Fri Jul 28 2023 00:00:00 GMT+0300 (Eastern European Summer Time)
Clinical Trials Are Now At Your Local Drugstore. What That Means For You
The next time you're in the drugstore, you might be able to do more than stock up on aspirin and toothpaste: National pharmacy chains have started clinical trial divisions to identify customers who could help usher in the next generation of lifesaving treatments.
It's part of a trend in decentralized clinical trials that exploded during the pandemic, when researchers had to figure out how to continue critical testing during lockdowns.
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"COVID-19 was definitely the impetus for reevaluating how we did clinical trials," said Ramita Tandon, chief clinical trials officer at Walgreens, which has installed special clinical trial centers at 15 pharmacy locations nationwide.
"When everything was shut down, retail pharmacies were still open and were able to administer vaccines across the US," Tandon told CNET. "I think the clinical trial industry quickly realized this was a way to reach more people in general and to reach more-diverse populations in particular."
What is a clinical trial?Any treatment seeking approval by the US Food and Drug Administration, whether it's a cholesterol-lowering drug or a pacemaker, has to go through the clinical trial process, where researchers enlist volunteers to test its efficacy and safety. Also known as interventional studies, these tests can be sponsored by pharmaceutical companies, federal agencies like the National Institutes of Health or even individual doctors, scientists or academics.
Clinical trials are often designed to determine if a new treatment is more effective or has fewer side effects than an existing therapy, according to the National Institute on Aging, though they may also be used to uncover new ways to diagnose a disease, prevent health problems or improve the quality of life for people living with chronic conditions.
In January, there were nearly 39,000 active clinical trials in the US, according to the National Library of Medicine.
It's a big business -- one that generated nearly $28 billion in 2022. But historically, finding qualified participants and keeping them enrolled has been a major obstacle. Being a test subject can be inconvenient and time-consuming: Participants traveled an average of 67 miles each way last year to reach a testing site.
Unsurprisingly, 80% of clinical trials fail to meet their enrollment target and timelines, costing drug developers millions of dollars in lost revenue and delaying the development of critical drugs, devices and other treatments.
Hoping to address that need, Walgreens, Walmart, CVS and Kroger have all launched clinical trials divisions in the last two years.
Walgreens has launched about a dozen clinical trials since insituting its program in June 2022. Getty ImagesThe pharmacies say they're focused on making clinical trials more convenient and diverse and improving health outcomes for their customers.
"If you see the trial is at an academic institution that's 30, 40 miles away, you're going to say, 'Forget it. It's too far,'" Tandon told CNET. "But if you can go to a Walgreens that's maybe five miles away, you're more likely to participate and complete the trial."
But there's no guarantee of success: One major player has already canceled its clinical trial program. And the retailers' paid partnerships with major pharmaceutical companies may raise questions about patient privacy.
Typically, the pharmacy will reach out to a customer who's opted in to receive communications and who meets initial testing criteria. If they're interested, the participant will come into the nearest branch that's set up with a clinical trial center and be given more details and a prescreening evaluation.
Once the trial begins, the patient may undergo diagnostics and have blood drawn at the pharmacy. Depending on what the client company has requested, they may be given wearable digital devices to monitor them at home.
Dr. Amir Kalali, a physician scientist and co-founder of the Decentralized Trials & Research Alliance, says retail pharmacies also have the advantage of an existing relationship with the customer.
"That can make the difference in building trust," Kalali said, "when you're getting someone to understand what's involved or trying to have them follow through and complete a trial."
Increasing diversity in clinical trialsBuilding on a pharmacy's customer base has another benefit: Pfizer, Gilead and other biopharmaceutical companies are eager to diversify their patient pool. Though less than 60% of the US population is white, white people make up 75% of clinical testing participants, according to data from the FDA.
Black, Hispanic and Asian people are all underrepresented in medical research, even though 20% of drugs demonstrate some difference in response among ethnic groups.
