New Recruitment Service Helps Find Patients for Clinical Trials

Medicine does not advance unless people participate in research studies to learn more about health, disease and new treatments. However, only a low percentage of people ever do.

Many clinical trials fail to meet their recruitment goals, putting medical advances at risk and greatly increasing the cost of drug development. One of the issues is that potential participants may be unaware of the opportunity to enroll in clinical trials because physicians tell few patients about opportunities to participate in research.

“Recruitment is one of the most difficult aspects of any clinical study,” said Nariman Nasser, director of participant recruitment at UCSF's Clinical & Translational Science Institute (CTSI). “Eighty percent of clinical trials fail to meet their enrollment goals. The recruitment of research participants is critical to conducting clinical and translational research, and if we cannot recruit adequately, we simply cannot carry out successful clinical research.”

A study published in the November 2011 issue of Academic Medicine found that at Oregon Health & Science University (OHSU), a leading academic medical center, one-third of all studies terminated between 2005 and 2009 had zero or only one participant. Unsuccessful recruitment for these studies cost OHSU almost $1 million annually.

UCSF — with 5,269 clinical trials active in 2011 — is at the forefront of testing new treatments, but is not immune to the challenges of study enrollment.

UCSF Participant Recruitment Service

To foster clinical research and to help both patients and physician-scientists meet their health care and research goals, UCSF has established the Participant Recruitment Service (PRS).

“The Participant Recruitment Service is an added resource that is centralized,” said Nasser, who directs the PRS. “We can provide broader recruitment services more efficiently and effectively, including mailing services, and activities related to recruitment and the hiring of vendors — as well as resources that researchers wouldn’t necessarily be able to get their hands on. Economies of scale come into play, and we can save them money.”

Depending on the specific needs of a study, the PRS offers researchers at UCSF and its affiliated hospitals and clinics support to leverage various ways of recruiting study participants, Nasser said. These include referral networks, community outreach, traditional media advertising and digital communication, as well as detailed recruitment planning, evaluation and materials. 

UCSF Participant Registry

The PRS now has launched the UCSF Research Participant Registry. The aim of the registry is to allow those who want to volunteer for research studies to provide their self-reported information in one secure database that can be searched against criteria for any study being conducted at UCSF, so that those who sign up can be contacted about studies of interest. 

Now individuals who want to be contacted about participating in research studies can sign up for the UCSF registry online or by phone. After consenting to join the registry and providing contact information, they are asked to fill out a survey and health history. Hundreds of new potential study participants have signed up so far, including many UCSF students and staff members, according to Nasser. “Many have already been recruited and enrolled into specific studies,” she said.

“There are many kinds of clinical studies - not only controlled, randomized clinical trials. Participation in some is as easy as answering an online survey in 10 minutes; others may involve receiving an organ transplant and 10 years of follow-up.”

Before going live with the Pariticpant Recruitment Service, Nasser led recruitment for four studies to test it, and she and her colleagues then fine-tuned, based on feedback from researchers.

Among the first to test the service was Margaret Fang, MD, director of UCSF’s Anticoagulation Clinic and principal investigator for the COAG study (Clarification of Optimal Anticoagulation through Genetics). “As an investigator new to clinical trials, I have found that the most difficult part of conducting the trial is designing and implementing an effective recruitment plan,” Fang said.

"The service was incredibly helpful,” she added. “I did not know how to recruit patients during the brief interval between the time a physician determines the need for a specific drug and the time that the patient receives the first dose. The Participant Recruitment Service, however, outlined different recruitment strategies, calculated a recruitment budget and assisted with carrying out the recruitment plan.”