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• Published: 23 December 2022

11 clinical trials that will shape medicine in 2023

• Carrie Arnold 1 &
• Paul Webster 2  

Nature Medicine volume  28 ,  pages 2444–2448 ( 2022 ) Cite this article

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An Author Correction to this article was published on 27 February 2023

This article has been updated

Nature Medicine asks leading researchers to name their top clinical trial for 2023, from cervical and prostate cancer screening to new drugs for Parkinson’s disease and Alzheimer’s disease.

2022 has been a rollercoaster year for biopharma, as it has faced an industry-wide slowdown and late-stage clinical trial failures, as well as breakthroughs and regulatory approvals.

COVID-19 has continued to disrupt nearly all aspects of clinical trial infrastructure, from patient recruitment to supply chains, but despite this, 2023 promises to bring many new readouts from different branches of medicine (Table 1 ).

We asked 11 leading experts for their top clinical trials to watch in the coming year.

A diabetes drug for Parkinson’s disease

Roger Albin: For both purely scientific issues and clinical practice issues, the phase 3 trial for exenatide in Parkinson’s disease is a very attractive trial. It has the big advantage of being a repurposed drug that is already widely used in older patients. If there were a positive result, it is something that could be really adopted into clinical practice in a very practical way. The drug had reasonable preclinical data and some promising phase 2 data, and in the Parkinson’s disease world, in which there is not an animal model for really great predictive validity, this is probably about as good as it gets. The community is looking for unequivocal results, whether positive or negative. A clear positive response would be great, but a clear negative response is actually just as important.

Roger Albin is a professor of neurology and co-director of the Movement Disorders Clinic in the Department of Neurology at the University of Michigan Medical School .

ADC for ovarian cancer

Robert L. Coleman: The most imminent and important upcoming trial result expected in my field in 2023 is mirvetuximab soravtansine, from ImmunoGen. This received accelerated approval from the US Food and Drug Administration (FDA) on 14 November, based on results of a single-arm trial that enrolled 106 patients with platinum-resistant ovarian cancer whose tumors had high expression of folate receptor-α and who had been treated with up to three prior regimens, at least one of which included bevacizumab (Avastin).

Under accelerated approval, the sponsor can market their drug under the indication agreed to by the FDA — in this case, patients with recurrent, platinum-resistant ovarian cancer. For the drug to move from accelerated approval to regular approval, a confirmatory trial needs to be conducted to confirm the overall safety and efficacy of the agent of interest. In this case, initial results for the confirmatory phase 3 MIRASOL trial are expected in early 2023.

This drug is an antibody–drug conjugate (ADC); these agents are already being used for the treatment of several solid and liquid tumors, but this is the first for ovarian cancer. It will be aligned with a companion diagnostic test that mirrors the expression in tumors needed for clinical trial eligibility. We expect about one-third of patients with recurrent, platinum-resistant ovarian cancer to have high expression of folate receptor-α. The ADC field is expanding rapidly, with trastuzumab deruxtecan approved in April 2022 for use against breast cancer, but it has been a long time since a new cytotoxic agent has been approved for ovarian cancer. Among treatments for gynecological cancers, this is only the second ADC approved so far, after Tisotumab vedotin (in September 2021) for patients with recurrent previously treated cervical cancer. Now we have one in ovarian cancer. Several other ADCs are in development, and successful approval will provide a solid framework for clinical trials evaluating novel combinations in several disease settings.

Robert L. Coleman is chief scientific officer at US Oncology Research .

CRISPR–Cas9 for muscular dystrophy

Simone Spuler: Muscle stem cells are the only cells that can regenerate muscle. In patients who have a genetic muscular dystrophy in which muscle wastes for genetic reasons, these stem cells carry mutations, but these mutations can now be corrected with CRISPR–Cas9 and other tools. Correcting muscle stem cells means muscle can be rebuilt, which was not been previously possible whatsoever in these muscular dystrophies.

