrals from primary care physicians and specialists have been a primary source of trial participants. Physicians treating patients with conditions relevant to the trial would inform eligible patients about ongoing studies. According to the Center for Information and Study on Clinical Research Participation (CISCRP), while 64% of the public believes they should learn about clinical research from their primary care providers, only 0.2% are actually recruited this way.
Before the advent of digital marketing, trials were advertised through traditional media channels such as newspapers, radio, and television. These methods aimed to raise awareness about the trials among a broad audience but often lacked the precision needed to target specific patient populations effectively.
Engaging with local communities and non-profit organizations has also been a conventional approach. These organizations often have established trust within specific patient populations and can help bridge the gap between researchers and potential participants. Non-profit organizations with dedicated communities for certain conditions can serve as trusted connection points for pairing qualified members with relevant trials.
Patient advocacy organizations and support groups often have the clearest view into the unmet needs of a patient community and can share insights that are often missed or undocumented in current literature, according to Dan Drozd, chief medical officer at PicnicHealth.
“When these unmet needs and the lived experiences of patients and caregivers are understood, the patient voice can help build a better study design, as well as recruitment plan, messaging, and materials. Patient advocacy is especially beneficial in finding a greater concentration of patients with high unmet needs in rare or ultra-rare indications. For patients considering participating in a trial, patient advocacy groups provide a trustworthy platform to assess the credibility of a sponsor or trial.”
Brant explained recruitment firms can partner with such groups to provide more information on the latest available trials so members know how and when to participate in the process. “A lack of information can be the greatest enemy when it comes to fully enrolling in a trial. Patient advocacy groups and nonprofit organizations can be critical to making sure the necessary people are educated.”
According to Matt Teuteberg, CEO of Splash Clinical, while these methods are still used to some extent the return on investment isn’t the best when compared to emerging tactics. Brant also notes, “These methods are very difficult to scale, so the industry has largely moved to digital marketing and precision advertising methods.”
Common obstacles: Patient eligibility, retention, and diversity issues
Brant identifies three main challenges to clinical trial recruitment. “1: necessary trial criteria that disqualify some potential participants, 2: a lack of awareness of the trials currently taking place, and 3: trial sites being stretched thin due to high demand for their work.”
The specific inclusion and exclusion criteria required for clinical trials can significantly limit the pool of eligible participants. This is particularly challenging for trials targeting rare diseases or specific demographic groups. As trials become more complex, the criteria often become more restrictive, making it harder to find suitable participants. “Without necessarily modifying the criteria of inclusion as it would not serve the purpose of the trial, we have to make sure they are easy to understand and patient-friendly.”
Many potential participants are unaware of clinical trials or do not understand their potential benefits. This lack of awareness is a major barrier to recruitment. Traditional recruitment methods such as referrals from healthcare providers and media advertising have limited reach, often failing to inform a broad audience about available trials. “Beyond the awareness of clinical trials themselves, a lot of potential candidates might not know about all the safety measures and rights they have as a patient, I wasn’t aware before I went into the industry ten years ago,” said Teuteberg.
Clinical trial sites are often stretched thin due to high demand and limited resources. This can lead to delays in patient enrollment and retention efforts. Sites may struggle to manage multiple trials simultaneously, each with its own set of requirements and logistical challenges. “Study sites are globally extremely busy, still recovering from Covid. We are constantly looking at ways to ease the burden of the site taking on a new patient and sponsors are also very aware of this issue and trying to ease the sites’ operations. The objective is to inform as much as possible before the enrollment to make the transition to the trial site as smooth as possible,” said Teuteberg.
Diversity and patient engagement, a condition to clinical trial success
Another challenge that intervenes after recruitment but is still worth mentioning is patient engagement. Patient engagement and retention are critical yet challenging aspects of clinical trial management. High dropout rates and lack of sustained participation can jeopardize the success of trials. Overall dropout rates soar up to 30% in clinical studies, which significantly impacts the integrity and completion of trials.
Many potential participants are deterred by fears of side effects or invasive study procedures. Providing clear, accessible information and reassurance through the consent process can help mitigate these concerns. Non-compliance can result from a lack of understanding or the perceived burden of participation. Last but not least, participants often face logistical challenges, such as travel to trial sites, which can be a significant deterrent.
Drozd believes that patient engagement can be improved through active, meaningful, and collaborative interactions that can make patients important advisors on study objectives, co-creating relevant educational and outreach materials as well as providing feedback to improve study processes. “Patient engagement shouldn’t end when the study does, but continue as a way to share research learnings with participants and the community so they can see and understand the value of their contributions.”
