Retail Pharmacies Are Working with Pharmaceutical Companies to Recruit and Enroll Patients in Decentralized Clinical Trials

This trend, which began during the COVID-19 pandemic, may bypass those clinical laboratories and pathology groups that recruit patients for clinical trials, but increase the diversity of the pool of study participants

National retail pharmacy chains are seeking new lines of business in the healthcare market and their efforts could cost clinical laboratories and pathology groups revenue. Their strategy is to identify patients who are candidates for specific clinical trials and connect them with clinical trial managers for enrollment, according to CNET.

This comes on the back of the US Food and Drug Administration’s (FDA) move to decentralize clinical trials, which got started during the COVID-19 pandemic, and support clinical trials that covered a wider swath of the American population.

Dark Daily first covered this trend in “Walgreens Launches Clinical Trial Business with Goal of Leveraging Consumer Data, Technology, and Nationwide Reach to Increase Racial and Ethnic Diversity in Drug Research.” We reported how Walgreens was launching a business to connect customers with clinical drug trials, a venture that adds another offering to the retail pharmacy giant’s growing menu of healthcare services.  

Traditionally, there are clinical laboratories and anatomic pathology groups that actively work to connect their patients with appropriate clinical trials (and earn revenue for both the enrollment and doing necessary testing of the patient in support of the trial). Now, following the FDA’s lead, pharmacy companies seem to be working to capture some of that revenue.

“COVID-19 was definitely the impetus for reevaluating how we did clinical trials,” Ramita Tandon, Chief Clinical Trials Officer at Walgreens, told CNET. The interest of retail pharmacies in the business of identifying their patients as candidates for clinical trials is a development that clinical lab managers and pathologists may want to monitor. (Photo copyright: Walgreens.)

Customer Demand for Convenience a Factor

Clinical trials are imperative to the drug approval process required by the FDA’s Center for Drug Evaluation and Research (CDER). The COVID-19 pandemic fueled the FDA’s move to decentralize clinical trials to help pharmaceutical companies recruit subjects for drug testing.

Retail pharmacy chains apparently saw that as the latest opportunity to position retail pharmacies as intermediaries between drug manufacturers and patients.

In response to growing demand for convenient healthcare locations, Walgreens, CVS, Rite Aid, and Walmart have all installed primary care clinics into their retail pharmacies and added vaccinations. Further, after COVID-19 caused retail pharmacy chains to sell over-the-counter SARS-CoV-2 home test kits, pharmacies sought to offer more diagnostic test options to their customers, which would further direct such tests away from clinical laboratories.

Over the last two years, Walgreens, Walmart, CVS, and Kroger have also added clinical trials divisions to their corporate holdings. Among the companies’ stated goals is to make clinical trials more accessible and convenient for their customers, as well as to recruit more trial participants from underrepresented populations. 

According to an article published in the Journal of Medical Internet Research (JMIR), “around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies.” This shortfall may delay the creation of useful drugs, medical devices, and other essential treatments. 

“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,’” Ramita Tandon, Chief Clinical Trials Officer at Walgreens, 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.”

Creating a More Diverse Group of Clinical Trial Participants

CNET reported that “Pfizer, Gilead, and other biopharmaceutical companies are eager to diversify their patient pool.”

According to the FDA’s 2022 Drug Trials Snapshot, “Whites comprised the majority of patients enrolled in most of the pivotal trials supporting approval of all 37 novel therapies, followed by Asians and Blacks.”

Walgreens, which operates 8,698 pharmacies in 53 states and territories, has installed special clinical trial centers at 15 pharmacies and has approximately one dozen clinical trials in various stages. Tandon said more than two million Walgreens customers have already been contacted about participating in clinical trials.

In January, grocery giant Kroger announced its first clinical trial partnership with Persephone Biosciences to locate subjects for a study on gut health and its influence on colorectal cancer. Data collected from this trial will help develop personalized medicines and discover cancer-specific indicators that may be beneficial in guiding treatments and preventative measures. 