Muscular dystrophies are a group of about 50 different diseases that lead young people and children to lose their ability to walk, or to breathe, and make them wheelchair-bound within a couple of years. We are working with corrected muscle stem cells able to rebuild muscles and we will test this in a trial called bASKet. In the bASKet trial , there are two major questions. The first is about safety. We would like to see that nothing happens to the patients that makes the disease worse, such as a gene encoding a tumor suppressor being switched on. We do all kinds of preclinical safety tests to preclude that possibility. New proteins will be made by these stem cells, which probably have not been seen by the patient’s immune system, so it could attack this foreign protein. We will inject the cells that are repaired into the patient in an autologous manner, and check a few months later to see if new muscle is built. The second question we are addressing is about clinical improvement. This is something the regulatory agencies asked us to do. We hope to have the first data a few months after we begin treating patients in June and July 2023.

Simone Spuler leads the myology research group and the Outpatient Clinic for Muscle Disorders at the Experimental and Clinical Research Center, a joint institution established by the Max Delbrück Center and the Charité–Universitätsmedizin, in Berlin, Germany .

Cervical cancer screening in the vaccinated

Karen Canfell: Prophylactic vaccines against human papilloma virus (HPV), first rolled out 15 years ago, protect women against cervical cancer and are now routinely offered to young girls in most high-income countries. As time moves on, more women who were vaccinated as girls become eligible for cervical cancer screening, and it is important to understand the most effective screening approaches in a vaccinated population. This trial is important, as it is the first large-scale randomized controlled trial internationally that will assess primary HPV screening in a population that is heavily vaccinated against HPV. The findings from the secondary randomization will assess newer approaches for managing HPV-positive women, which will be important for cervical screening programs that are transitioning to primary HPV testing. The COMPASS trial is also assessing new next-generation HPV testing platforms and technologies for triage testing, which are expected to improve the overall performance of HPV testing at a program level.

Karen Canfell is chair of the Cancer Screening and Immunisation Committee of Cancer Council Australia .

The Mediterranean diet for weight loss

Jordi Salas Salvadó: No study has ever demonstrated that weight loss and maintenance using an energy-reduced healthy diet and physical activity lowers the risk of cardiovascular disease in people who are overweight or who have obesity. The Look AHEAD trial in the USA, conducted in people with diabetes, has been discontinued owing to lack of efficacy in reducing the risk of cardiovascular events and mortality after approximately 10 years of follow-up, despite achieving significant differences between interventions in long-term weight loss.

We hypothesize that an intensive lifestyle-intervention program aimed at weight loss and based on the traditional Mediterranean diet is a sustainable long-term approach for achieving weight loss in overweight and obese adults, and that the lifestyle changes achieved will have a beneficial effect on cardiovascular morbidity and mortality.

Jordi Salas Salvadó is a Distinguished Professor of Nutrition at Rovira i Virgili University and Principal Investigator at CIBER-Obn Instituto de Salud Carlos III, Spain .

Safe treatment for sleeping sickness

Olaf Valverde: In 2023, we will receive the complete results of our clinical trial testing of a breakthrough, all-oral, safe medicine for treating the variant of sleeping sickness caused by Trypanosoma brucei rhodesiense . Also known as human African trypanosomiasis, this neglected parasitic disease transmitted by the bite of the tse tse fly causes severe neuropsychiatric disorders. In contrast to T. brucei gambiense , for which humans are considered the primary reservoir, T. brucei rhodesiense is highly zoonotic, with animals and livestock considered the primary reservoir. It is endemic in eastern and southern Africa, evolves quickly, and can kill in weeks to months if left untreated.

For decades, doctors in endemic countries had to treat sleeping sickness by using melarsoprol, an arsenic derivative so toxic that it killed 5% of patients. Our organization started developing a series of improved drugs, and in 2018 registered fexinidazole, a safe and effective first all-oral drug for the variant of the disease caused by T. brucei gambiense . But for patients with the variant caused by T. brucei rhodesiense , doctors still have to use the dreaded melarsoprol for advanced cases. This clinical trial is assessing the efficacy of fexinidazole for sleeping sickness caused by T. brucei rhodesiense , in comparison with the efficacy of the existing drugs melarsoprol and suramin. Full results will be presented to the European Medicines Agency in 2023, and we expect to get a favorable opinion.

Olaf Valverde is the clinical project leader of the human African trypanosomiasis team of the Drugs for Neglected Diseases initiative .