And even though more than half of cancer patients are women, only 41% of participants in oncology trials are female, according to research published last year in Contemporary Clinical Trials.
Advocates have called for better representation for years. Passed in December as part of the 2023 omnibus spending bill, The Diverse and Equitable Participation in Clinical Trials (DEPICT) Act requires researchers to have a strategy for introducing more diversity into their recruiting efforts. With thousands of locations, the big pharmacies say, they can leverage both their convenience and their ability to reach underserved groups.
When Walmart launched its Healthcare Research Institute to begin trials in October 2022, it declared that the focus would be on "innovative interventions and medications that can make a difference in underrepresented communities," including women, older adults, rural residents and minorities.
There are more than 5,000 Walmart pharmacies in the US and Puerto Rico. According to the company, 4,000 are in neighborhoods that lack access to primary care services.
"This puts Walmart in a unique position to reach traditionally underrepresented people and offer access to healthcare research where they shop for everyday essentials," John Wigneswaran, Walmart's chief medical officer, told CNET via email.
"We are already in our local communities," Wigneswaran added. "We have relationships with thousands of customers and are able to take our approach as a trusted voice in the community."
Wigneswaran said Walmart is initially focused "on chronic conditions, such as diabetes, cardiovascular disease, COVID-19 and asthma," but that additional diseases, including HIV, dementia and obesity, are also on its radar for future clinical trials.
Privacy concernsTaking clinical research out of the lab and into the neighborhood drugstore is a big step, according to Moe Alsumidaie, founder of CliniBiz, which works to make studies more efficient and affordable. Staff have to be trained and the pharmacies themselves need to be outfitted with private exam rooms and specialized research equipment.
"It's not like sitting in a chair and waiting for your vaccine to be administered," Alsumidaie said. "Clinical trials are much more involved."
Of course, the pharmacies are well compensated for their efforts. Tandon described Walgreens' clinical trial program as "a fully baked revenue-generating business model."
"When a manufacturer reaches out to Walgreens, there's a menu of services they can pick and choose from," Tandon said. "And there's a fee structure involved."
To create a list of candidates, pharmacies mine data they have about their customers' age, gender and medication history. They don't keep records on race or ethnicity, but knowing a customer's address can help narrow their demographic information.
Walmart's Wigneswaran said that securing protected health information and maintaining trust with patients "are top priorities."
And according to the FDA, retail pharmacies are subject to the same regulatory requirements as any other research facility.
"The FDA may conduct inspections to ensure that trials conducted in retail pharmacies are conducted in accordance with regulatory requirements, including those pertaining to the protection of the rights, safety, and welfare of trial participants," the agency told CNET in an email.
To support the expansion, the US Food and Drug Administration released additional draft guidance in May.
Kalali said concerns about privacy are really part of a larger conversation.
Customer information "is already being sold by pharmacies to lots of data aggregators," he told CNET. "People are monetizing patient data as we speak. I don't believe decentralized trials at pharmacies are any different in terms of how we treat patients' information. The real question is, 'Should patients own their own health data?'"
The future of decentralized clinical trialsKroger, which operates nearly 1,200 pharmacies in the US, announced its first clinical trial partnership in January, a partnership with Persephone Biosciences to find candidates for a study on gut health and its impact on colorectal cancer.
According to the American Cancer Society, African Americans are about 20% more likely to get colon cancer compared with the general population, and about 40% more likely to die from it.
The supermarket chain declined to comment about its program, but in a release, Kroger Health's chief commercial officer, Jim Kirby, said the cancer trial will be the first of many "that will utilize us as an alternative to the traditional clinical trial and research organization model."
Walgreens, which launched its clinical trial business in June 2022, has about a dozen studies in various stages of development. One that's made headlines involves the antibody PRX012, which has been fast-tracked by the FDA as a potential treatment for Alzheimer's disease.
