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One way to speed up clinical trials: Skip right to the data with electronic medical records

In health care crises, researchers can avoid waiting for clinical trial results by using data from health care systems to analyze the effectiveness of…

It takes around 17 years for medical research to translate into clinical practice. shapecharge/E+ via Getty Images

Scientific knowledge, as measured by numbers of papers published, has been estimated to double every 17.3 years. However, it takes an average of about 17 years for health and medical research – going from basic lab studies on cell cultures and animals to clinical trials in people – to result in actual changes patients see in the clinic.

The typical process of medical research is generally not well equipped to respond effectively to quickly evolving pandemics. This has been especially evident for the COVID-19 pandemic, in part because the virus the causes COVID-19 mutates frequently. Scientists and public health officials are often left continually scrambling to develop and test new treatments to match emerging variants.

Fortunately, scientists may be able to bypass the typical research timeline and study treatments and interventions as they are used in the clinic nearly in real time by leveraging a common source of existing data – electronic medical records, or EMRs.

We are a team composed of an epidemiologist, pharmacist and cardiologist at the University of Pittsburgh Medical Center. During the COVID-19 pandemic, we realized the need to quickly study and disseminate accurate information on the most effective treatment approaches, especially for patients at high risk of hospitalization and death. In our recently published research, we used EMR data to show that early treatment with one or more of five different monoclonal antibodies substantially reduced the risk of hospitalization or death compared with delayed or no treatment.

Two surgeons reviewing medical records in front of computer screens
EMRs contain a wealth of clinical data that could be used for research. Reza Estakhrian/The Image Bank via Getty Images

Using EMR data for research

In the U.S., health care systems typically use EMR systems for documenting patient care and for administrative purposes like billing. While data collection is not uniform, these systems typically contain detailed records that can include sociodemographic information, medical history, test results, surgical and other procedures, prescriptions and billing charges.

Unlike single-payer health care systems that integrate data into a single EMR system, such as in the U.K. and in Scandinavian countries, many large health care systems in the U.S. collect patient data using multiple EMR systems.

Having multiple EMR systems adds a layer of complexity to using such data to conduct scientific research. To address this, the University of Pittsburgh Medical Center developed and maintains a clinical data warehouse that compiles and harmonizes data across the seven different EMR systems its 40 hospitals and outpatient clinics use.

Emulating clinical trials

Using EMR data for research is not new. More recently, researchers have been looking into ways to use these large health data systems to emulate randomized controlled trials, which are considered the gold standard study design yet are often costly and take years to complete.

Using this emulation framework, our team used the EMR data infrastructure at our institution to evaluate five different monoclonal antibodies for which the Food and Drug Administration granted emergency use authorization to treat COVID-19. Monoclonal antibodies are human-made proteins designed to prevent a pathogen – in this case the virus that causes COVID-19 – from entering human cells, replicating and causing serious illness. Initially the authorizations were based on clinical trial data. But as the virus mutated, subsequent evaluations based on cell culture studies suggested a loss of effectiveness.

Close-up of health care provider accessing medical record on tablet
EMR data could be used to confirm that the results of cell culture studies would apply in the clinic. Solskin/DigitalVision via Getty Images

We wanted to confirm that the findings of cell-based studies applied to actual patients. So we evaluated anonymous clinical data from 2,571 patients treated with these monoclonal antibodies within two days of COVID-19 infection, matching them with data from 5,135 patients with COVID-19 who were eligible for but either did not receive these treatments or received them three or more days after infection.

We found that overall, people who received monoclonal antibodies within two days of a positive COVID-19 test reduced their risk of hospitalization or death by 39% compared with those who did not receive the treatment or received delayed treatment. In addition, patients with compromised immune systems reduced their risk of hospitalization or death by 55%, regardless of their age.

Our near-real-time analysis of COVID-19 patients treated with monoclonal antibodies during the pandemic confirmed the findings of the cell culture studies. Our findings suggest that by using data in this way, researchers may be able to evaluate treatments in times of urgency without having to perform clinical trials.

