Identifying, recruiting, and enrolling patients has long been one of the hardest challenges to overcome in clinical trials. The most commonly reported factors impacting the recruitment and enrollment rates of patients in clinical trials include:
- Stringent eligibility criteria
- Lack of awareness about clinical trials
- Fear and mistrust among the general population
- HCP reluctance to refer patients
- Lack of accessibility and logistical barriers to participation
- Burden and inconvenience for patients
The pandemic added another layer of complexity while simultaneously motivating clinical research leaders to expand and accelerate the development of strategies and solutions to the problem. Digital technologies and real-world data (RWD) emerged as approaches that quickly gained adoption as sponsors and investigative sites raced to counteract the potential deceleration of clinical research triggered by the COVID-19-related limitations on personal interactions and site visitations.
Many of the emerging solutions are already reducing the burden on patients and logistical barriers to participation in clinical trials, thus improving the accessibility of clinical trials to diverse populations of patients. But more can be done to enhance methods of finding and recruiting the right patients through raising awareness among the general population and healthcare professionals (HCPs), building trust in patient and HCP communities, and leveraging RWD to match patients to eligibility criteria. There needs to be more than a single strategy for clinical trial recruitment.
Empowering the right patients and HCPs with the right information at the right time
According to a study published in 2017 by the Center for Information and Study on Clinical Research Participation (CISCRP), 84% of patients would consider participating in clinical trials if their physician recommended that they do so. Surveys conducted by the Tufts Center for the Study of Drug Development (CSDD) in 2015-2016 suggested that 91% of physicians and 72% of nurses felt “somewhat” or “very comfortable” discussing clinical trial opportunities with their patients. And yet less than 0.2% of patients seen annually are referred to clinical trials by their physicians.
How do we bridge the gap between the patients’ interest in participating in clinical research, HCPs’ readiness to discuss clinical trial opportunities with patients, and the disappointing data on patient referral, recruitment, and enrollment rates? The solution lies in the timely delivery of relevant information to the appropriate patients and HCPs.
Some sponsor organizations emphasize the importance of using RWD to identify patients and HCPs yet fail to fully harness the recruitment potential by delivering the right message at the right moment to the right audiences. Conversely, other organizations have capitalized on digital marketing strategies but have struggled to engage the right patients and HCPs to prompt action sufficiently. By combining the power of RWD with the power of delivering relevant information to the right audiences at the right time, organizations stand to improve recruitment and enrollment rates and increase the probability of their clinical trials’ success. Let’s take a look.
Who are the right patients and HCPs, and how do you find them?
A 360-degree strategy for patient identification includes two elements: RWD and digital IQ. Each strategy alone may leave an untapped opportunity to reach the right patients. Together, these approaches increase the probability of recruiting and enrolling eligible patients faster.
Real-World Data (RWD)
The right patients will most likely match a clinical study’s eligibility criteria. The more granular and stringent the criteria, the harder it is to find the right patients. A patient may, for example, have a disease matching the inclusion criteria. Still, their genetic makeup, comorbidities, or concomitant medications may all be reasons to exclude them from a clinical trial.
Sponsors may consider optimizing the eligibility criteria, especially for phase III clinical trials, which typically require large numbers of patients to enroll. Real-world evidence (RWE) platforms such as Dexter can help define the right patient cohorts, while artificial intelligence (AI) tools, such as those built by Topazium, can help stratify patient populations based on early phases of clinical research to define an optimal set of inclusion/exclusion criteria for phase III.
Once eligibility criteria are well defined, RWD, such as electronic health records (EHR), claims data, prescription data, and more, can help find patients who match them. HCPs can use EHRs directly to identify the best candidates for clinical trials among their patients. Technology providers like Epic are undertaking efforts to make that matchmaking possible and accessible from within the EHR systems.
Data privacy regulations prevent many entities from accessing and using protected health information (PHI), such as EHRs. The US Health Insurance Portability and Accountability Act (HIPAA) allows only covered entities (HCPs, health plans, and healthcare clearinghouses) to mine patient data from EHRs to screen or recruit research subjects. That leaves sponsors to rely on healthcare systems and HCPs to match patients to eligibility criteria. Sponsors may be allowed to leverage RWD when such data is de-identified (stripped of certain identifying elements to protect an individual’s privacy and confidentiality). In those cases, RWD enables sponsors to identify healthcare systems or HCPs who have under their care the populations of patients who match study eligibility criteria.
Even when equipped with knowing where the right patient populations can be found, sponsors struggle to reach those patients as time and infrastructure constraints may prevent HCPs from effectively referring patients. It may be a tall order to ask HCPs to add another task to their already overblown schedules and to keep track of their patient recruitment progress. That’s where digital technologies, such as Medocity’s REACH platform, can make a difference by streamlining workflows from identification of qualifying patient populations and their HCPs through empowering HCPs to find and refer qualifying patients, all the way to equipping sponsors with actionable data about the progress of recruitment and enrollment.
