Trial Library

Aim

Researchers at UCSF need to recruit a diverse array of people to participate in their clinical trials. Having a wide range of participants strengthens the studies, making the results more applicable to a general population.

Diverse recruitment also helps correct a historic injustice, in which under-represented minorities were often excluded from clinical trials. This practice meant the results of the trials may not have been applicable to the minority populations.

Additionally, many people suffering from disease want to participate in the trials in the hopes of getting a treatment or advancing the science, but this opportunity was also historically denied to under-represented minorities.

According to studies, Black and Hispanic patients account for less than 5 percent of clinical trial participants, despite comprising 12 percent and 16 percent of the US population, respectively.

In certain diseases like prostate cancer, clinical trial disparities based on race and ethnicity are pronounced. For instance, Black men have an increased risk of developing and dying from prostate cancer compared to White men, yet Black men are grossly underrepresented in therapeutic clinical trials.

In addition to diversity, clinical trials just need to recruit patients in general. “More than 30 percent of clinical trial sites fail to recruit even a single participant, 50 percent of clinical trials fail to reach their enrollment goal, and fewer than 20 percent of clinical trials are completed on time,” according to a paper by Hala Borno, MD, and others from UCSF published in the journal Pilot and Feasibility Studies in 2019.

“The current strategies for clinical trial recruitment leave much room for improvement,” the paper said.

Partners

Hala Borno, MD, is a UCSF oncologist who cares for patients who have cancers along the urinary tract, including kidney, bladder, testicular and prostate cancer. According to her web site, Borno’s research focuses on understanding the causes of inequalities in cancer prevention, treatment, outcomes and clinical research participation. She is also interested in developing new ways to address the causes of these inequalities.

Borno saw the potential to use technology to cast a wider net in drawing a large and diverse group to participate in the studies. “The increasing prevalence of online connectivity in the USA and use of the Internet as a resource for medical information provides an opportunity for digital recruitment strategies in cancer clinical trials,” according to Borno’s paper from Pilot and Feasibility Studies.

The paper was titled: “A Step Towards Equitable Clinical Trial Recruitment: A protocol for the development and preliminary testing of an online prostate cancer health information and clinical trial matching tool.” It described how the researchers worked with SOM Tech to develop what they called the Trial Library.

The researchers tested early versions of the Trial Library at the Helen Diller Family Comprehensive Cancer Center (HDFCCC) at UCSF.

Approach

Jonathan Prugh of SOM Tech served as the lead designer. He started with a site that already exists, ClinicalTrials.gov, a database of privately and publicly funded clinical studies conducted around the world, run by the U.S, National Library of Medicine, part of the National Institutes of Health. (In September 2022, the site listed 427,974 research studies in all 50 states and in 221 countries.)

“You can filter those down and map them,” Prugh said, which allows people to see what trials are near them. That’s important for the people that Borno’s team was trying to reach, Prugh said, because “travel is a big barrier to get into clinical trials. A lot of these folks can't afford to hop on a plane and go to a trial in New York from California. They need trials that are nearby.”

To assist in that effort, Prugh built a mapping feature into the site, so patients could easily sort trials by location.

Borno also gave Prugh the mandate to design a site that would address the linguistic and literacy needs of broader patient populations.

Prugh built mockups of what a web site might look like that pulled information from ClinicalTrials.gov. Borno and her team would offer feedback, suggesting new features or commenting on what wasn’t working, and Prugh would create a new iteration.

Borno also set up a panel of her prostate cancer patients, who formed focus groups of sorts, reviewing the proposed web sites and suggesting changes on Zoom calls. “It was helpful to bring in people with different perspectives to take a look at it,” Prugh says.

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Solution

The Trial Library will ultimately be a publicly accessible web site, but it remains restricted to certain patients at the moment.

As it stands now, the Trial Library is built for a prostate cancer study, but it’s still in the early stages. The site is designed to be generic enough that any researcher could adapt it to use it for any clinical study, no matter the disease.

The Trial Library tool was designed to be easily accessible on any computer with Internet connectivity, and a concerted effort was made during the design process to also make Trial Library easy to navigate and user-friendly on smartphones. Prugh incorporate elements of “human-centered design” to make sure the user experience stayed front and center.

Any patient should be able to go online and see what trials are available. If there’s a trial they’re interested in, they can show their physician and discuss the pros and cons of participating.

One section of the web site was originally devoted to patient stories, and was promoted on the home page. But several patients offering feedback said they didn’t want to read those, while only a few did, so that the designers downplayed that aspect.

Borno and her colleagues tested the Trial Library through their own clinical trial, bringing in 66 men with prostate cancer to test the model, and clearing them for study through all the typical channels for institutional review and safety protocols. Participants used the web site and then filled out questionnaires about their experience. The study also looked at whether participants talked to their doctors about clinical trials, deeming that a measure of success.

Thanks to that and other studies, Borno and her team learned what she wrote were three critical lessons:

  • Healthcare providers are gatekeepers who need tools to better serve their patients. Only 13 percent of US oncologists participate in clinical research, the majority at large urban academic medical centers. Yet 85 percent of cancer treatment and diagnosis takes place in community settings. And most people learn about clinical trials from their provider. Putting it all together, a tool like the Trial Library can help community oncologists learn about clinical trials that could benefit their patients.
  • Accessible clinical trial information empowers patients. Most cancer information is hard to understand and not written for the layperson. If the material is more easily understood, more people will read it and participate in trials.
  • Technology solutions need integration with human navigation to address social determinants of health. How do you get under-represented people to participate in trials? You need other people to reach out to them, make a human connection, and show them the benefit.

With these lessons in mind, Borno has spun Trial Library out of UCSF and into its own public benefit company with, according to its web site, “a mission to improve health equity by expanding access to cancer precision medicine.” She’s raised money and is serving as CEO.

Written by Dan Fost for SOM Tech (2022)

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