As an obstetrician and gynecologist at UC San Francisco, Vanessa Jacoby, MD, knows firsthand how crucial reliable research findings are to medical care. As a researcher, she also knows the challenges of designing and carrying out new studies. One of the biggest of those challenges is recruiting participants. To help researchers and volunteers connect, Jacoby partnered with a team at UCSF to design a new online UCSF-based clinical trial finder. She talked with us about the website and how it could serve as a model for other local research communities around the country.
First, how serious is the problem of under-enrollment in clinical trials?
Very serious. Just to give you an idea, one recent study of 153 proposed clinical trials found that 48 percent failed to meet their enrollment target, and 11 percent didn’t enroll a single participant. A 2010 report from the US Institute of Medicine found that among pharmaceutical industry-sponsored studies, 27 percent fail to enroll any subjects, and 75 percent fail to enroll the target number. That report also showed that research is often delayed while researchers try to recruit enough volunteers. In fact, 90 percent of all clinical trials worldwide fail to enroll patients within the target amount of time, according to the report.
What are the consequences of this?
Let me mention three. If you can’t recruit enough people, you may not be able to answer the scientific question you hoped to address. Let’s say you set up a study to test whether a new medication can help control high blood pressure. If you cannot recruit the number of study volunteers you intended to enroll, you may never know if this promising new medication is effective. There’s an economic consequence as well. Academic institutions, funding agencies, pharmaceutical companies, and others invest a lot of time and money in designing and running clinical trials. If you can’t recruit enough volunteers in a timely fashion to successfully complete the study, it may have a significant economic burden on your group with low return on the investment. And third, there are ethical consequences. When we as researchers recruit people for a study, we have a kind of social contract with them. Volunteers offer their time and participation. In return, we promise to pursue the goal of the study—testing to see if a particular medication works, for example. But if the trial is under-enrolled, we may not be able to make good on that social contract. And as researchers, we take that very seriously.
Why is it so difficult to enroll patients?
There are many reasons. One of the main reasons is that it isn’t easy for willing participants to connect with open and available studies. The NIH has a government-funded website, ClinicalTrials.gov, which lists tens of thousands of clinical trials open for enrollment being conducted in the U.S. and many other countries. It’s a great resource. But it is difficult for lay people to search through to find a study that might be appropriate for them. And because the government site includes studies from all over the world, it’s difficult for someone in the San Francisco Bay Area, for instance, to connect with a study being conducted here. The other problem is that the descriptions are written by researchers, and we’re not always that good at explaining things in terms the general public will understand. Many studies have complicated eligibility criteria, which make it even more difficult for people to find studies that may be open and appropriate for them.
How does the new UCSF clinical trial tool make it easier?
First, our new website includes only clinical trials being conducted by UCSF researchers. So right away, it’s much easier to navigate and to connect with a study that you might be able to participate in, right here in the Bay Area. The federal site lists over 230,000 studies in the U.S. and roughly 190 other countries. As of last December, our clinical trial site listed 1,330 trials being conducted by UCSF researchers, 666 of which were open and recruiting. That’s a much more manageable number to search for studies that interest you. The website makes these studies easier to find by search engines, so if people are researching a particular condition online, and they are located in the Bay Area, it’s likely that applicable UCSF studies will appear in their search results. We’re also looking at ways to help researchers tweak the descriptions of their research to make them easier for potential participants to understand. Additionally, the new site lets people contact the research team directly. You can click a button, and it will send a message to the research team to contact you once they have your permission. The UCSF clinical trial site also gives some general criteria for each study, which people can use as a sort of prescreen before they contact the study team. Finally, we’ve included general information about participating in a clinical trial, to help people understand what they can expect as a research volunteer.
Do you have plans to expand the site beyond UCSF?
UCSF’s Clinical and Translational Science Institute, which built the trial finder website, is already looking at expanding the site to include clinical trials from all five of the medical centers that are part of the University of California system. And hopefully, a site like ours could serve as a model for similar sites in other research communities around the country.
How will you know if the site is working to connect researchers and participants?
We’re tracking how many people visit and search the site. And over time, we’ll be able to gauge whether researchers at UCSF are having better success at recruiting for their studies. One thing I want to mention is that although the studies are usually looking for people with a particular condition, in order to test a new treatment, many studies are also looking for healthy volunteers. Sometimes we need healthy volunteers to study how a new medication is metabolized by the body, for instance, before we give it to people who are sick, or we need healthy volunteers to serve as a control group. So there are many opportunities for people to help advance medical science, even if they don’t have a particular condition.
This opinion does not necessarily reflect the views of the UC Berkeley School of Public Health or of the Editorial Board at BerkeleyWellness.com.
Also see 3 Types of Research Studies.