Circulating tumor cells

Nicola Aceto: My lab is interested in metastasis. More than 90% of people with cancer die when metastasis happens. It is a big unsolved problem. We recently found that metastasis is driven mostly by clusters of circulating tumor cells (CTCs), which are multicellular aggregates of tumor cells that depart from the existing tumor , circulate in the bloodstream , and then metastasize. This finding challenged the prevailing dogma in the metastasis field, as until a few years ago, people thought metastasis happened one cell at a time. Thanks to new technologies, we could finally investigate blood samples from patients and in animal models, which allowed us to identify CTC clusters.

We have also found that there are drugs, such as digoxin, that have the ability to dissociate these cells and dissolve the clusters, which shuts down metastasis in preclinical models. We have now set up a small phase 1 trial as a proof of mechanism. We screen the blood of patients with advanced metastatic breast cancer, and when we find CTC clusters, we give the patients the drug for 3 weeks, during which time we measure the abundance and features of the clusters. Digoxin is a well-known drug used to treat heart conditions, but it has this beautiful side effect. Should the trial be successful, we envision the generation of improved cluster-dissociating molecules, able to achieve full cluster dissolution and specifically designed to treat cancer. This is the next ambitious goal: enabling a novel cancer-treatment modality that is aimed at blocking the spread of cancer.

Nicola Aceto is an associate professor of molecular oncology at ETH Zurich .

Lecanemab for Alzheimer’s disease

Allan Levey: In 2023, I expect to see more peer-reviewed publications and data on lecanemab, an investigational monoclonal antibody to amyloid-β protofibrils, for the treatment of mild cognitive impairment with Alzheimer’s disease. The developer, Eisai, announced positive topline results from their large global phase 3 confirmatory Clarity AD clinical trial of lecanemab in late September. We saw extensive data on lecanemab at the Clinical Trials on Alzheimer’s Congress in late November and early December 2022 and a landmark publication in the New England Journal of Medicine was published on 29 November 2022.

Much data have been made available for scrutiny and independent, secondary analyses with the publication. Eisai is expected to file an application with the FDA for traditional approval in the USA and marketing-authorization applications in Japan and Europe by the end of March 2023. This is a pivotal phase 3 trial that most experts consider a huge game-changer for this field. In Alzheimer’s disease, there are no disease-modifying treatments that are clearly proven (aducanumab has been approved, despite uncertain clinical efficacy). Until recently, evidence for disease modification has been lacking, despite an industry-wide focus on amyloid-based therapies for many years.

With this new lecanemab study, the results of the phase 3 study show a significant reduction in clinical progression, confirming the results of an earlier phase 2 study. All primary and secondary endpoints, including dementia severity, cognition and functional abilities, were met. The second issue is that safety has been a huge concern with previous treatments given accelerated approval. The results for lecanemab indicate that its safety is much better, although there were adverse events. These are the reasons it is a game changer. Additional important insights will be gleaned about the magnitude and duration of benefits, and a more palatable and scalable form of subcutaneous dosing when more data and analysis are published in 2023.

Allan Levey is a professor and chair of the Department of Neurology at Emory University’s School of Medicine, and director of the Emory University Goizueta Alzheimer’s Disease Research Center .

COVID-19 vaccination and HIV

Glenda Gray: In December 2021, we began a trial to enroll almost 14,500 participants in more than 50 research clinics in eight sub-Saharan African countries. The Ubuntu multicenter phase 3 clinical trial will assess the efficacy of the mRNA-1273 (Moderna) vaccine against COVID-19 in adults infected with human immunodeficiency virus (HIV) or with other comorbidities that increase the risk of severe COVID-19. This trial will include a smaller number of HIV-negative people.

There is an urgent need to characterize infection and viral clearance in people who are immunocompromised, which will be assessed in our study . The results, which we expect in 2023, should indicate how many doses of vaccine are needed for adults living with HIV, as well as in adults with other health conditions that may put them at risk for severe COVID-19. We are also expecting data on whether people who have been infected with the coronavirus SARS-CoV-2, and therefore probably have some immunity, need as many vaccine doses as those without prior infection. We also want to know if the original Moderna vaccine is inferior to the new bivalent one, which includes the spike protein from a SARS-CoV-2 variant of concern. This direct comparison of mRNA-1273 against the bivalent vaccine should give us insight into the utility of variant-specific vaccines. We hope that when these results are published next year, they will help to refine an optimal vaccine strategy and the best regimen for HIV-infected people.

