Promoting participation in clinical trials
Roughly 75 percent of all clinical trials conducted in the United States each year fail, and the number-one reason for this failure is the inability to recruit enough participants. With help from a Clinical and Translational Science Award (CTSA) from the National Institutes of Health, the University at Buffalo is working to solve this problem.
“Over the past 30 years, progress in basic biomedical sciences has been spectacular,” said Timothy Murphy, senior associate dean for clinical and translational research in the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo and director of the University’s Clinical and Translational Research Center (CTRC). “But if you look at how effectively and successfully those basic biomedical sciences have been translated into health care, it’s not improving at anywhere near the same rate as basic biomedical sciences. New drugs are being approved by the FDA, but the number approved in 2013 is the same number approved in 1980 —it’s a flat curve.”
According to Murphy, it takes an average of 14 years and $2 billion to take a drug from identification to FDA approval, and the biggest bottleneck to this process is getting and keeping enough patient participants in clinical trials. In addition, he noted, those patients who do participate do not adequately reflect the population of the United States.
“Ninety-five percent of all participants in NIH-funded clinical trials today are Caucasian,” said Murphy. “The population of the city of Buffalo in 2016 is about 50 percent underrepresented minorities—39 percent African American, 10 or 11 percent Hispanic, and 1 percent Native American. If you look at the U.S. census projections for the year 2050, it’s projected that the entire country in 2050 will comprise 50 percent underrepresented minorities. We view our community in Buffalo as a population of the future, so if we can solve the problems of enrolling people in clinical trials in Buffalo, then those solutions are going to be applicable nationwide.”
The Patient Voices Network
One way the CTRC at UB is solving the problem of public participation in clinical trials is by involving patients in all aspects of the clinical trial process through a program called the Patient Voices Network, a group of patients in the community who have joined to become part of the research team.
“We believe that people in the community need to be involved in all phases of clinical research, including driving the research agenda, participating on research teams, and recruiting new patient participants in clinical trials,” said Murphy.
Laurene Tumiel-Berhalter, associate professor in the Department of Family Medicine and director of community translational research leads the Patient Voices Network, which began in 2010. “The network is incredibly important because it brings a reality to research that allows us to ask the right questions and measure the right outcomes,” she said. “It gives patients a voice in discussing issues around the delivery of health care and the strengths and weaknesses of their communities.”
Tumiel-Berhalter’s own research on the self-management of chronic care, the empowerment of patients to be part of their care teams, and the encouragement of cancer screening has benefited greatly from the network. “We’ve had over 80 percent recruitment and retention of participants in our interventions,” she said. “Other patients really relate to the network’s members; people listen to them.” Members of the network receive nominal compensation when they participate in funded projects.
According to Murphy, getting people involved in clinical trials can help improve their health outcomes. “Not only do the patients receive experimental treatments, but they also end up having regular contact with a health care professional. People, especially those who experience health disparities, may not otherwise have that regular contact.”
Trial by Finger
Another way UB aims to recruit more participants in its clinical trials is through the development of a cell phone app that puts all available clinical trials at patients’ fingertips.
Peter L. Elkin, professor and chair of the UB Department of Biomedical Informatics and professor of internal medicine, developed the app, which displays all potential nearby trials. The app includes basic information about the trial, including eligibility criteria. Hitting one button notifies the trial coordinators that a person would like to be contacted to learn more about the study.
The team currently is planning to test the effectiveness of the cell phone app in recruiting patients to clinical trials. The researchers will perform a study in which half of the participants will have access to the cell phone app and the other half will not. “It sounds really cool and innovative, but we need to show that it works in a pilot study before it can be rolled out widely and hopefully make a real difference,” said Murphy.
Ultimately, UB’s effort to increase participation is clinical trials is a “different strokes for different folks” approach. Murphy noted, “One thing that’s clear is we have to do lots of different things to do a better job of getting more people enrolled in clinical research.”
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