In all, more than 2 million Walgreens customers have been contacted about participating in clinical trials, Tandon said, and the chain has already seen a positive trend in recruiting diverse participants: By June 2023, African Americans represented 17% of patients it had enrolled in clinical trials, while Latinos accounted for 15%.
CVS Health was the first to launch a clinical trials program, back in May 2021. But the nation's largest pharmacy chain has already announced it's getting out of the business after just two years. It expects to fully phase out its services by the end of 2024.
Asked why, CVS said only that, "We continually evaluate our portfolio of assets to ensure they are aligned with our long-term strategic priorities."
The clinical trials business isn't for everyone, Alsumidaie said. It's a highly regulated industry that involves lots of institutional oversight, careful storage of sensitive information and the potential for adverse reactions among patients.
But CVS' decision shouldn't be taken as a sign it isn't a viable avenue, he added.
"It could be due to a variety of factors -- strategic realignment, competition, operational hurdles, financial implications and different industry trends," Alsumidaie said.
Kalali is also optimistic about pharmacy chains' future involvement in decentralized clinical trials. The goal, he said, isn't to replace traditional test sites, but to give patients options.
"What we'd like to see is a situation where some things you have to go to a physical location for, and other things you can be assessed at home," he said. "That's what we're really aiming toward: for patients to fit a trial into their lives, as opposed to them having to fit into the protocol."
The Rectal Cancer Clinical Trial At MSK That Changed Everything For Its Patients
"I'd always dreamed of having a huge family."
For Kelly Spill, learning she had rectal cancer didn't only mean facing a potentially life-threatening disease.
The diagnosis also threatened many of the things she held dearest in life.
Kelly was diagnosed at 28, just months after giving birth to her son, Jayce. She and her husband, John Bonito, were heartbroken to learn that the standard treatment for rectal cancer — usually a combination of surgery, radiation, and chemotherapy — could make another pregnancy nearly impossible.
"A specialist told me I would probably never be able to carry a second child," Kelly recalls.
Hoping for the best, Kelly joined a clinical trial being conducted exclusively at Memorial Sloan Kettering Cancer Center (MSK),), led by medical oncologist Andrea Cercek, MD, Section Head of Colorectal Cancer, and physician-scientist Luis Diaz Jr., MD, Head of the Division of Solid Tumor Oncology.
The goal of the trial was to help people like Kelly overcome rectal cancer while preserving their quality of life — using immunotherapy alone.
That would mean avoiding surgery, radiation, and chemotherapy, which can have life-altering consequences for people with rectal cancer. Instead, participants would have infusions of an immunotherapy agent every few weeks, while their tumors were closely monitored.
The trial was small, with 18 patients enrolled when results were announced in June 2022. Like Kelly, all the participants had a specific and quite rare genetic mutation in their tumor that made them eligible. This mutation — classified as mismatch repair-deficient, or MMR(d) — occurs in only about 5% to 10% of people diagnosed with rectal cancer.
The MSK team watched with growing excitement as one patient after another saw their tumor shrink, often so quickly that it even surprised the doctors involved.
The results of the trial were so astounding that they made headlines around the world when they were announced in June. All 18 people in the trial saw their rectal cancer disappear — every single patient, including Kelly. Experts say that kind of result has never been seen before in a cancer trial. Statistician James White, who works closely with MSK researchers, calculated the odds of such an outcome at a trillion to one.
The trial continues to enroll patients, and its success reached new heights when Kelly and John announced the birth of their daughter Mya Grace in July, 2023.
"She is my miracle baby," says Kelly, who welcomed Dr. Cercek to her home in southern New Jersey four days after Mya Grace's birth. "She's because of you," Kelly told Dr. Cercek.
Dr. Cercek visited Kelly and her family with a video crew from Stand Up To Cancer, who created a video about Kelly and the clinical trial for their nationally televised broadcast to raise money for innovative cancer research. Stand Up To Cancer contributed funding for this ground-breaking clinical trial.