Glenda Gray is president and CEO of the South Africa Medical Research Council .

Gene editing for sickle-cell disease

Luigi Naldini: We are all waiting for the first long-term data from gene-editing strategies in sickle-cell disease and thalassemia. There have been preliminary reports of efficient editing . The key question is whether these gene grafts remain stable. We have seen very safe stable long-term grafts of stem cells treated with lentiviral vectors, and prolonged safety, but will this be the same for gene-editing tools?

We may soon be seeing the interim results in 2023 of a multi-center sickle-cell disease trial of gene editing sponsored by CRISPR Therapeutics and Vertex Pharmaceuticals. This is a single-arm, open-label, multi-site, single-dose phase 1/2/3 study in people with severe sickle-cell disease. The study is evaluating the safety and efficacy of autologous CRISPR–Cas9-modified CD34 + human hematopoietic stem and progenitor cells. Participants receive a single infusion of these cells through a central venous catheter. The top outcome of interest would be participants who have not experienced any severe vaso-occlusive crisis for at least 12 consecutive months. It will be crucial to verify the long-term stability and polyclonal composition of the graft without the emergence of adverse events. Beyond this, what we are looking forward to seeing is the first clinical testing of what we call ‘writing back’ genes; that is, correcting genetic mutations by introducing editing of longer sequences, which has not been clinically achieved yet. We and others are actively working closely on that.

Luigi Naldini is a professor of cell and tissue biology and of gene and cell therapy at the San Raffaele University School of Medicine, and scientific director of the San Raffaele Telethon Institute for Gene Therapy, Milan, Italy .

Reducing harm from prostate cancer screening

Anssi Auvinen: The evidence surrounding testing for the marker PSA (prostate-specific antigen) is full of conflict, as the test may detect prostate cancer but at the expense of treating cancers with little threat to health. We aim to detect only clinically relevant, aggressive prostate cancer while minimizing the diagnosis of clinically unimportant, low-risk cancers that would constitute over-diagnosis (meaning that they would not progress even if left undetected and untreated). A previous trial showed benefits that were comparable to those of other cancer screening programs, but we wanted to put more effort into harnessing recent developments to reduce harm, including over-diagnosis and unnecessary biopsies.

Anssi Auvinen is a professor of health sciences at Tampere University, Finland .

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Arnold, C., Webster, P. 11 clinical trials that will shape medicine in 2023. Nat Med 28 , 2444–2448 (2022). https://doi.org/10.1038/s41591-022-02132-3

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In recommendations for the Department of Health and Human Services, the agenda calls for the Food and Drug Administration to reverse its 24-year-old approval of the widely used abortion pill mifepristone. Other proposed actions targeting medication abortion include reinstating more stringent rules for mifepristone's use, which would permit it to be taken up to seven weeks into a pregnancy, instead of the current 10 weeks, and requiring it to be dispensed in-person instead of through the mail.

The Alliance Defending Freedom, a conservative legal group that is on the Project 2025 advisory board, was involved in a legal challenge to mifepristone's 2000 approval and more recent actions from the FDA that made it easier to obtain. But the Supreme Court rejected the case brought by a group of anti-abortion rights doctors and medical associations on procedural grounds.

The policy book also recommends the Justice Department enforce the Comstock Act against providers and distributors of abortion pills. That 1873 law prohibits drugs, medicines or instruments used in abortions from being sent through the mail.

Now that the Supreme Court has overturned Roe v. Wade , the volume states that the Justice Department "in the next conservative administration should therefore announce its intent to enforce federal law against providers and distributors of such pills."

The guide recommends the next secretary of Health and Human Services get rid of the Reproductive Healthcare Access Task Force established by the Biden administration before Roe's reversal and create a "pro-life task force to ensure that all of the department's divisions seek to use their authority to promote the life and health of women and their unborn children."

In a section titled "The Family Agenda," the proposal recommends the Health and Human Services chief "proudly state that men and women are biological realities," and that "married men and women are the ideal, natural family structure because all children have a right to be raised by the men and women who conceived them."

