Recruiting volunteers to participate in clinical trials can be one of the most challenging aspects of clinical research. Studies show that only 10 percent of eligible persons participate in clinical trials in the United States, even though more than 70 percent who have participated are likely to do so again.
Recognizing that studies won't get off the ground if they don't meet accrual requirements, YCCI is investing considerable resources to help investigators with patient recruitment. The goal is to move away from an outdated and inadequate model—posting flyers in the community to find study volunteers—in favor of a more sophisticated approach to subject recruitment.
Using the Internet as a Recruitment Tool
According to the Boston-based Center for Information & Study on Clinical Research Participation, surveys show that even though 94 percent of the public recognizes that participation in clinical research is very important for advancing medical science, 74 percent say they have no real knowledge of the clinical research process. That's one reason why YCCI revamped the clinical trials website that was created two years ago. The website featured a searchable database that interfaced with clinicaltrials.gov; it allowed participants to search for trials based on disease area, gender, age range, keyword, or investigator. It also allowed volunteers to search for trials seeking healthy subjects—a feature that has already drawn many volunteers. Additional pages on the site answered questions about the nature and requirements of clinical trials and what volunteers should consider when participating in a study, as well as stories about discoveries that took place at Yale thanks to volunteer participation.
About 3,000 volunteers registered on the site, which filled an immediate need to create a central location for patients seeking clinical trials at Yale. YCCI, however, saw an opportunity to create a more patient-friendly site that would also be more productive for investigators. Working with YSM's Web Group, YCCI revamped the site, which went live on September 26.
The new site enables volunteers to create a profile that allows them not only to sign up for individual trials but also to keep track of the kinds of studies that interested them. This "shopping cart" functionality has several advantages:
- providing volunteers with greater control over their information
- reducing the number of duplicate records investigators receive
- potentially increasing the accuracy of the information on record
Volunteers are more easily able to compare trials and edit their interests and contact preferences, which will allow YCCI to develop such additional marketing materials as newsletters targeted to specific disease categories and contact mechanism to tell volunteers when a new trial in a particular category is available. The contact mechanism also highlights specific trials on a rotating basis, drawing the user's attention to studies that need volunteers. "We're trying to create a sense of community around our clinical research activities by letting volunteers know how much Yale has to offer and making it easy and convenient for them to get involved," said Tesheia Johnson, YCCI's chief operating officer.
The new website will be one component of a broader patient portal that will present information about health care services and events at Yale in one location. With David J. Leffell, MD, CEO of YMG and deputy dean for clinical affairs for YSM leading the development of the website, it will serve as the new front door for clinical trials at Yale. In addition to information about clinical research, features will include such healthy living initiatives as health screenings, health and wellness programs, and names of speakers available for community events. "Developing medical advances and providing health care are two sides of the same coin," said Leffell. "Reaching out to patients in this way benefits both our research initiatives and the patients we serve."
A Multi-Phased Marketing Campaign
Overhauling the clinical trials website is the first phase of a multi-phased marketing campaign to attract volunteers to clinical trials at Yale. YCCI has hired a local advertising firm to develop a multimedia umbrella marketing campaign as part of the second phase. The campaign includes a general brochure about clinical trials as well as materials developed for minority populations. It also includes a direct mail component with letters thanking subjects for participating in clinical trials and urging them to visit the newly designed website.
The second phase of the marketing campaign is currently in the planning stages and will use such social media as Facebook and Twitter to reach and maintain contact with volunteers. "The use of social networking for businesses and services is so widespread by now that we would be missing an unprecedented opportunity to reach people if we didn't get on board," said Johnson. "It offers Yale a chance to learn more about potential volunteers and for them to find out more about us."
YCCI Works to Make Advertising More Affordable and More Effective for Investigators
YCCI has negotiated reduced rates—up to almost 50 percent depending on the size of the ad—for study recruitment ads appearing in the New Haven Advocate. Working with local advertising firm Mason, Inc. YCCI has also developed ad templates that allow investigators to create with ease compelling ads that are in sync with the umbrella marketing campaign. We strongly urge investigators to take advantage of this opportunity to bolster Yale's presence in the local media, maximize research dollars, and increase study accrual. In fact, if we are able to plan next year's ad space requirements in advance, we can realize even greater savings.
Ads to recruit minorities feature leaders from the AME Zion Church and JUNTA. The texts discuss health disparities in minority groups, explain the importance of clinical research, and include a call to action to volunteer.
Partnerships to Reach Underrepresented Groups
Participation of minority groups in clinical research is especially low, which may be an important factor in contributing to disparities in health care delivery. Increasing and retaining minority participation in clinical research is critical in order to improve health outcomes in these populations. This is particularly true in New Haven, an economically and racially diverse community in which more than 60 percent of the population is either African American or Hispanic. YCCI recognizes that different approaches may be required to reach minority populations: is developing approaches specifically intended to recruit minorities and other populations underrepresented in clinical research.
YCCI has recently developed two new partnerships to assist in its minority outreach efforts: one with JUNTA, the oldest Latino advocacy group in the New Haven area; and a second partnership with leaders of the African Methodist Episcopal (AME) Zion Church. Representatives of these groups are serving as cultural ambassadors to Yale's research programs, working both within the community and with Yale faculty to develop new recruitment approaches. The program is being instituted at Yale as a result of an ARRA-funded collaboration with the Mayo Clinic, which has a similar program in place that has served as a model for YCCI.
JUNTA and AME Zion leaders are participating in intensive training in all aspects of clinical research theory and practice, including such topics as patient protections and rights, regulatory requirements and research in specific disease areas that the leaders have identified. This training will enable them to become research advocates in the community and educate members of their respective groups about the research process.
Involving these leaders on a deeper level and earlier in the process–at the stage of research design—will ensure that clinical studies incorporate the needs of the community and at the same time foster trust, thereby enhancing community participation throughout the research process. "I'm excited about the potential of this initiative to bring researchers together with the community in a meaningful way," said Margaret Grey, DrPH, RN, FAAN, dean of the Yale School of Nursing, who was recently appointed as YCCI's director of community-based research and engagement.
Input from research advocates will also be incorporated into the new clinical trials website, along with information aimed at such other underrepresented groups as women and children. The goal is to dispel misconceptions held by these groups that may prevent them from participating in clinical research. Besides facilitating the promotion of positive long-term relationships between New Haven's Hispanic and African American communities and Yale research staff, JUNTA and AME Zion Church leaders will serve as an expert resource, using knowledge of their communities to advise YCCI and Yale investigators on how best to engage their communities in clinical research. They will identify the needs within the community and participate in projects, community engagement activities and community events designed to promote participation in clinical trials.
JUNTA representatives are also providing translation services to investigators who need consent forms and other study documents translated into Spanish. The partnership with these two groups is an excellent example of the kind of innovative partnership YCCI seeks to develop to engage the surrounding community more fully in Yale's research efforts.
The use of a multimedia, multi-phased approach directed at different populations is expected to increase participation in clinical trials. YCCI encourages investigators to contact Kristin DeFrancesco at firstname.lastname@example.org or 203.785.3852 with any questions or to request assistance with study recruitment.