Appropriate EMR data use

Many health care institutions have EMR systems that researchers can harness to rapidly answer important research questions as they arise. However, because this clinical data is not specifically collected for research purposes, researchers need to carefully design their studies and use rigorous data validation and analysis. They also need to take great care to harmonize data from different EMR systems, select appropriate patient samples and minimize all sources of potential bias.

New pandemics and significant public health challenges are likely to emerge abruptly and in unpredictable ways. Given the treasure trove of data routinely collected across U.S. health care systems, we believe that careful use of these data can help answer urgent health questions in ways that are representative of who’s actually receiving care.

Erin McCreary has served on scientific advisory boards for Shionogi, Inc and Merck.

Kevin Kip and Oscar Marroquin do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

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Government

Angry Shouting Aside, Here’s What Biden Is Running On

Angry Shouting Aside, Here’s What Biden Is Running On

Last night, Joe Biden gave an extremely dark, threatening, angry State of the Union…

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Angry Shouting Aside, Here's What Biden Is Running On

Last night, Joe Biden gave an extremely dark, threatening, angry State of the Union address - in which he insisted that the American economy is doing better than ever, blamed inflation on 'corporate greed,' and warned that Donald Trump poses an existential threat to the republic.

But in between the angry rhetoric, he also laid out his 2024 election platform - for which additional details will be released on March 11, when the White House sends its proposed budget to Congress.

To that end, Goldman Sachs' Alec Phillips and Tim Krupa have summarized the key points:

Taxes

While railing against billionaires (nothing new there), Biden repeated the claim that anyone making under $400,000 per year won't see an increase in their taxes.  He also proposed a 21% corporate minimum tax, up from 15% on book income outlined in the Inflation Reduction Act (IRA), as well as raising the corporate tax rate from 21% to 28% (which would promptly be passed along to consumers in the form of more inflation). Goldman notes that "Congress is unlikely to consider any of these proposals this year, they would only come into play in a second Biden term, if Democrats also won House and Senate majorities."

Biden also called on Congress to restore the pandemic-era child tax credit.

Immigration

Instead of simply passing a slew of border security Executive Orders like the Trump ones he shredded on day one, Biden repeated the lie that Congress 'needs to act' before he can (translation: send money to Ukraine or the US border will continue to be a sieve).

As immigration comes into even greater focus heading into the election, we continue to expect the Administration to tighten policy (e.g., immigration has surged 20pp the last 7 months to first place with 28% in Gallup’s “most important problem” survey). As such, we estimate the foreign-born contribution to monthly labor force growth will moderate from 110k/month in 2023 to around 70-90k/month in 2024. -GS

Ukraine

Biden, with House Speaker Mike Johnson doing his best impression of a bobble-head, urged Congress to pass additional assistance for Ukraine based entirely on the premise that Russia 'won't stop' there (and would what, trigger article 5 and WW3 no matter what?), despite the fact that Putin explicitly told Tucker Carlson he has no further ambitions, and in fact seeks a settlement.

As Goldman estimates, "While there is still a clear chance that such a deal could come together, for now there is no clear path forward for Ukraine aid in Congress."

China

Biden, forgetting about all the aggressive tariffs, suggested that Trump had been soft on China, and that he will stand up "against China's unfair economic practices" and "for peace and stability across the Taiwan Strait."

Healthcare

Lastly, Biden proposed to expand drug price negotiations to 50 additional drugs each year (an increase from 20 outlined in the IRA), which Goldman said would likely require bipartisan support "even if Democrats controlled Congress and the White House," as such policies would likely be ineligible for the budget "reconciliation" process which has been used in previous years to pass the IRA and other major fiscal party when Congressional margins are just too thin.

So there you have it. With no actual accomplishments to speak of, Biden can only attack Trump, lie, and make empty promises.