"Holding her beautiful little girl was an experience that's almost beyond words," says Dr. Cercek." "I cried so many happy tears knowing the trial helped people exactly as we hoped it would."
Using Immunotherapy Alone To Treat Rectal Cancer
Dr. Andrea Cerck of MSK holding newborn Mya Grace, the daughter of Kelly Spill and John Bonito (Photo Credit: Stand Up To Cancer)
"The standard treatment for rectal cancer can work well," explains Dr. Cercek. "But surgery, radiation, and chemotherapy can be particularly hard on people with this cancer because of the location of the tumor. They can suffer life-altering bowel and bladder dysfunction, incontinence, sexual dysfunction, and infertility."
To avoid these awful side effects, Drs. Cercek and Diaz designed the clinical trial to investigate if the body's own immune system could be deployed to attack cancer cells, using a form of immunotherapy called a checkpoint inhibitor.
Previous work by Dr. Diaz had shown that checkpoint inhibitors are effective in targeting rectal tumors that harbor the genetic mutation MMR(d), which prevents tumor cells from fixing damaged DNA. Dr. Diaz explains: "We wanted to see if we could make a tumor with the MMR(d) mutation recede and eventually disappear using only immunotherapy to spare patients these life-altering consequences of standard treatment."
Request an Appointment Call 800-525-2225Available Monday through Friday, 8 a.M. To 6 p.M. (Eastern time) Life-Changing ResultsLike Kelly, the other patients enrolled in the trial hoped their cancer could be treated with immunotherapy alone.
Another trial patient, Avery Holmes, recalls: "It went from this terrifying experience of 'Am I going to die?' to 'Maybe I can get through this.' I can't imagine what my life would be like if this clinical trial wasn't available."
VIDEO01:56
Hear from the patients about the treatment they received. This approach helps the patients' own immune systems recognize and attack their tumors, which contain a vulnerable genetic mutation. This treatment allowed the patients to be treated without surgery, radiation, or chemotherapy.
Video DetailsSascha Roth was the first patient to join the clinical trial. "At a hospital at home in Washington, D.C., doctors wanted to start me on standard treatment, which would begin with chemotherapy," she says. "But I had also consulted the specialists at MSK. They told me standard treatment was not a good fit for me because I have Lynch syndrome — an inherited trait that often leads to colorectal cancer. As it turned out, I was a perfect candidate for this trial.
After her treatment at MSK, Sascha has no evidence of cancer more than two years later — a key milestone in treating rectal cancer. "My whole experience has been like a dream," she says. And she has seamlessly returned to her vibrant social life while running her family's home decor business.
The trial's promise also energized the MSK staff dedicated to the research. This large team included clinical trial nurse Jenna Sinopoli, MSN; clinical research supervisor Jill Weiss; medical oncologist Melissa Lumish, MD; the colorectal surgery team who carefully monitored the tumor responses; and many people who checked in patients, drew blood, ran tests, logged results, organized data, and more.
"One day, a young woman introduced herself to me at the elevator," recalls Dr. Cercek. "She said: 'I'm the person who runs the biopsies from clinic rooms into the lab to be tested. It's so amazing to be part of your study because everyone is so happy when the results come back and the tumor is gone — it's just so inspiring.' "
Expanding Access to More People With Rectal Cancer"The response to the trial has been overwhelming," says Dr. Diaz. "We nearly doubled the enrollment of patients in two months after the research was made public. There are now 29 rectal cancer patients in the trial — and more continue to enroll."
MSK is also expanding the trial to hospitals that are members of the MSK Cancer Alliance, including the Hartford HealthCare Cancer Institute in Connecticut, the Lehigh Valley Cancer Institute in Pennsylvania, the Miami Cancer Institute at Baptist Health South Florida, and MSK collaborator New York Cancer & Blood Specialists.
