The success of clinical trials is contingent upon finding participants who meet certain criteria, ensuring that the resulting study data are meaningful and relevant to the target patient population. Clinical trial matching is the process of identifying and connecting potential participants with studies that align with their specific medical condition and characteristics. In precision oncology, where targeted therapies and biomarker-guided therapeutics are redefining standard of care, trial matching is increasing in both complexity and importance as study eligibility is often contingent upon strict molecular, genomic, and clinical profiles.
Today’s oncology research environment is also extremely competitive, and sponsors seeking to optimize study enrollment and retention need a proactive, multi-pronged approach to clinical trial matching and accrual that identifies and engages the key stakeholders who influence study participation. In this blog post, we discuss strategies for increasing clinical trial awareness among patients and healthcare providers (HCPs) so that they can opt into potentially relevant studies. We also explore the role of technology in optimizing the trial matching process.
Why strategic clinical trial matching is so important?
Effective clinical trial matching yields diverse benefits whose value is only heightened in precision oncology trials where therapies are targeted and patient populations may be limited:
- Increased patient access. Patients and physicians can more easily find appropriate clinical trials they might not otherwise have been aware of, giving them access to potentially beneficial treatments.
- Improved recruitment. Sponsors can find potentially eligible participants more efficiently, reducing recruitment delays and ensuring that required sample sizes are reached.
- Reduced screen failure. Ineligibility remains the most common cause of screen failure. Clinical trial matching facilitates pre-screening based on a study’s specific inclusion and exclusion criteria. Moreover, pre-screening performed for one trial may help identify patients for other active or future studies.
- Greater diversity. By broadening the visibility and reach of clinical trial information, matching platforms can help sponsors recruit a more diverse group of participants, leading to more generalizable and representative study results.
- Accelerated development. Faster recruitment means that trials can be conducted more quickly, accelerating the pace of development. This can be critical for specialty pharma and bootstrapped biotechs who are under pressure to reach milestones as quickly as possible.
Patients and caregivers: Ambassadors to clinical research
There are myriad approaches to increasing patient and caregiver awareness of—and desire to participate in—relevant clinical trials. Establishing relationships with patient advocacy groups and enlisting their help in spreading the word about clinical trial activity in their indication of interest has long been a mainstay of creating awareness and supporting recruitment, especially for rare oncology and other cancers with high unmet needs. As industry and regulatory agencies seek to integrate the patient experience into clinical trials, it is becoming increasingly common for sponsors to engage patients, caregivers, and advocacy groups in providing feedback on protocol feasibility, thus generating awareness and building ambassadorship in the early stages of clinical development.
The internet has empowered patients and caregivers to become more informed, more effective self-advocates. Through digital technology and social media, they can connect with others who have embarked on similar cancer journeys, allowing them to share and compare experiences and treatment options. To meet patients and caregivers where they are already searching and conversing, sponsors can create informational landing pages that allow patients to express their interest in—or even self-select and pre-screen for—a clinical trial that is a potential match for their tumor profile. These candidates can then be further qualified through additional online or phone screening programs.
The value of the HCP
Generally, HCPs are the link between patients and the studies for which those patients might be eligible. Therefore, HCP awareness of a particular clinical trial is crucial for encouraging participation and improving enrollment. Presenting at conferences and collaborating with medical associations that disseminate information to their members are well-established approaches for promoting study awareness. Webinars, continuing medical education events, and peer-to-peer communications are also useful for keeping HCPs up to date on the latest clinical trial opportunities that are relevant to their patients.
Sponsors can target and refine their clinical trial matching efforts by identifying investigators and sites that not only treat patients with the indication under investigation, but also screen for the biomarker of interest as part of their standard of care. At Premier Research, we leverage our extensive, global database and network to help sponsors identify and qualify those investigators and sites that are most likely to have access to eligible patients. These rich resources are extremely useful in efficiently identifying and connecting the right patients with the right trial in precision oncology.
The art of modernizing clinical trial matching
Advances in technology beyond the proliferation of the internet and social media are continually driving more efficient and more precise trial matching.
Clinical trial matching and recruitment technologies and services
Clinical trial matching platforms or services integrate and interrogate various data sources—including electronic health records (EHRs), genomic information, and eligibility criteria for ongoing and upcoming studies—to allow patients and HCPs to search for relevant clinical trials or to assist sponsors in identifying potential study participants. Generally, these types of software apply sophisticated algorithms and machine learning techniques, leading to better patient matching and more targeted recruitment efforts. They may also use natural language process technology to extract information from unstructured text such as clinic notes or clinical trial descriptions, or big data analytics to identify patterns and trends. Sponsors who opt to use clinical trial matching or recruitment software may supplement it with educational content, social media, paid search campaigns, and pre-screening.
In recent years, recruitment agencies have developed novel approaches to identifying and engaging with potentially eligible study participants. Some leverage behavioral data science and social algorithms to create therapeutic-specific and patient-centric content to introduce clinical trials to patients while they are researching their disease online. Others focus on rare cancers or specific oncology indications. Artificial intelligence (AI)-driven chatbots and virtual assistants are also being used to engage with potential study participants and to help determine trial eligibility.
Genomic profiling technologies
The advent of next generation sequencing (NGS) enabled the matching of targeted therapies to tumor molecular profiles in clinical trials. As this high throughput technology has become increasingly robust, accessible, and affordable, NGS panels are becoming more common in clinical practice to guide management or treatment selection.
Companies that perform genomic testing and profiling now have sizeable databases that can be tapped to match patients to trials based on genomic alterations, tumor type, age, and even proximity to the nearest enrolling site. Central, specialized, and smaller labs may offer similar services. While this trial matching approach does not connect sponsors directly to patients, it enables outreach to the ordering physicians to gauge their level of interest in specific clinical trials.
Choosing the right model for your study
Approximately 80% of all studies fail to meet their designated enrollment timelines.1 In oncology—where 80% of patients are unaware of their clinical trial options and less than 5% ever enroll in a clinical trial—enrollment may be further delayed.2 Moreover, as the inclusion and exclusion criteria for precision oncology studies increase in number and complexity, the process of recruiting, referring, screening, and enrolling patients has become even more challenging. To identify qualified participants more quickly and precisely, sponsors may need to use multiple channels—both offline and digital—to engage with patients, caregivers, and HCPs.
While advances in technology are helping to refine and streamline the matching and recruitment process, it is still important for sponsors to work with an experienced CRO partner who understands both their overall development strategy and the nuances of their ongoing or upcoming study. To learn more optimizing recruitment for your precision oncology study, contact us.
[1] Desai M. Recruitment and retention of participants in clinical studies: Critical issues and challenges. Perspect Clin Res. 2020;11(2):51-53.
[2] City of Hope. Are cancer clinical trials safe? Answer to common patient concerns. Available at: https://www.cancercenter.com/community/blog/2021/06/are-cancer-clinical-trials-safe