Tyler Durden Fri, 03/08/2024 - 18:00

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Government

Jack Smith Says Trump Retention Of Documents “Starkly Different” From Biden

Jack Smith Says Trump Retention Of Documents "Starkly Different" From Biden

Authored by Catherine Yang via The Epoch Times (emphasis ours),

Special…

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Jack Smith Says Trump Retention Of Documents "Starkly Different" From Biden

Authored by Catherine Yang via The Epoch Times (emphasis ours),

Special counsel Jack Smith has argued the case he is prosecuting against former President Donald Trump for allegedly mishandling classified information is “starkly different” from the case the Department of Justice declined to bring against President Joe Biden over retention of classified documents.

(Left) Special counsel Jack Smith in Washington on Aug. 1, 2023. (Drew Angerer/Getty Images); (Right) Former President Donald Trump. (David Dee Delgado/Getty Images)

Prosecutors, in responding to a motion President Trump filed to dismiss the case based on selective and vindictive prosecution, said on Thursday this is not the case of “two men ‘commit[ting] the same basic crime in substantially the same manner.”

They argue the similarities are only “superficial,” and that there are two main differences: that President Trump allegedly “engaged in extensive and repeated efforts to obstruct justice and thwart the return of documents” and the “evidence concerning the two men’s intent.”

Special counsel Robert Hur’s report found that there was evidence that President Biden “willfully” retained classified Afghanistan documents, but that evidence “fell short” of concluding guilt of willful retention beyond reasonable doubt.

Prosecutors argue the “strength of the evidence” is a crucial element showing these cases are not “similarly situated.”

Trump may dispute the Hur Report’s conclusions but he should not be allowed to misrepresent them,” prosecutors wrote, arguing that the defense’s argument to dismiss the case fell short of legal standards.

They point to volume as another distinction: President Biden had 88 classified documents and President Trump had 337. Prosecutors also argued that while President Biden’s Delaware garage “was plainly an unsecured location ... whatever risks are posed by storing documents in a private garage” were “dwarfed” by President Trump storing documents at an “active social club” with 150 staff members and hundreds of visitors.

Defense attorneys had also cited a New York Times report where President Biden was reported to have held the view that President Trump should be prosecuted, expressing concern about his retention of documents at Mar-a-lago.

Prosecutors argued that this case was not “foisted” upon the special counsel, who had not been appointed at the time of these comments.

“Trump appears to contend that it was President Biden who actually made the decision to seek the charges in this case; that Biden did so solely for unconstitutional reasons,” the filing reads. “He presents no evidence whatsoever to show that Biden’s comments about him had any bearing on the Special Counsel’s decision to seek charges, much less that the Special Counsel is a ’stalking horse.'”

8 Other Cases

President Trump has argued he is being subjected to selective and vindictive prosecution, warranting dismissal of the case, but prosecutors argue that the defense has not “identified anyone who has engaged in a remotely similar battery of criminal conduct and not been prosecuted as a result.”

In addition to President Biden, defense attorneys offered eight other examples.

Former Vice President Mike Pence had, after 2023 reports about President Biden retaining classified documents surfaced, retained legal counsel to search his home for classified documents. Some documents were found, and he sent them to the National Archives and Records Administration (NARA).

Prosecutors say this was different from President Trump’s situation, as Vice President Pence returned the documents out of his own initiative and had fewer than 15 classified documents.

Former President Bill Clinton had retained a historian to put together “The Clinton Tapes” project, and it was later reported that NARA did not have those tapes years after his presidency. A court had ruled it could not compel NARA to try to recover the records, and NARA had defined the tapes as personal records.

Prosecutors argue those were tape diaries and the situation was “far different” from President Trump’s.

Former Secretary of State Hillary Clinton had “used private email servers ... to conduct official State Department business,” the DOJ found, and the FBI opened a criminal investigation.

Prosecutors argued this was a different situation where the secretary’s emails showed no “classified” markings and the deletion of more than 31,000 emails was done by an employee and not the secretary.

