From memory preservation to early-stage lung cancer detection, researchers have hundreds of potentially life-changing medical advances waiting to reach the public.
As an academic medical center, Keck Medicine of USC makes these medical discoveries happen through the rigorous testing of clinical trials.
Yet testing new therapies for safety and effectiveness can take years. Across the nation, some clinical trials are never completed, for reasons that have nothing to do with the treatment itself. Some studies are slow to get started because finding and enrolling qualified participants can be challenging. With the number of U.S. clinical trials growing rapidly during the last decade, it can be tough to recruit enough patients to fill them. Likewise, patients drop out of trials, which can slow progress or derail the trial completely. It’s a problem that vexes health advocates and drug companies.
But researchers are trying to overcome these hurdles by going digital.
“By developing new technology, we are making our clinical trials faster, more efficient,” says Thomas A. Buchanan, vice dean for research at the Keck School of Medicine of USC and director of the Southern California Clinical and Translational Science Institute (SC CTSI). Much of the new technology being developed at SC CTSI is aimed at finding qualified candidates and filling clinical trials as quickly and efficiently as possible.
The ultimate aim is to speed promising and safe treatments to more patients sooner.
HOW IS TECHNOLOGY CHANGING CLINICAL TRIALS?
It can take a long time to sift through thousands of medical records looking for patients who are right for a clinical trial. Each study of a new drug or device has its own set of specific requirements. To join a trial for a new chemotherapy drug, for example, patients might need to have tried a list of other medications first. Or to take part in a study on a new breast cancer detection technology, participants may have to have dense breast tissue. Matching patients to trials can be a painstaking process.
But USC’s Daniella Meeker may have a shortcut. The director of the Clinical Research Informatics program at SC CTSI works with researchers to develop search tools that can quickly scan electronic medical records to see how many Keck Medicine and Children’s Hospital Los Angeles (CHLA) patients meet the trials’ criteria.
Researchers can screen for patients with a specific diagnosis, procedure, age range and results on blood tests. Knowing the number of patients in the area that meet the criteria can deter-mine whether and how quickly a trial can be filled, says Meeker, who is also an assistant professor of preventive medicine. If a trial is launched, the researcher may also be able to use those medical records, if approved by the Institutional Review Board, to reach out to patient volunteers who might be interested in participating.
“Finding volunteers for clinical trials is a critical need to help advance medical care, and we believe technology can help,” says Anthony El-Khoueiry, associate professor of clinical medicine and medical director of the clinical investigations support office at USC Norris Comprehensive Cancer Center.
Much of the new technology being developed at SC CTSI is aimed at finding qualified candidates and filling clinical trials as quickly and efficiently as possible.
Why are volunteers for clinical trials hard to find? He and his colleagues have some ideas.
One is the sheer size of USC’s medical enterprise. The number of clinical trials in progress or in development at Keck Medicine on any given day requires a huge number of volunteers. A recent tally counted more than 600 clinical studies underway at USC.
With so many clinical trials taking place, some patients simply may not know how and where to find one. To spread the word, SC CTSI goes where they know patients are: social media.
TAKE TRIALS TO THE PATIENTS
Patients today turn to social media to find support and a community that can share information about their disease, notes Katja Reuter, assistant professor of clinical preventive medicine and director of digital innovation and communication at SC CTSI.
To tap into these groups, Reuter and a team from the SC CTSI created Trial Promoter, an open-source tool that sends out automated posts on social media such as Twitter, Facebook and Instagram about new and ongoing clinical trials. It also collects data on how the messages are received and shared.
Reuter also launched a project with USC Norris to use Twitter in a more targeted way in the Los Angeles area, locating and messaging users with any of six types of cancer—breast, colon, prostate, kidney and lung cancer, as well as lymphoma — to inform them about recruitment for clinical trials.
Then there’s the challenge all academic health professionals face: countering widely held misconceptions about clinical trials. Some patients assume that clinical studies are only a last resort for terminal diseases. Or they fear that they might receive a placebo instead of real medication, potentially worsening their condition.
In reality, clinical trials can be used in a variety of ways, and they draw upon a wide swath of patient volunteers. Some trials evaluate new devices. Others test drugs that are already used to treat other diseases. And sometimes, clinical trials evaluate whether therapies can prevent disease among healthy participants.
Not every trial uses placebos, either. Patient volunteers typically receive either a standard treatment for their disease or the drug that’s under investigation — or both. Strict guidelines established by organizations like the U.S. Food and Drug Administration and Keck Medicine’s Institutional Review Board ensure that trials are safe and ethical.
STAY THE COURSE
In some ways, being in Los Angeles gives Keck Medicine a huge advantage in recruiting participants. The health system’s long history as a partner in communities across Los Angeles County has provided invaluable insight into the health needs and concerns of Angelenos from different cultures. This deep knowledge bank and cultural fluency is one reason Keck Medicine recruits a diverse cross section of patients into its studies, El-Khoueiry says. Recruiting patients from a variety of backgrounds is important because patients may have different side effects according to variations in their genetic makeup, which can be linked to race and gender
Yet researchers say they still must increase participation among certain groups to make sure that they can find treatments that will help them. African-American participation in clinical trials for Alzheimer’s disease is notably low, for example. Karen Lincoln, an associate professor at the USC Suzanne Dworak-Peck School of Social Work, aims to boost their participation in clinical trials through another piece of common technology: the smartphone.
We are trying a lot of new approaches because we want to speed up the pace of clinical trials. All new drugs have to go through testing, and we are trying to find the fastest way.Thomas Buchanan
Lincoln’s strategy is to send daily text messages about brain health and clinical trials to older African-Americans in the Los Angeles area. She hopes that providing educational messages via text results in a greater comfort with clinical trials and increased participation in Alzheimer’s research.
Smartphones and devices could also help with another challenge related to clinical trials: staying organized.
Most clinical trials require some time commitment from each patient volunteer. That could include regular doctor visits, taking detailed notes and sometimes sticking to a strict medication schedule.
The time commitment is a major reason that patients leave trials. But Jorge Nieva, associate professor of clinical medicine at the Keck School of Medicine of USC, hopes to help simplify that process. Nieva and other USC researchers developed a Fitbit-like device to remotely collect data on patients, such as their heart rate. The monitor delivers a steady stream of information electronically so that patients no longer need to keep notes or travel as often to doctors’ offices.
Devices like these also provide participants with added safety. Key information, like whether a patient is staying active or has weak vital signs, can signal that they’re doing well on the clinical trial or, alternately, that they need to see the doctor.
Buchanan adds that technology is also going to play a role in patient education about clinical trials. The USC team has developed avatars — digital representations of real people, much like characters in video games. These avatars will soon “talk” on screen with CHLA’s young patients to answer questions about clinical trials in an unintimidating way. Doing a better job of educating patients should also help demystify clinical trials, which may result in more people volunteering.
“We are trying a lot of new approaches because we want to speed up the pace of clinical trials,” Buchanan says. “All new drugs have to go through testing, and we are trying to find the fastest way.”