Studies Nationwide Struggle to Find People to Meet Enrollment Goals
Obstetrician gynecologist Vanessa Jacoby, MD, MAS, is dedicated to recruiting a diverse mix of participants in her clinical studies, but despite casting a wide net one of the biggest challenges in her trials remains finding enough people to include.
“Like so many other researchers, I have struggled repeatedly to meet my enrollment targets,” she said.
An estimated 80 percent of U.S. studies do not meet enrollment goals. This under-enrollment in a study can lead to scientific challenges, ethical concerns, financial difficulties and lack of diversity in trial populations.
The bottom line is that scientists can’t complete the scientific aims of their studies without adequate enrollment.
“Not meeting enrollment targets is a huge impediment to the advancement of science in every field,” said Jacoby, who recently became the director of the Participant Recruitment Program at the Clinical & Translational Science Institute (CTSI) at UCSF.
To help address the issue, UCSF has launched a tool that could make it easier for researchers and willing study participants to find each other.
Wide-Ranging Impacts from Lack of Participants
When a clinical trial fails to enroll enough applicants, the effects can be numerous. One large issue is that under-enrollment causes difficulties in securing funding or collaborators for future trials.
Another sometimes forgotten element, Jacoby said, is the ethical aspect. When researchers enroll a participant, they are promising they will conduct the study and accomplish its goals, which is impossible without enough subjects.
The universal problem of under-enrollment in clinical studies is magnified in women and minorities, which is quite detrimental to science because the results of those studies may not be applicable to the omitted patient populations.
UCSF’s New Recruitment Tool
Knowing the challenges of clinical study recruitment, Jacoby is excited about the launch of UCSF Clinical Trials, a trial-finding tool that could make it easier for her and other researchers to meet recruitment goals by helping people find and connect to clinical studies.
“UCSF Clinical Trials is really exciting because it connects two groups of people that really need to be connected,” said UCSF Associate Vice Chancellor of Clinical and Translational Research Jennifer Grandis, MD, who directs CTSI. “There has not been a mechanism to do this at UCSF, or anywhere really.”
Currently the government website www.clinicaltrials.gov contains information about thousands of studies using human participants, but the problem with that site, Grandis said, is that it is difficult to navigate for patients and researchers alike, it includes trials that may be located far away, and it often doesn’t include contact information for someone interested in joining in a trial.
“UCSF Clinical Trials basically takes all the UCSF-specific information from that government database, expands upon it and makes it much more user-friendly. Also, we give the interested public a way to reach out to study teams,” said Brian Turner, MBA, product director with the Research Technologies program of CTSI and lead on the of UCSF Clinical Trials project.
Easy to Search and Understand
The recently launched website aims to reduce the impact of under-enrollment on hundreds of studies at UCSF. As of Dec. 1, there were 1,330 trials in progress on the UCSF Clinical Trials site. Of these, 666 are open and recruiting participants, including 190 open to pediatric patients under 18 and 82 open to healthy volunteers.
UCSF Clinical Trials, which was built from the ground up, is aimed at giving the public a way to interact with UCSF. An often-unrecognized aspect to presenting clinical trials to the public, said Grandis, is a very straightforward and accessible explanation of the study.
“The mistake we make all the time is that we use scientific language to describe studies that does not engage or connect with our patients,” she said. “We hear all the time that consent forms and study explanations need to be more accessible both in content and style. We worked hard to make sure UCSF Clinical Trials is a user-friendly experience to support engagement with our diverse community.”
Beyond simply a search tool for finding clinical trials, the website includes information on it for researchers, patients and the public about how clinical trials work, what they are and what is involved in participating.
Notably, the site includes a button to click for users to indicate that they are interested in a particular study or to print it out to discuss with their primary care physician.
“This website empowers the users,” Turner said. “It gives them some things they can do, not just information to read.”
Looking to the Future
The launch of UCSF Clinical Trials likely won’t solve all of the recruitment problems for trials. In looking ahead, the creators already have plans for expansion. They have received funding to include trials from all five of the UC health campuses and have been brainstorming ideas about a future where the system reaches out to potentially interested individuals and communities.
Part of our challenge in engaging participants is highlighting the value of clinical research.
Director of the Participant Recruitment Program at CTSI
Jacoby noted that the trial finder is one helpful piece in improving the problem of under enrollment, which requires a multipronged approach.
UCSF also has other tools for research teams to help with recruitment. CTSI has developed a process to identify eligible study participants using the electronic health records and send these patients letters that invite them to participate in the study. CTSI also offers researchers an hour of free consultation services to help develop a recruitment plan and budget, create recruitment materials and utilize social media strategies.
A large priority with UCSF Clinical Trials, and all other methods for communicating with possible trial participants, is opening a dialogue about how important people are to the process of clinical research.
“Part of our challenge in engaging participants is highlighting the value of clinical research,” she said. “Most of all, we want to convey how grateful we are for people to participate in trials and how their participation is what is driving science forward.”