An FDA advisory committee in February 2023 authorized a larger clinical trial to be led by MSK involving multiple clinics. This would be a key step in gaining full FDA approval so the approach could be used for patients at other hospitals who are facing rectal cancer and have the MMR(d) mutation.
A Possible New Approach to Solid Tumors
Medical oncologist Luis Diaz Jr., MD, is co-leader of the rectal cancer clinical trial at MSK.
MSK is also using the success of the rectal cancer trial to expand this novel approach to more cancers.
Dr. Cercek explains: "The MMR(d) mutation that we targeted in the trial is only found in 5% to 10% of all rectal cancers. But the mutation is also found in solid tumors, including gastric (stomach), colon, liver, bladder, esophageal, prostate, pancreatic, and other cancers. That means we could potentially help a lot more people."
Drs. Cercek and Diaz and colleagues at MSK have opened new clinical trials to investigate the approach in other cancers — and are now enrolling patients. These trials are open for people whose tumors have the MMR(d) mutation in all cancer subtypes including of the colon, bladder, stomach, prostate, and liver.
Dr. Diaz, appointed by President Biden to the National Cancer Advisory Board, has coined a term for this new method — "immunoablative" therapy— which means using immunotherapy to replace surgery, chemotherapy, and radiation to remove cancer.
The new approach is also aimed at targets beyond MMR(d), including HER2, a gene that can produce too much of a protein that fuels cancer growth. That clinical trial, led by Dr. Cercek, is also open at MSK and enrolling patients. Says Dr. Diaz: "The rectal cancer clinical trial is just the tip of the iceberg."
Even people who understand that the new approach isn't going to help their loved ones are emailing Dr. Cercek. "People have reached out to say, 'My relative has advanced disease, and we know things are not going well. But thank you for giving us hope that something better will come in the future.' "
'A Whole Better Version of Me'Today, many of the patients who participated in the trial are helping others. In addition to caring for her two young children, Kelly makes time to counsel others diagnosed with rectal cancer. She says she has found a new perspective on life. "I'm not the same person that I was before cancer. I love who I am, and I love who I was. But this is a whole better version of me these days."
Sascha says one key takeaway of the experience for her is that it really does take MSK to make these kinds of breakthroughs. "MSK research and cancer care is simply years ahead of where other hospitals — even really good ones — are or should be."
How Many Of Trump's Trials Will Happen Before The Election?
Three different prosecutors want to put Donald J. Trump on trial in four different cities next year, all before Memorial Day and in the midst of his presidential campaign.
It will be nearly impossible to pull off.
A morass of delays, court backlogs and legal skirmishes awaits, interviews with nearly two dozen current and former prosecutors, judges, legal experts and people involved in the Trump cases show. Some experts predicted that only one or two trials will take place next year; one speculated that none of the four Trump cases will start before the election.
It would be virtually unheard of for any defendant to play a game of courthouse Twister like this, let alone one who is also the leading contender for the Republican nomination for the presidency. And between the extensive legal arguments that must take place before a trial can begin — not to mention that the trials themselves could last weeks — there are simply not enough boxes on the calendar to squeeze in all the former president's trials.
"This is something that is not normal," said Jeffrey Bellin, a former federal prosecutor in Washington who now teaches criminal procedure at William & Mary Law School and believes that Mr. Trump might only be on trial once next year. "While each of the cases seems at this point to be strong, there's only so much you can ask a defendant to do at one time."
Any delay would represent a victory for Mr. Trump, who denies all wrongdoing and who could exploit the timeline to undermine the cases against him. Less time sitting in a courtroom equals more time hitting the campaign trail, and his advisers have not tried to hide that Mr. Trump hopes to overcome his legal troubles by winning the presidency.
If his lawyers manage to drag out the trials into 2025 or beyond — potentially during a second Trump administration — Mr. Trump could seek to pardon himself or order his Justice Department to shut down the federal cases. And although he could not control the state prosecutions in Georgia or Manhattan, the Justice Department has long held that a sitting president cannot be criminally prosecuted, which very likely applies to state cases as well.