Former FBI Director James Comey had retained four memos “believing that they contained no classified information.” These memos were part of seven he authored addressing interactions he had with President Trump.

Prosecutors argued there was no obstructive behavior here.

Former CIA Director David Petraeus kept bound notebooks that contained classified and unclassified notes, which he allowed a biographer to review. The FBI later seized the notebooks and Mr. Petraeus took a guilty plea.

Prosecutors argued there was prosecution in Mr. Petraeus’s case, and so President Trump’s case is not selective.

Former national security adviser Sandy Berger removed five copies of a classified document and kept them at his personal office, later shredding three of the copies. When confronted by NARA, he returned the remaining two copies and took a guilty plea.

Former CIA director John Deutch kept a journal with classified information on an unclassified computer, and also took a guilty plea.

Prosecutors argued both Mr. Berger and Mr. Deutch’s behavior was “vastly less egregious than Trump’s” and they had been prosecuted.

Former White House coronavirus response coordinator Deborah Birx had possession of classified materials according to documents retrieved by NARA.

Prosecutors argued that there was no indication she knew she had classified information or “attempted to obstruct justice.”

Tyler Durden Fri, 03/08/2024 - 17:40

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International

United Airlines adds new flights to faraway destinations

The airline said that it has been working hard to "find hidden gem destinations."

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Since countries started opening up after the pandemic in 2021 and 2022, airlines have been seeing demand soar not just for major global cities and popular routes but also for farther-away destinations.

Numerous reports, including a recent TripAdvisor survey of trending destinations, showed that there has been a rise in U.S. traveler interest in Asian countries such as Japan, South Korea and Vietnam as well as growing tourism traction in off-the-beaten-path European countries such as Slovenia, Estonia and Montenegro.

Related: 'No more flying for you': Travel agency sounds alarm over risk of 'carbon passports'

As a result, airlines have been looking at their networks to include more faraway destinations as well as smaller cities that are growing increasingly popular with tourists and may not be served by their competitors.

The Philippines has been popular among tourists in recent years.

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United brings back more routes, says it is committed to 'finding hidden gems'

This week, United Airlines  (UAL)  announced that it will be launching a new route from Newark Liberty International Airport (EWR) to Morocco's Marrakesh. While it is only the country's fourth-largest city, Marrakesh is a particularly popular place for tourists to seek out the sights and experiences that many associate with the country — colorful souks, gardens with ornate architecture and mosques from the Moorish period.

More Travel:

"We have consistently been ahead of the curve in finding hidden gem destinations for our customers to explore and remain committed to providing the most unique slate of travel options for their adventures abroad," United's SVP of Global Network Planning Patrick Quayle, said in a press statement.

The new route will launch on Oct. 24 and take place three times a week on a Boeing 767-300ER  (BA)  plane that is equipped with 46 Polaris business class and 22 Premium Plus seats. The plane choice was a way to reach a luxury customer customer looking to start their holiday in Marrakesh in the plane.

Along with the new Morocco route, United is also launching a flight between Houston (IAH) and Colombia's Medellín on Oct. 27 as well as a route between Tokyo and Cebu in the Philippines on July 31 — the latter is known as a "fifth freedom" flight in which the airline flies to the larger hub from the mainland U.S. and then goes on to smaller Asian city popular with tourists after some travelers get off (and others get on) in Tokyo.

United's network expansion includes new 'fifth freedom' flight

In the fall of 2023, United became the first U.S. airline to fly to the Philippines with a new Manila-San Francisco flight. It has expanded its service to Asia from different U.S. cities earlier last year. Cebu has been on its radar amid growing tourist interest in the region known for marine parks, rainforests and Spanish-style architecture.

With the summer coming up, United also announced that it plans to run its current flights to Hong Kong, Seoul, and Portugal's Porto more frequently at different points of the week and reach four weekly flights between Los Angeles and Shanghai by August 29.

"This is your normal, exciting network planning team back in action," Quayle told travel website The Points Guy of the airline's plans for the new routes.

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