Ensuring diversity and equity in clinical trials is also crucial for developing treatments that are effective across different demographic groups. Diverse participation in trials helps researchers understand how drugs affect various populations, ensuring that medical treatments are safe and effective for everyone. The U.S. Food and Drug Administration (FDA) has reinforced the importance of diversity in clinical trials through initiatives like the DEPICT Act and new guidelines requiring diversity action plans for all phase 3 clinical trials.
“As the FDA noted, people from racial and ethnic minorities and other diverse groups are underrepresented in clinical research. The lack of diversity happens even in diseases that are more prevalent in these minority groups. The generalizability of a treatment’s benefit and safety is directly dependent on who participates in the trial. Treatment response, duration, and other factors may differ in various patient subgroups across biomarkers and age, for example,” confirmed Drozd.
“If we want medicine to work in everyone, we need to test it in everyone,” as Brant summarized it.
Modern clinical trial recruitment strategies
Radio, television, and newspapers seem a bit far in advertising strategies. New approaches have allowed for more precision in clinical recruitment strategies. While traditional methods are still important in clinical trial recruitment, direct outreach, digital marketing, and decentralized and virtual trials have reshuffled the cards.
Direct outreach and follow-up
Direct outreach and follow-up are crucial components of a successful clinical trial recruitment strategy. Engaging potential participants through personalized communication helps ensure their commitment and reduces drop-out rates. Automated platforms can significantly streamline this process by sending personalized messages to gauge interest and follow up with potential participants. This approach not only maintains a personal touch but also efficiently manages large pools of potential participants.
“One tactic that we have found particularly helpful in keeping participants retained throughout the trial process is finding methods to meet the flexibility needs of each participant,” said Brant. This could include simple gestures like creating activities for children of trial participants or more sophisticated support systems through trained nursing staff.
Digital marketing and social media
Digital marketing has transformed clinical trial recruitment by enabling precise targeting of potential participants based on geographic location and other relevant data. Social media platforms, online advertising, and digital campaigns allow researchers to reach diverse and specific populations effectively. This method is significantly more cost-effective than traditional media approaches and allows for more engaging and continuous interaction with potential participants.
According to Teuteberg, the clinical trial is no different than other industries when it comes to advertising: “If you look at other industries, let’s say the computer industry, companies like Dell use to rely a lot on traditional media but now they’re probably 80% to 90% digital, so the trial industry followed. It is just a better way to reach a more precise audience broadly.”
“Digital media has opened up a lot of possibilities for reaching out to people that we would have never had access to otherwise. Even in the case of older populations, for instance, we’re able to identify the online spaces where they gravitate and meet them where they are. Our industry has recently done a lot of work to open the door to healthcare for everybody, no matter their background. Digital media has played a large part in supporting that goal.” said Brant.
By leveraging digital tools, researchers can conduct highly targeted campaigns that resonate with the specific needs and characteristics of the patient population.
Drozd also notes how data captured through interactions with patients on a company’s own digital channels has also altered recruitment and how social media have unlocked new interaction for potential patients: “These first-party data are allowing companies to optimize their awareness campaigns, find the right trial participants, and use more nuanced advertising methods while staying compliant with changing privacy regulations. And with social media, patients can connect with other patients and learn from their experiences, and get encouragement from their community to participate before enrolling in a trial.”
Decentralized and virtual trials
Decentralized and virtual clinical trials are a revolutionary approach to reducing participation barriers. These trials allow participants to complete some trial activities locally or virtually, significantly increasing accessibility and convenience. This model became particularly prominent during the COVID-19 pandemic and has continued to grow in popularity due to its flexibility and patient-centered approach.
“Decentralized trials minimize geographic barriers and mobility limitations. Virtual trials meet patients where they are,” said Drozd.
“Decentralized trials enable patients to participate in some trial activity at locations within their geographic regions, rather than having all trial activity take place at a singular location. For instance, intermittent check-in lab work might take place close to their homes while only formal visits take place at the larger trial sites. Virtual clinical trials have some visits conducted via online portals so that instead of funneling all trial participants to a physical site location, patients can participate in some aspects from their own homes. These models aren’t just a big step toward democratization; they can make all of the difference when it comes to getting more people involved in trials,” explained Brant.
According to Teuteberg, while it is evident that decentralized and virtual trials represent the future of the industry, it has to be done the right way as these options also come with challenges.
“Our main focus at Splash is on patient engagement and ensuring the patient does not fall into the cracks leading them to drop out of the study. What can happen when being enrolled in a virtual trial is to feel less of an engagement, so it’s important to provide the understanding to patients that they still are part of the trial and they need to maintain consistency. I believe this factor to be the flip side of these options but we can mitigate carefully informing patients from the beginning and leveraging telemedicine technologies that will keep getting better.”