Ultimately, the judges overseeing the four cases might have to coordinate so that Mr. Trump's lawyers can adequately prepare his defense without needlessly delaying the trials. Judges are permitted under ethics rules to confer with one another to efficiently administer the business of their courts, experts said, and they periodically do so.
"The four indictments can appear to resemble four cars converging on an intersection that has no lights or stop signs — but that won't happen," said Stephen Gillers, a legal ethics professor at New York University School of Law. "Well before the intersection, the judges will figure it out."
For now, Mr. Trump's court schedule looks to be nearly as crowded as his campaign calendar, with potential trials overlapping with key dates in the Republican primary season. Claiming he is a victim of a weaponized justice system that is seeking to bar him from office, Mr. Trump may end up bringing his campaign to the courthouse steps.
A federal special counsel, Jack Smith, has proposed Jan. 2 of next year (two weeks before the Iowa caucuses) as a date for Mr. Trump to stand trial in Washington on charges of conspiring to overturn the 2020 election. In a Thursday night court filing, Mr. Trump's lawyers countered with a proposed date of April 2026.
Fani T. Willis, the Fulton County, Ga., district attorney who this week announced racketeering charges against Mr. Trump, accusing him of orchestrating a "criminal enterprise" to reverse Georgia's election results, wants that trial to begin on March 4 (the day before Super Tuesday).
Mr. Smith's recent case in Washington, and Ms. Willis's in Georgia, were filed after Mr. Trump was already scheduled for two additional criminal trials next spring: in New York, on March 25, on state charges related to a hush-money payment to the porn star Stormy Daniels; and in Florida, on May 20, on federal charges brought by Mr. Smith accusing Mr. Trump of mishandling classified material after leaving office.
Although the New York and Florida indictments were unveiled earlier, affording them first crack at the calendar, some experts now argue that they should take a back seat to the election-related cases, in Georgia and Washington, in which the charges strike at the core of American democracy. Trial scheduling is not always a first-come, first-served operation, and deference could be given to the most serious charges.
In a radio interview last month, the Manhattan district attorney, Alvin L. Bragg, said that having been the first to indict did not necessarily mean he would insist on being the first to put the former president on trial. However, he said, the judge in the case, Juan M. Merchan, ultimately controls the calendar.
"We will follow the court's lead," Mr. Bragg said.
There has not yet been any direct communication among judges or prosecutors about moving the Manhattan case, according to people with knowledge of the matter.
Still, Mr. Bragg's comments suggest that he would not oppose moving the Manhattan case, which carries a lesser potential punishment than the three others, backward in line.
"My own belief is Alvin Bragg will be true to his word and remain flexible in the interests of justice," said Norman Eisen, who worked for the House Judiciary Committee during Mr. Trump's first impeachment and believes that prosecutors might be able to squeeze in three Trump trials next year.
And Mr. Eisen, now a senior fellow at the Brookings Institution, argued that voters deserve to know whether Mr. Trump was convicted of subverting the will of the people in the previous election before they vote in the next one.
"There could not be a more important question confronting the country than whether a candidate for the office of the presidency is innocent or guilty of previously abusing that office in an attempted coup," he said.
The most likely candidate to take over Mr. Bragg's March trial date would be Mr. Smith and his election interference case. Recently, nearly a dozen Republican-appointed former judges and high-ranking federal officials submitted a brief to the judge overseeing that case, arguing that the trial should take place in January as Mr. Smith has proposed and citing a "national necessity" for a "fair and expeditious trial."
But this is the case in which Mr. Trump's lawyers have asked for a 2026 trial date, citing the voluminous amount of material turned over by the government — 11.5 million pages of documents, for example — that the defense must now review. Mr. Trump's lawyers estimated that to finish by the prosecution's proposed January trial date would mean reading the equivalent of "Tolstoy's 'War and Peace,' cover to cover, 78 times a day, every day, from now until jury selection."
