Survey Sheds Light on Current Trends & Opportunities in Site and Patient Recruitment
Learn about the current trends and future opportunities that promise to transform the clinical trial site and patient recruitment services landscape.
Site and patient recruitment vendors are vital in supporting clinical trial operations across all phases and therapeutic areas. Their services help engage a suitable participant pool, facilitate clinical trial participation, ensure that selected sites have the resources to support clinical trial activities and more.
At the beginning of 2023, the PPD™ clinical research business of Thermo Fisher Scientific surveyed 120 drug developers across the pharmaceutical, biopharmaceutical and biotechnology sectors (referred to collectively as “pharma”) to learn more about sponsors’ current needs for site and patient recruitment services. Respondents were in management-level or higher positions at companies ranging in size, all of which had outsourced 20% or more of their site and patient recruitment activities over the last two years. Through this survey, we aimed to increase awareness of current trends, unmet needs and areas with promise to transform the clinical trial recruitment services landscape.
Data from the survey has produced enlightening insights about the priorities of both large and small/mid-size pharma companies that can be used to guide business decisions. While survey participants from large and small/mid-size pharma companies agree that managing site burden is a top priority for vendors to address in the clinical trial space, they differ in their opinions on other trends. Their feedback on how site and recruitment vendors can best solve these issues aligns, however, and offers clear opportunities for improvement and expansion moving forward.
Therapeutic area expertise and track record of success surface as top-tier selection criteria
Participants from both large and small/mid-size pharma companies concur on their top criteria for vendor selection. “Therapeutic area experience” and “a proven track record of success” are listed as the two most important overall factors for choosing both site and patient recruitment services.
Companies are seeking vendors who can demonstrate expertise in the nuances of recruitment and trial operations unique to a specific therapeutic area, especially in those indications that require particularly complex trial support. A proven track record of success indicates that a vendor has both the expertise to target appropriate sites and patient populations and the resources to successfully meet recruitment and enrollment goals.
Patient diversity is a high priority for larger companies
Increasing racial and ethnic diversity in clinical trials has been a stated goal of the industry at large for the past several years. There is clearly work to be done: Despite accounting for almost 14% of the United States population, Black Americans make up only 8% of clinical trial patients. Similarly, though roughly 19% of Americans are Hispanic/Latino, this group makes up only 11% of trial participants. Better representation of minority groups in clinical trials drives more inclusive drug development, and contract research organizations (CROs) have a vital role to play in supporting efforts to reach these goals. Interestingly, the survey results showed that almost two-thirds of participants from larger pharma companies rate improving trial diversity as “extremely important” or “very important,” while only one-third of their counterparts at small/mid-size companies share these views.
Yet, respondents from companies across the spectrum hold similar views on how site and patient recruitment vendors can help solve the issue.
- Building relationships with patient advocacy groups is essential. Patient advocacy groups can create a valuable connection to potential research participants, especially for rare disease trials. Input from patient advocacy groups can also help sponsors design and conduct trials that better align with patients’ priorities and lived experiences.
- Patient assistance resources, such as travel reimbursement and patient concierge services, help make clinical trial participation accessible to a wider population of patients.
- Patient education programs and resources can help inform potential participants of the critical role they can play in clinical research.
- Conducting research in more countries is key, as global expansion of trials increases access to a broader patient base and facilitates inclusion of a more diverse population.
Vendors with services and practices dedicated to increasing patient access are a crucial component in increasing clinical trial diversity. By partnering with site and patient recruitment vendors addressing these key issues, pharma companies of every size can ensure their clinical trial operations are optimally supported to reach and engage a diverse pool of potential participants.
Site capacity and under resourcing are a top challenge for smaller pharma companies
Participants from small/mid-size companies are far more likely to report site capacity and under resourcing as a top concern to be addressed. Staffing challenges continue to be an issue for sites, limiting their capacity to adequately support new clinical trials. Time-consuming and cumbersome recruitment and enrollment procedures contribute to the considerable burden placed on site staff. When selecting a site and patient recruitment vendor, companies are likely to prioritize those offering technologies and resources that mitigate this burden.
Additional trends, challenges and opportunities for site & patient recruitment vendors
Other high-priority trends for site and patient recruitment vendors to address include:
- Managing site burden: This is a top concern shared by respondents from large and small/mid-size companies alike, especially as clinical trials become increasingly complex. Selecting a recruitment vendor that can support sites in reaching and retaining patients while managing staff burden is key to ensuring that trials run smoothly and within timelines.
- Decentralized clinical trials (DCTs): This remains a growing and evolving arm of the clinical research landscape. While DCTs open new doors in patient access, they require unique support from patient recruitment vendors to facilitate DCT operations. Companies pursuing DCTs are thus focused on vendors with experience and capabilities dedicated to DCT support, such as direct-to-patient delivery, robust eCOA and ePRO platforms, and in-home visits.
- Patient centricity of clinical trials and managing patient burden: Participants from larger companies are particularly interested in the patient-centricity trend, and those from small/mid-size companies join them in wanting to see providers address concerns about patient burden. Features aimed at making research more “patient-friendly,” such as travel compensation, accommodation of remote visits and home health services can translate to increased accessibility and patient retention. Patient recruitment vendors with offerings dedicated to reducing patient burden and facilitating participation can appeal to sponsors looking to improve in these areas.
Patient retention is not viewed as a significant issue in general
While patient retention recently has been cited as a concern for clinical trial sponsors, a small percentage of those surveyed cite patient retention as “very problematic,” with roughly half of each group rating patient retention as only “somewhat problematic” and nearly as many indicating it is “slightly” or “not at all” problematic. Though it may not impact a substantial proportion of clinical trials, when it does arise, patient retention is an urgent problem to address, as it can significantly derail trial timelines and budgets.
To address patient retention issues, sponsors identify patient assistance resources, home visits, patient education and virtual/telehealth visits as the most promising answers, aligning with the perceived solutions for increasing trial access to a broader patient population.
Moving forward with industry insights
Amid evolving challenges in clinical research, findings from this survey provide a valuable look into clinical trial sponsors’ priorities. Participants from both large and small/mid-size pharma companies report a desire for therapeutic area expertise and a track record of success when choosing site and patient recruitment vendors. Patient diversity and site capacity issues emerge as key challenges for recruitment vendors to address.
As the clinical research landscape continues to shift, service providers can reflect upon insights from sponsors to guide their offerings. By providing optimal service and support, site and patient recruitment service providers can do their part to best serve clinical trial sponsors and patients.