Leveraging technology in clinical trial recruitment
COVID has played a crucial role in the democratization of communication technologies. Telemedicine is becoming more and more standard and artificial intelligence (AI) is making considerable progress.
AI and data analytics: Optimizing the recruitment process
AI and data analytics have revolutionized clinical trial recruitment by enhancing efficiency and accuracy. AI-powered platforms can pre-screen potential participants, rapidly analyzing vast datasets to identify suitable candidates based on specific eligibility criteria. This technology not only speeds up the recruitment process but also improves the quality of participant selection.
AI-driven predictive analytics can forecast patient behaviors, treatment responses, and potential risks, allowing researchers to tailor their recruitment strategies dynamically. For instance, predictive models can help identify subpopulations most likely to meet the stringent criteria of clinical trials, thereby streamlining the identification and enrollment process.
“By utilizing AI, we can target specific patient populations more accurately and efficiently, reducing the time and resources needed for recruitment,” said Brant. AI tools like chatbots and virtual assistants further enhance engagement by providing instant information and pre-screening capabilities, fostering a stronger connection with potential participants.
Wearable devices and telemedicine: Enhancing remote data collection and patient monitoring
Wearable devices and telemedicine have significantly improved the management of clinical trials by enabling remote data collection and patient monitoring. These technologies allow participants to conduct site visits from home, reducing the need for travel and minimizing disruption to their daily lives. This increases accessibility and enhances participant retention.
Wearable devices can continuously monitor health metrics, providing real-time data that is crucial for assessing treatment efficacy and patient safety. Telemedicine facilitates virtual consultations, ensuring that participants remain engaged and compliant with study protocols despite geographical barriers.
The integration of these technologies into clinical trials has proven particularly valuable during the COVID-19 pandemic, as decentralized trial models have become more prevalent. This hybrid approach combines the benefits of home-based care with the structured environment of traditional clinical sites, improving patient experience and retention.
Integrated digital platforms: Streamlining communication and data management
Integrated digital platforms ensure seamless communication between participants, researchers, and trial sites, facilitating the efficient flow of information and enhancing overall trial management.
Advanced data management solutions provide centralized dashboards for tracking study progress, real-time notifications for keeping participants informed, and secure document management for regulatory compliance. These tools help streamline administrative tasks, allowing research teams to focus more on critical aspects of trial management.
Cara Brant highlights the importance of such platforms: “Our digital platforms integrate all aspects of the trial process, from recruitment to data analysis, ensuring that trials are conducted smoothly and efficiently.”
Future trends in clinical trial recruitment: a more patient centric-approach
Drozd sees the increasing complexity of clinical trials as a risk for the industry. “Moving ahead, alternatives to the traditional site model like virtual trials, addressing diversity with specific action plans in protocols, including the patient voice in trial design, reducing site burden, and enabling more patient-centric approaches to research will be critical.”
The future of clinical trial recruitment is being shaped by the integration of hybrid models that combine traditional methods with modern digital tools. These hybrid models leverage the strengths of both in-person and virtual trial components, offering a flexible and participant-centric approach. Decentralized clinical trials gained prominence during the COVID-19 pandemic, and their popularity continues as they enable broader participant reach and increased convenience.
“While digital tools and AI enhance recruitment efficiency, maintaining a human touch is crucial for participant engagement and retention,” said Brant. This approach helps in addressing the logistical and emotional needs of participants, thereby improving their overall experience and reducing dropout rates.
Teuteberg explained these new approaches, decentralized and virtual clinical trials, must be applied thinking about the patient first. “From an engagement and retention standpoint, it is really important to put the patient first, meaning understanding their health literacy, the disease’s epidemiology, and the patient’s treatment journey and integrate this insight from trial design to recruitment.” Going forward, the three specialists agree that a patient-centric approach must be maintained.
Teuteberg thinks the regulators are faced with a significant challenge with how fast the technologies are advancing. “Technologies always advance faster than regulation. Companies like Splash, working in clinical trial recruitment, have to be very thoughtful of the tools regarding integrity and ethics. We have to be aware of what regulators will be looking for and anticipate that.” Indeed, AI touching personal data is a sensitive regulatory topic, especially when it comes to medical data.
As the clinical trial landscape becomes increasingly global, expanding participant pools beyond the United States is essential for diversifying and enlarging recruitment efforts. This is now possible thanks to decentralized and virtual trials and all the tools surrounding these strategies.
“There’s a global push for more recruitment outside of the United States. With how competitive the environment is in America for participants, getting a more substantial number of participants from outside will be essential in keeping recruitment goals met,” said Brant.