Clinical trials that are key to developing new treatments and medical devices have a lot of problems.
Researchers struggle to recruit participants, and the people who agree to take part are often not diverse enough. That can undermine the results if drugs or devices affect different people in different ways.
The Covid-19 pandemic, with the pressing need it created to develop treatments and vaccines, pushed clinical trial modernization efforts forward. Millions in venture funding have poured into the sector.
The 21st Century Cures Act of 2016 aimed to improve trials by reducing administrative burdens, and the FDA has made improving trials a priority over the past several years. Verily, a subsidiary of Google parent company Alphabet, hopes to be part of the solution.
Ben caught up with Amy Abernethy, the former No. 2 at the Food and Drug Administration and now president of Verily’s clinical research business. They discussed barriers to improving trials, the new Advanced Research Projects Agency for Health and more.
The interview is edited for length and clarity.
What is the state of clinical trials right now, and what needs to change?
We learned in Covid that our discovery engines were really working very, very fast. But clinical trials still are circa 1995. We also learned in Covid that we have the opportunity to shift how we do clinical trials, and that will speed up the process.
I see us moving towards clinical trials that include data that already exist in the system, like electronic health records and claims data. I see clinical trials leveraging new types of data, such as sensors in a watch to help you understand mobility. We’re going to see study designs that also leverage formalized clinical trials followed by longitudinal follow-up [tracking people over time]. There will be many new study designs.
What are the biggest obstacles to modernizing clinical trials?
There are lots of obstacles to modernizing clinical trials, but most of them I see as surmountable.
If we’re going to leverage all available data, we’ve got to solve for the data quality mismatches that happen. Another critical thing to solve is we need to make clinical trials low-burden for participants. It shouldn’t get in the way of living. We need to make sure that clinical trials fit in the lives of people of all backgrounds so that clinical trials are representative of real populations.
Can you leverage data to better pair patients with trials?
Recruitment is one of the hardest things in clinical trials. Oftentimes, about a third of the study budget goes to recruitment because it’s hard to find the right participant at the right moment.
You can’t just have one way of trying to solve it.
Yes, we think about the requirements of clinical trials and how to match that to the features of individual people who may be appropriate. But we also include digital marketing and campaigns to reach people and call centers and white-glove service to help that last mile of matching patients to trials.
What are the biggest obstacles to Verily’s success?
One of them is participant burden and a focus on patient centricity. I think about how digital and software and user experience works for us and other parts of our lives. We need to make sure that we bring the best of software design and fit that into workflow and life workflow in a way that’s completely patient-centric.
Another one is longitudinally. Clinical trials of the future are not going to be one week or two weeks long. We are going to follow people for long periods of time. We’re going to need to solve: How do people stay in trials for long periods of time?
President Joe Biden’s biomedical research agency, the Advanced Research Projects Agency for Health, is beginning to take shape with ambitious goals. What does it need to do to find new cures?
As they look to novel solutions in clinical trials and evidence generation, they’re going to need to think about leveraging data in new ways, including all available data, prospectively understanding and following products across time, making sure that we consent people to participate in efficient ways and that it’s fully transparent.
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Reducing air pollution could help combat dementia, according to a study recently published in the journal PNAS.
What’s the evidence? Researchers at the Emory University School of Public Health and Georgia Tech’s School of Earth and Atmospheric Sciences, among other institutions, explored whether there’s a link between air pollution and dementia by examining Medicare claims for 19 million people and estimates of air pollution levels in the areas where those people lived.
Sulfate and black carbon pollution showed the strongest association with dementia, followed by organic matter and ammonium. Nitrate and soil dust had relatively little linkage.
Why it matters: Nearly 6 million people in the U.S. live with dementia, which encompasses Alzheimer’s disease and other conditions that damage the brain, typically causing memory loss and the inability to think clearly.
That number is expected to rise to 14 million by 2060, according to the Alzheimer’s Association, with Hispanic and Black people most affected.
Public policy ideas: Reducing the concentration of fine particulate matter in the air, especially from traffic and sulfur-containing fossil fuel combustion, could have a significant public health impact, the researchers said.
More people are using smartphone apps they hope will improve their mental health.
But a new study in JAMA Network Open by researchers from Beth Israel Deaconess Medical Center in Boston says the apps have room for improvement.
The researchers found:
— Just 2 percent of the apps they studied were connected to electronic health records.
— Nearly half of the apps studied shared health data with third parties.
— It’s unclear whether the apps’ privacy policies are “accessible by most users.”
— Just half of the apps had an accessibility feature.
— Few apps were designed to treat serious illnesses.
The researchers also pointed to previous research showing that less than 5 percent of mental health apps have randomized clinical trials or other real-world evidence to back up the help they’re offering.
Among the apps the researchers studied, the most common aimed to treat substance abuse related to smoking or tobacco, stress and anxiety, and “nonserious mood disorders.”
“Overall, there is a lack of clinically supported mental health apps,” the researchers wrote. “The current app marketplaces lack diversity in their offerings and fail to implement potentially high-impact features.”