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The cancer trial next door

The ideas and innovators shaping health care
Mar 26, 2024 View in browser
 
Future Pulse

By Ruth Reader, Erin Schumaker and Carmen Paun

CONNECTING THE DOTS

SAN FRANCISCO - AUGUST 18:  Eighteen-year-old cancer patient Patrick McGill lies in his hospital bed while receiving IV chemotherapy treatment for a rare form of cancer at the UCSF Comprehensive Cancer Center Childrens Hospital August 18, 2005 in San Francisco, California. The UCSF Comprehensive Cancer Center continues to use the latest research and technology to battle cancer and was recently   rated 16th best cancer center in the nation by US News and World Report.  (Photo by Justin Sullivan/Getty Images)

Researchers found a majority of cancer trials sites in the U.S. were in more affluent areas that had a higher proportion of white residents than the national average. Justin Sullivan | Getty Images

A cadre of cancer researchers thinks they’ve landed on a way to diversify clinical trials.

The problem: Low-income people and people of color are underrepresented in clinical trials, including cancer studies. One limiting factor is distance since, on average, people are less likely to sign up for a clinical trial more than 30 minutes from where they live, according to a new report in JAMA Oncology.

“The biggest reason patients don’t enroll is they’re not asked,” Dr. Karen Winkfield, co-author of the paper, said. “They aren’t asked because there may not be clinical trials close to them,” Winkfield, executive director of the Meharry-Vanderbilt Alliance and a National Cancer Advisory Board member, said in a statement.

By the numbers: The researchers used data from the U.S. Census Bureau, the American Community Survey, the National Trial Registry, OpenStreetMap and other sources to create population maps around active cancer trial sites.

They found that 78 major U.S. cancer trial sites, which represent 94 percent of all cancer trials, were in more affluent areas that had a higher proportion of white residents than the national average.

The fix: Using their new data tool, the researchers analyzed the areas around the cancer sites to identify health care facilities serving more diverse communities in neighboring areas. The researchers theorize that cancer trial sites could have more diverse participants if they were to collaborate with nearby hospitals and community health centers.

“If you wanted to diversify the population for a clinical trial, you could use our tool to generate maps with whatever demographics you want,” Dr. Hassal Lee, lead study author and clinical fellow at Cold Spring Harbor Laboratory, said in a statement. “It’s transferable to any U.S. area as long as you have Census data.”

What’s next: The researchers want to analyze other trials that aren’t related to cancer and test their approach in the real world by applying the design to new cancer trials.

WELCOME TO FUTURE PULSE

A nature overlook in Hillsboro Peak, New Mexico.

Hillsboro Peak, New Mexico. | Erin Schumaker/POLITICO

This is where we explore the ideas and innovators shaping health care.

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Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@politico.com, Daniel Payne at dpayne@politico.com, Ruth Reader at rreader@politico.com or Erin Schumaker at eschumaker@politico.com.

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FORWARD THINKING

ALTAMONTE SPRINGS, FLORIDA - DECEMBER 16:  Vials of smallpox vaccine sit on a counter before a vaccination December 16, 2002 at Mid-Florida Biologicals in Altamonte Springs, Florida. The health center is part of a 16-clinic trial study looking at smallpox vaccinations. According to Dr. Ronald Brown of Mid-Florida Biologicals,, there have been no reports of adverse side effects due to the vaccine among the 2,500 local   participants in the study . (Photo by Chris Livingston/Getty Images)

The U.S. should develop safer, single-dose vaccines and a diverse set of treatment options for smallpox, NASEM recommended in a report. Chris Livingston | Getty Images

Smallpox may have been eradicated, but the U.S. still needs to prepare for a potential reemergence, the National Academies of Sciences, Engineering and Medicine said in a new report today.

How so: Researchers could use advances in genome amplification, sequencing, editing and synthesis to recreate the live smallpox virus from available information, raising the risk of a release, either accidental or intentional, according to the report, sponsored by the HHS Administration for Strategic Preparedness and Response.

The risks from viruses from the same family, called orthopoxviruses, are rising, as the world sees increasing cases in recent years, such as the first death caused by Alaskapox and the ongoing mpox outbreak in the Democratic Republic of Congo, which killed more than 270 people.

Here’s what NASEM recommends the U.S. government do, based on the lessons from the response to the Covid-19 pandemic and the global mpox outbreak:

— Strengthen laboratory response system, continue developing tests and genomic surveillance capabilities

— Develop safer, single-dose vaccines and a diverse set of treatment options

— Be ready to respond to other orthopoxviruses outbreaks by supporting the development and licensing of vaccines, tests and treatments

— Continue research with the live variola virus, which causes smallpox, to maintain preparedness against smallpox or other similar viruses. The U.S. and Russia are the only countries with stocks of the virus

— Develop flexible plans to stockpile and distribute vaccines, tests and treatments against smallpox, taking into account different potential outbreak scenarios

— Share the burden of developing newer vaccines, tests and treatments for smallpox and similar viruses with other nations and organizations

— Create a global platform to make smallpox health products available, allowing other nations to respond to an international outbreak, so they don’t all depend on the U.S.

PROBLEM SOLVERS

Anti-abortion activists and abortion rights activists are seen outside the U.S. Supreme Court.

In the six months following the Dobbs v. Jackson decision, telemedicine groups provided well over double the amount of medication abortion they were supplying before the Supreme Court’s decision. | Francis Chung/POLITICO

The Supreme Court heard oral arguments on medication abortion Tuesday, one day after the publication of a new study that found the practice surged after the Dobbs decision.

Telemedicine has proven key to facilitating abortions in the face of state abortion bans. A significant increase in medication abortion has made its way to patients through online and community networks, according to a study published in JAMA.

In the six months after the Dobbs v. Jackson decision, telemedicine groups provided more than double the amount of medication abortion they were supplying before the Supreme Court’s decision. Meanwhile, online vendors and pharmacies more than tripled the amount of medication abortion they dispensed.

In total, across online providers and community networks, some 28,000 additional people received medication abortion in the months after Dobbs.

Why it matters: The plaintiff in FDA v. Alliance for Hippocratic Medicine seeks to reprise restrictions on medication abortion. AHM senior counsel Erin Hawley said in her opening remarks that the FDA relied on flawed data when it decided to change the rules guarding mifepristone and failed to explain the effects of removing the protections around the drug.

The FDA says less than half of one percent of those who take the drug experience adverse events.

Medication abortion is increasingly popular. The two-pill regimen now accounts for 63 percent of all abortions, according to the Guttmacher Institute, a reproductive rights policy group.

Abortion is banned in 14 states and restricted in seven others.

“This case, quite specifically, could do real harm to telemedicine,” Julie Kay, executive director of the Abortion Coalition for Telemedicine, said.

What’s next: The case also calls into question the FDA’s judgment, which could lead to more lawsuits challenging the agency’s drug approvals.

“The relief entered below would severely disrupt the federal system for developing and approving drugs, harming the agency and pharmaceutical industry,” said Solicitor General Elizabeth Prelogar.

 

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