Further, a program within the Health and Human Services Department should "maintain a biblically based, social science-reinforced definition of marriage and family."

During his first four years in office, Trump banned transgender people from serving in the military. Mr. Biden reversed that policy , but the Project 2025 policy book calls for the ban to be reinstated.

Targeting federal agencies, employees and policies

The agenda takes aim at longstanding federal agencies, like the National Oceanic and Atmospheric Administration, or NOAA. The agency is a component of the Commerce Department and the policy guide calls for it to be downsized. 

NOAA's six offices, including the National Weather Service and National Marine Fisheries Service, "form a colossal operation that has become one of the main drivers of the climate change alarm industry and, as such, is harmful to future U.S. prosperity," the guide states. 

The Department of Homeland Security, established in 2002, should be dismantled and its agencies either combined with others, or moved under the purview of other departments altogether, the policy book states. For example, immigration-related entities from the Departments of Homeland Security, Justice and Health and Human Services should form a standalone, Cabinet-level border and immigration agency staffed by more than 100,000 employees, according to the agenda.

If the policy recommendations are implemented, another federal agency that could come under the knife by the next administration, with action from Congress, is the Consumer Financial Protection Bureau.

The agenda seeks to bring a push by conservatives to target diversity, equity and inclusion, or DEI, initiatives in higher education to the executive branch by wiping away a slew of DEI-related positions, policies and programs and calling for the elimination of funding for partners that promote DEI practices.

It states that U.S. Agency for International Development staff and grantees that "engage in ideological agitation on behalf of the DEI agenda" should be terminated. At the Treasury Department, the guide says the next administration should "treat the participation in any critical race theory or DEI initiative without objecting on constitutional or moral grounds, as per se grounds for termination of employment."

The Project 2025 policy book also takes aim at more innocuous functions of government. It calls for the next presidential administration to eliminate or reform the dietary guidelines that have been published by the Department of Agriculture for more than 40 years, which the authors claim have been "infiltrated" by issues like climate change and sustainability.

Immigration

Trump made immigration a cornerstone of his last two presidential runs and has continued to hammer the issue during his 2024 campaign. Project 2025's agenda not only recommends finishing the wall along the U.S.-Mexico border, but urges the next administration to "take a creative and aggressive approach" to responding to drug cartels at the border. This approach includes using active-duty military personnel and the National Guard to help with arrest operations along the southern border.

A memo from Immigration and Customs Enforcement that prohibits enforcement actions from taking place at "sensitive" places like schools, playgrounds and churches should be rolled back, the policy guide states. 

When the Homeland Security secretary determines there is an "actual or anticipated mass migration of aliens" that presents "urgent circumstances" warranting a federal response, the agenda says the secretary can make rules and regulations, including through their expulsion, for as long as necessary. These rules, the guide states, aren't subject to the Administration Procedure Act, which governs the agency rule-making process.

What do Trump and his advisers say about Project 2025?

In a post to his social media platform on July 5, Trump wrote , "I know nothing about Project 2025. I have no idea who is behind it. I disagree with some of the things they're saying and some of the things they're saying are absolutely ridiculous and abysmal. Anything they do, I wish them luck, but I have nothing to do with them."

Trump's pushback to the initiative came after Heritage Foundation President Kevin Roberts said in a podcast interview that the nation is "in the process of the second American Revolution, which will remain bloodless if the left allows it to be."

The former president continued to disavow the initiative this week, writing in another social media post  that he knows nothing about Project 2025.

"I have not seen it, have no idea who is in charge of it, and, unlike our very well received Republican Platform, had nothing to do with it," Trump wrote. "The Radical Left Democrats are having a field day, however, trying to hook me into whatever policies are stated or said. It is pure disinformation on their part. By now, after all of these years, everyone knows where I stand on EVERYTHING!"

While the former president said he doesn't know who is in charge of the initiative, the project's director, Dans, and associate director, Chretien, were high-ranking officials in his administration. Additionally, Ben Carson, former secretary of Housing and Urban Development under Trump; John Ratcliffe, former director of National Intelligence in the Trump administration; and Peter Navarro, who served as a top trade adviser to Trump in the White House, are listed as either authors or contributors to the policy agenda.

