New Initiative to Aid Clinical Trial Recruitment
Volunteer participants are vital to the clinical research process, as everyone knows. Lack of enrollment is a leading reason for study delays or failure altogether.
To that end, the North Carolina Clinical and Translational Sciences (NC TraCS) Institute recently unveiled two efforts it has underway to help facilitate recruitment of participants in clinical research at UNC. At a luncheon hosted for them by NC TraCS recently, clinical study coordinators heard about a new online searchable database for potential volunteers to find out more about trials at UNC and to begin the enrollment process. Researchers from the UNC School of Journalism & Mass Communication also presented plans for an awareness campaign about clinical research.
Volunteer participants are vital to the clinical research process, as everyone knows. Lack of enrollment is a leading reason for study delays or failure altogether.
To that end, the North Carolina Clinical and Translational Sciences (NC TraCS) Institute recently unveiled two efforts it has underway to help facilitate recruitment of participants in clinical research at UNC. At a luncheon hosted for them by NC TraCS recently, clinical study coordinators heard about a new online searchable database for potential volunteers to find out more about trials at UNC and to begin the enrollment process. Researchers from the UNC School of Journalism & Mass Communication also presented plans for an awareness campaign about clinical research.
Finding Clinical Research at UNC
Located at http://researchstudies.unc.edu, the website allows volunteers to search for clinical studies by gender or age of research subject and area of medicine. Or, one can select “Healthy Volunteers.” After selecting any combination of search terms, users see a screen listing studies for which coordinators are actively recruiting and then have an opportunity to click through for more detailed information. The process of using the database is entirely anonymous. Users do not input any personal information. People who are interested in more information, or participating in any of the studies, can contact the individual study coordinator directly by telephone, which is listed at the bottom of each detailed study description. Only studies that have received Institutional Review Board (IRB) approval are posted.
At last count, coordinators had listed 92 clinical trials, and they are adding more daily. Though the list does include some cancer trials, the site also points volunteers to the UNC Lineberger Comprehensive Cancer Center Clinical Trials website, which has many more cancer studies listed. Also, they will see how to join ResearchMatch, a secure, national registry of potential research volunteers.
"This clinical research database serves as an excellent resource for patients who are in search of clinical trials, or for healthy individuals who would simply like to contribute to scientific discoveries,” said Amy Marzinsky, R.N., a clinical research coordinator in pediatric surgery who previously was a coordinator at UNC Lineberger. “It is very easy to navigate, and adheres to strict confidentially standards. That being said, it is also an outstanding recruitment tool for coordinators."
“Our goal is to help the public easily find, in one place, information about clinical studies taking place at UNC. All of this currently exists in many separate locations across campus,” explained Rosemary Simpson, chief operating officer of NC TraCS. “Development of this database is central to our mission to accelerate the pace of clinical research as part of the NIH Clinical and Translational Science Awards program.”
Raising Awareness about Clinical Research
Also at the luncheon, Jessica Willoughby, a doctoral student in the UNC School of Journalism & Mass Communication, presented a campaign she is working on with assistant professor Heidi Hennink-Kaminski, Ph.D., to raise awareness about clinical research and how participation benefits society and individuals. They have completed a situation analysis and are now conducting focus groups across North Carolina to learn more about the perceptions of the general public toward clinical research. Focus group findings will inform the development of two or three different campaign themes, which will be tested with North Carolinians and other stakeholder groups. A final campaign theme will be selected and refined, culminating in campaign materials for NC TraCS to use to educate people about the importance of participating in clinical research.
“Most communication about clinical research is related to recruitment for specific clinical trials rather than higher-level ‘reason why’ messaging that helps people understand that they can make a difference in real people’s lives,” said Willoughby. A few notable exceptions include the “Medical Heroes” campaign sponsored by the Center for Information & Study on Clinical Research Participation, and the 2004 NIH Public Trust Initiative. “At the end of the day, however, it’s important to realize that people typically move from awareness, education and interest as they approach a participation decision,” said Hennink-Kaminski. “Outreach with a ‘reason why’ approach in tandem with current recruitment calls-to-action may bring more people into the participant pool. And we’ve seen this combined effort work in other areas such as organ donation.”
Hennink-Kaminski and Willoughby have also found that while public support for medical and health research remains high, trust in clinical research has eroded due to some well-publicized controversies. So, while there is interest in participating as a function of potential volunteers’ sense of altruism, personal experiences, hope, and even the prospect of compensation or free medical care, barriers remain. These include logistical issues of time, transportation and child care, in addition to any level of mistrust, fear or simply lack of awareness they have about opportunities to participate.
Once Hennink-Kaminski and Willoughby have completed their research-based approach to materials development, the NC TraCS Communications Group will manage implementation and evaluation of the campaign.