Digital Observational Research (Digital IQ)
While RWD constitutes the most direct way to identify patients, protecting patient data privacy makes this direct route available only to HCPs. By complementing de-identified RWD strategies with digital IQ, sponsors can maximize the reach of their clinical trial recruitment efforts.
Digitalis reports that 77% of people use search engines to start their patient journey. And, according to a study published in 2015 by Journal of Medical Internet Research (JMIR), 90% of older adults used social media to seek and share health information. Social media can be used for ‘hard to reach’ groups that cannot be easily accessed through traditional methods. These include low-income populations, adolescents and young adults. Embedding a recruitment strategy in the digital lives of patients holds significant potential to lower cost and increase speed of recruitment. For example, trial recruitment for a gout study saved nine months on the enrollment timeline by using patients’ digital footprint for targeting. Also, a study published in the European Heart Journal documented the relative efficiency of social media in recruiting patients for a clinical trial for hypertension.
Digital IQ is observational research focusing on understanding people’s digital journeys and behaviors, including patients, caregivers, and HCPs. It allows us to map digital behaviors within a therapeutic area to understand barriers, opinions, and beliefs related to treatment and clinical trials. It also identifies the digital whereabouts and influences of relevant patients, caregivers, and/or HCPs.
Typical data sources leveraged in digital IQ include search data, social media, web analytics, consented zero-party data, etc. Insights derived from analyzing such data enable the creation of digital personas, or digital lookalikes, of the audiences to be reached. They also help define the channels through which to reach those audiences.
An exciting opportunity lies in adding a geographic overlay – derived from identifying healthcare systems based on the analysis of RWD, where potentially qualifying patients can be found – to the digital personas, journeys, and channels through which they consume content. This enables a greater precision with which to launch digital outreach to reach the right patients, their caregivers, or HCPs.
What is the right information, and how do you deliver it?
Lack of awareness, fear, and mistrust are among the factors that can prevent successful patient recruitment efforts. The right information is, therefore, the information that helps raise awareness and dispel fear. It is also the information about recruiting clinical trials relevant to a given audience at any given time.
For patients and caregivers, the right information can involve information about the disease, its symptoms, treatment options, and prognosis, and information about clinical trials – what they are, how they are conducted, and what trials related to the disease of interest are currently recruiting. A thoughtful explanation or clinical research, delivered in accessible language, can help reduce mistrust and fear and raise awareness.
HCPs are interested in knowing what trials are recruiting in therapeutic areas relevant to them and what eligibility criteria patients must meet to be enrolled in those trials. They may also want to know the details of what participation in a given clinical trial would mean for their patients to assess the burden they would be imposing on their patients by referring them.
All such information can be delivered through channels identified through digital IQ as the channels where patients, caregivers, or HCPs corresponding to digital personas are most likely to be found and consume content. The channels vary for each recruitment effort and can include:
For patients and caregivers: social media, websites of patient advocacy groups, patient fora, patient portals, educational websites dedicated to different diseases
- For HCPs: social media, professional medical associations websites, congresses/events, journals, channels used by key opinion leaders (KOLs)
Additionally, educational content and enrollment information can be shared directly with HCPs who are identified through RWD as those who have under their care patients potentially qualifying for clinical studies. HCPs with knowledge disseminated through digital outreach may be more likely to respond positively to referral requests.
The timing of digital outreach matters. To drive an overall understanding of clinical research or a disease, shape attitudes, and dispel fears, organizations should consider conducting digital IQ and launching awareness campaigns long before their clinical trial recruitment efforts begin. This will increase the probability that at the time of recruitment, the messages inviting patients to enroll or HCPs to refer patients will land with educated audiences equipped with the right knowledge to make informed decisions.
There needs to be more than a single strategy for clinical trial recruitment. That’s why at Globant, we combine our expertise in digital IQ and digital outreach with the capabilities of our partners, such as Medocity, Dexter, and Topazium, to help sponsors develop tailored 360 strategies to accelerate their clinical trial recruitment and enrollment efforts. Taking a long-term view, we recommend roadmaps that begin with a thorough understanding of audiences and their whereabouts, raising awareness about clinical trials in general, and preparing patients, caregivers, and HCPs for more specific outreach presenting specific clinical trial opportunities.
Find out more
Join us on Wednesday, October 11 at 11 am EDT for a 1-hour webinar with a cross-functional team of experts who will discuss:
- Digital observational research and digital outreach
- Matching patients to eligibility criteria using real-world data (RWD)
- Streamlining patient recruitment and enrollment with digital platforms
- Empowering stakeholders with a connected hub that streamlines the enrollment process