Still, even before Roberts' comments during "The War Room" podcast — typically hosted by conservative commentator Steve Bannon, who reported to federal prison to begin serving a four-month sentence last week — Trump's top campaign advisers have stressed that Project 2025 has no official ties to his reelection bid.

Susie Wiles and Chris LaCivita, senior advisers to the Trump campaign, said in a November statement that 2024 policy announcements will be made by Trump or his campaign team.

"Any personnel lists, policy agendas, or government plans published anywhere are merely suggestions," they said.

While the efforts by outside organizations are "appreciated," Wiles and LaCivita said, "none of these groups or individuals speak for President Trump or his campaign."

In response to Trump's post last week, Project 2025 reiterated that it was separate from the Trump campaign.

"As we've been saying for more than two years now, Project 2025 does not speak for any candidate or campaign. We are a coalition of more than 110 conservative groups advocating policy & personnel recommendations for the next conservative president. But it is ultimately up to that president, who we believe will be President Trump, to decide which recommendations to implement," a statement on the project's X account said.

The initiative has also pushed back on Democrats' claims about its policy proposals and accused them of lying about what the agenda contains.

What do Democrats say?

Despite their attempts to keep some distance from Project 2025, Democrats continue to connect Trump with the transition effort. The Biden-Harris campaign frequently posts about the project on X, tying it to a second Trump term.

Mr. Biden himself accused his Republican opponent of lying about his connections to the Project 2025 agenda, saying in a statement that the agenda was written for Trump and "should scare every single American." He claimed on his campaign social media account  Wednesday that Project 2025 "will destroy America."

Congressional Democrats have also begun pivoting to Project 2025 when asked in interviews about Mr. Biden's fitness for a second term following his lackluster showing at the June 27 debate, the first in which he went head-to-head with Trump.

"Trump is all about Project 2025," Pennsylvania Sen. John Fetterman told CNN on Monday. "I mean, that's what we really should be voting on right now. It's like, do we want the kind of president that is all about Project '25?"

Rep. Jim Clyburn of South Carolina, one of Mr. Biden's closest allies on Capitol Hill, told reporters Monday that the agenda for the next Republican president was the sole topic he would talk about.

"Project 2025, that's my only concern," he said. "I don't want you or my granddaughter to live under that government."

In a statement reiterating her support for Mr. Biden, Rep. Frederica Wilson of Florida called Project 2025 "MAGA Republicans' draconian 920-page plan to end U.S. democracy, give handouts to the wealthy and strip Americans of their freedoms."

What are Republicans saying about Project 2025?

Two GOP senators under consideration to serve as Trump's running mate sought to put space between the White House hopeful and Project 2025, casting it as merely the product of a think tank that puts forth ideas.

"It's the work of a think tank, of a center-right think tank, and that's what think tanks do," Florida Sen. Marco Rubio told CNN's "State of the Union" on Sunday.

He said Trump's message to voters focuses on "restoring common sense, working-class values, and making our decisions on the basis of that."

Ohio Sen. J.D. Vance raised a similar sentiment in an interview with NBC's "Meet the Press," saying organizations will have good ideas and bad ideas.

"It's a 900-page document," he said Sunday. "I guarantee there are things that Trump likes and dislikes about that 900-page document. But he is the person who will determine the agenda of the next administration."

Jaala Brown contributed to this report.

Melissa Quinn is a politics reporter for CBSNews.com. She has written for outlets including the Washington Examiner, Daily Signal and Alexandria Times. Melissa covers U.S. politics, with a focus on the Supreme Court and federal courts.

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New Research on NeXtGen™ Biologics Inc.

An Executive Informational Overview (EIO) is now available on NeXtGen™ Biologics Inc., a closely held medical device company that holds a suite of patents for extracellular matrix (ECM) platform technology derived from the axolotl. The company aims to provide surgeons with advanced solutions for treating and managing a wide range of complex conditions in areas such as wound care, general surgery, trauma, plastic surgery, cardiovascular diseases, neurosurgery, orthopedics, and ophthalmology. The 48-page report details   the Company's business, its strategy, market opportunities, competition, risks, and more. It is available for download below.