In that case, Mr. Smith brought a narrow set of charges against Mr. Trump in connection with efforts to overturn the 2020 election, totaling four felony counts, and with no co-defendants.
In contrast, Ms. Willis's election case is a sweeping 98-page indictment of not only Mr. Trump, who faces 13 criminal counts, but also 18 co-defendants, including Mark Meadows, the former White House chief of staff, and Rudolph W. Giuliani, the former mayor of New York City. Already, Mr. Meadows has petitioned for his case to be moved from state to federal court, and other defendants are likely to follow suit. That process could take months and could be appealed to the U.S. Supreme Court, probably making Ms. Willis's proposed trial date of March 4 something of a long shot.
The sheer size of Mr. Trump's Georgia case, and the fact it was the last of the four cases to be brought, suggests any Georgia trial of Mr. Trump could be delayed even beyond next year.
It is exceedingly rare for a criminal defendant to face so many trials in such a concentrated period of time. The once high-flying lawyer Michael Avenatti seemed to be heading for three federal trials after he was charged in Manhattan in 2019 in a scheme to extort the apparel giant Nike; and, separately, with stealing money from Ms. Daniels, a former client; and in California, with embezzling money from other clients. (He was eventually convicted in the New York trials and pleaded guilty in the California case.)
E. Danya Perry, a lawyer who represented Mr. Avenatti in the Nike case, the first to go to trial, said the challenge was "sequencing the cases in a way that would be most advantageous" to her client. And because there was some overlap in the evidence, she said, the defense had to be careful not to open the door for prosecutors to introduce evidence against Mr. Avenatti from another of the cases.
"You're not just trying the case in front of that particular judge," Ms. Perry said. "Evidence from one case could bleed into other cases."
Before any trial, Mr. Trump's cases are also likely to become bogged down as his lawyers review and potentially argue over large amounts of documents and other case material turned over by the government. Certain judicial rulings could also lead to drawn-out pretrial appeals.
In the Florida documents case, disputes over the use of classified information could delay the proceeding as well. And in the federal court in Washington, which is already contending with lengthy backlogs amid prosecutions of hundreds of Jan. 6 rioters, Mr. Trump's lawyers have suggested they plan to litigate complex constitutional issues, including whether some of Mr. Trump's false claims about the election were protected by the First Amendment.
Even the jury selection process could drag on for weeks or months, as courts summon huge pools of prospective jurors for questioning over whether they harbor bias in favor of or against the polarizing former president.
Michael B. Mukasey, a former U.S. Attorney general and longtime Manhattan federal judge, said because of the complex issues raised in all four of Mr. Trump's cases, "I think the odds are slim to none that any of them gets to trial before the election."
And Mr. Trump's criminal cases are not the only courtroom battles he's waging.
In October, he faces trial in a civil suit filed by Attorney General Letitia James of New York, accusing him, his company and three of his children of a "staggering" fraud in overvaluing his assets by billions of dollars. In January, Mr. Trump faces two civil trials arising from private lawsuits: one a defamation claim by the writer E. Jean Carroll and the other accusing him of enticing people into a sham business opportunity.
"We fully expect both cases to go to trial in January 2024," said Roberta A. Kaplan, the plaintiffs' lawyer in the two private suits.
Although Mr. Trump need not be in court for the civil cases, he almost certainly will have to attend the criminal trials, said Daniel C. Richman, a former Manhattan federal prosecutor and now a professor at Columbia Law School.
"If you asked all the prosecutors in each case, they'd firmly and sincerely say that they want these trials to happen in the first half of 2024," Mr. Richman said. "But wishing does not make it so."
Maggie Haberman and Alan Feuer contributed reporting. Sheelagh McNeill contributed research.
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