NeXtGen™ Biologics Inc. is a medical device company that possesses a collection of patents covering extracellular matrix (ECM) platform technology sourced from the axolotl, a rare paedomorphic salamander closely related to the tiger salamander. Leveraging the Company’s innovative biotechnology, NeXtGen is seeking to unravel the mysteries of regeneration and scar-free healing using the ECM of the axolotl, as this species is capable of regenerating organs and complex tissues (including its nervous system). The Company is currently developing platform solutions to address and enhance the treatment of various intricate conditions found in wound care, general surgery, trauma, plastic surgery, cardiovascular diseases, neurosurgery, orthopedics, and ophthalmology. NeXtGen’s first FDA-cleared device, NeoMatriX® Wound Matrix, is indicated for partial and full thickness wounds, pressure venous diabetic and chronic vascular ulcers, surgical wounds, trauma wounds, Mohs surgery, and burns. NeoMatriX is provided as sheets in various sizes for placement on wound beds to help manage the wound environment.

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Out-of-pocket medical costs are substantial and rising for privately insured men with abnormal prostate cancer screening results who require further diagnostic testing.

The findings align with a recent American Cancer Society statement urging payers to eliminate costs that may keep patients from undergoing diagnostic tests following prostate cancer screening.

Prostate-specific antigen (PSA) screening aims to identify men who may harbor potentially lethal prostate cancer, and those with high PSA results often require more extensive (and expensive) diagnostic testing to establish a diagnosis. New research reveals that the out-of-pocket costs for such additional tests are substantial, common, and rising. The findings are published by  Wiley  online in  CANCER , a peer-reviewed journal of the American Cancer Society.

Abnormal screening tests (i.e., elevated PSA) warrant additional testing involving magnetic resonance imaging and/or prostate biopsies. High out-of-pocket costs for these tests—including copayment, coinsurance, and deductibles—may not only place a substantial burden on patients, but also may deter patients from going through with recommended screening.

To investigate the extent of such financial burdens, researchers analyzed information on 3,075,841 US privately insured men ages 55–69 years old who underwent PSA screening in 2010–2020. Among these men, 91,850 had a second PSA test and an elevated PSA, of which 40,329 (43.9%) underwent subsequent diagnostic testing.

Among the men who underwent subsequent testing, more than 75% experienced out-of-pocket costs. The median out-of-pocket costs rose substantially over the years of the study for patients undergoing biopsy only ($79 to $214), imaging only ($81 to $490), and imaging plus biopsy ($353 to $620).

In 2023, the American Cancer Society published a  statement  asserting that cancer screening is a multistep process, stressing that payers must eliminate out-of-pocket costs for all necessary diagnostic tests. “In the context of prostate cancer, this means that insurance companies should provide full coverage for imaging, prostate biopsy, and other recommended testing, if indicated by an abnormal prostate cancer screening test,” said lead author Arnav Srivastava, MD, MPH, of the University of Michigan, Ann Arbor. “We have seen this strategy successfully implemented in colorectal cancer screening, as part of a new addition to the Affordable Care Act. Thus, we recommend that policymakers and insurance companies offer full coverage for testing throughout the screening pathway and eliminate cost-sharing for patients.”

This study was led by Dr. Arnav Srivastava, Ms. Anca Tilea, Dr. David D. Kim, Dr. Vanessa K. Dalton, and Dr. A. Mark Fendrick.

Additional information NOTE:  The information contained in this release is protected by copyright. Please include journal attribution in all coverage. A free abstract of this article will be available via the  CANCER Newsroom  upon online publication. For more information or to obtain a PDF of any study, please contact: Sara Henning-Stout,  [email protected]

Full Citation: “Out-of-Pocket Costs for Diagnostic Testing Following Abnormal Prostate Cancer Screening Among Privately Insured Men.” Arnav Srivastava, Anca Tilea, David D. Kim, Vanessa K. Dalton, and A. Mark Fendrick. CANCER; Published Online: July 15, 2024 (DOI: 10.1002/cncr.35392) 

URL:  http://doi.wiley.com/10.1002/cncr.35392

Author Contact:  Kara Gavin at  [email protected]

About the Journal   CANCER  is a peer-reviewed publication of the American Cancer Society integrating scientific information from worldwide sources for all oncologic specialties. The objective of  CANCER  is to provide an interdisciplinary forum for the exchange of information among oncologic disciplines concerned with the etiology, course, and treatment of human cancer.  CANCER  is published on behalf of the American Cancer Society by Wiley and can be accessed online. Follow  CANCER  on X  @JournalCancer  and Instagram  @ACSJournalCancer , and stay up to date with the American Cancer Society Journals on  LinkedIn .

About Wiley        Wiley is a knowledge company and a global leader in research, publishing, and knowledge solutions. Dedicated to the creation and application of knowledge, Wiley serves the world’s researchers, learners, innovators, and leaders, helping them achieve their goals and solve the world's most important challenges. For more than two centuries, Wiley has been delivering on its timeless mission to unlock human potential. Visit us at  Wiley.com . Follow us on  Facebook ,  X ,  LinkedIn  and  Instagram .

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Great Hospitals of the Russian Federation: National Medical Research Center for Neurosurgery Named After N. N. Burdenko: History and Contemporaneity

Affiliations.

• 1 Federal State Autonomous Institution N. N. Burdenko National Medical Research Center of Neurosurgery of the Ministry of Health of the Russian Federation, Moscow, Russian Federation.
• 2 Federal State Autonomous Institution N. N. Burdenko National Medical Research Center of Neurosurgery of the Ministry of Health of the Russian Federation, Moscow, Russian Federation. Electronic address: [email protected].
• PMID: 30096505
• DOI: 10.1016/j.wneu.2018.07.280

In 1929 the surgeon N. N. Burdenko and the neurologist V. V. Kramer founded the first neurosurgical clinic in Moscow, which gained the status of Neurosurgery Institute in 1932. It went through a difficult path of military and peaceful years, overcoming all kinds of obstacles. It was constantly developed, built, and upgraded as it evolved to the National Medical Research Center for Neurosurgery. The history of the center is reviewed in this article, highlighting the notable personalities that have influenced the development of neurologic surgery and its scientific background in the Russian Federation.

Keywords: Education; N. N. Burdenko Neurosurgery Center; N. N. Burdenko Neurosurgery Institute; Neurosurgery history; Russian neurosurgery.

Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

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• [Neurosurgery in Moscow: clinic - institute - ational center]. Potapov AA, Likhterman LB, Danilov GV. Potapov AA, et al. Zh Vopr Neirokhir Im N N Burdenko. 2019;83(1):5-16. doi: 10.17116/neiro2019830115. Zh Vopr Neirokhir Im N N Burdenko. 2019. PMID: 30900684 Russian.
• Emergence and early development of Russian neurosurgery (1890s-1930s). Lichterman B. Lichterman B. J Hist Neurosci. 2007 Jan-Jun;16(1-2):123-37. doi: 10.1080/09647040600700245. J Hist Neurosci. 2007. PMID: 17365558
• Best Research Practice Implementation: The Experience of the N.N. Burdenko National Medical Research Center of Neurosurgery. Danilov G, Shifrin M, Strunina Y, Ishankulov T, Zagidullin T, Makashova E, Pronin I, Konovalov N, Potapov A. Danilov G, et al. Stud Health Technol Inform. 2021 Nov 18;287:40-44. doi: 10.3233/SHTI210808. Stud Health Technol Inform. 2021. PMID: 34795076
• Neurosurgery at Kasturba Medical College: Past, present and future. Menon G, Nair R, Laskhman IK, Kumar V, Prasad GL. Menon G, et al. Neurol India. 2017 Sep-Oct;65(5):1105-1111. doi: 10.4103/neuroindia.NI_564_17. Neurol India. 2017. PMID: 28879906 Review.
• [History of neurosurgery at the provincial hospital of Guipuzcoa]. Urculo-Bareño E. Urculo-Bareño E. Neurocirugia (Astur). 2009 Apr;20(2):163-75. Neurocirugia (Astur). 2009. PMID: 19448961 Review. Spanish.
• Alexander Alexandrovich Potapov, MD, PhD, 1948-2021. Kato Y. Kato Y. Asian J Neurosurg. 2021 May 28;16(2):437-442. doi: 10.4103/1793-5482.317007. eCollection 2021 Apr-Jun. Asian J Neurosurg. 2021. PMID: 34268182 Free PMC article. No abstract available.

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