Kroger Health operates nearly 2,200 pharmacies across the US, including 11 specialty pharmacies and 225 clinics.

In October of last year, Walmart announced the creation of the Walmart Healthcare Research Institute (WHRI), which will focus on innovative interventions and medications to help communities that are unrepresented in clinical trials, such as older adults, rural residents, women and minority populations.

Walmart operates over 3,000 pharmacies in 49 states. Ninety percent of Americans live within ten miles of a Walmart, which translates to the retailer being able to reach a large number of candidates for clinical trials.

Study findings published by marketing research company Precedence Research illustrate how the business of clinical trials generated more than $48 billion last year and is projected to reach over $83 billion by 2032. (Graphic copyright: Precedence Research.)

CVS Discontinues Decentralized Clinical Trial Business

CVS Health was the first pharmacy to launch a clinical trials program back in May 2021. However, in May of this year, the company announced it was shuttering that portion of its business.

CVS Health expects to fully phase out its clinical trials unit by the end of 2024, citing “the need to align existing businesses with its larger corporate strategy,” according to BioSpace.

“Fully decentralized models preclude a huge swath of possible research because of safety and regulatory concerns,” Steve Wimmer, Vice President of Partnerships at decentralized clinical trial recruiter 1nHealth, told BioSpace. “It’s difficult to conduct such trials in a standardized manner. I think [CVS] may have imagined that a clinical study visit wouldn’t be that different from the primary care visits they already do. But for interventional, go-to-study trials, it’s not the same as a primary care visit.”

According to the US National Library of Medicine, more than 38,000 registered clinical studies occurred in 2022. As of August 24 of this year, 26,237 clinical studies have been registered on

There are clinical laboratories and anatomic pathology groups that actively work to connect their patients with those clinical trials. Though pharmacy companies’ clinical trial recruitment programs may reduce revenue for those labs and pathologists, the increased participation in such trials by greater numbers and more diverse populations of people could advance the development of new lifesaving treatments and therapies, which is good for everyone.  

—JP Schlingman

Related Information:

Clinical Trials Are Now at Your Local Drugstore. What That Means for You

Walgreens Launches Clinical Trial Business with Goal of Leveraging Consumer Data, Technology, and Nationwide Reach to Increase Racial and Ethnic Diversity in Drug Research

FDA: Decentralized Clinical Trials for Drugs, Biological Products, and Devices

FDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices

US National Library of Medicine: Trends, Charts, and Maps

Healthcare Clinical Trials Market

Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis

FDA: Drug Trials Snapshots Summary Report 2022

Kroger Health Establishes Clinical Trial Site Network to Increase Reach and Access to Research Studies

Walmart’s Healthcare Research Institute Launches with Mission to Improve Care for Underserved Communities Through Research

CVS Health Winding Down Clinical Trial Business  

CMS Proposes New Amendments to Federal Hospital Price Transparency Rule That May Affect Clinical Laboratories and Pathology Groups

Proposal comes as patient advocacy group reports poor compliance by hospitals with the federal price transparency regulation; AHA pushes back

Recent data compiled by Patient Rights Advocate, a non-profit group dedicated to nationwide healthcare transparency, appears to indicate that as many as two thirds of US hospitals continue to ignore hospital transparency rules established by Congress in 2021, according to an op-ed published in the Washington Examiner.

This may be why the Biden Administration has now proposed new amendments aimed at strengthening those requirements. According to KFF Health News (formerly Kaiser Health News), this new proposal “aims to further standardize the required data, increase its usefulness for consumers, and boost enforcement.”

However, “the goal of exact price tags in every situation is likely to remain elusive,” KFF Health News noted.

“Noncompliant hospitals are preventing patients and payers from shopping around for high-value care—and inflating healthcare costs in the process,” wrote Sally C. Pipes, President and CEO of Pacific Research Institute, in her Washington Examiner column.

Pathologists who were near the top of a Health Care Cost Institute (HCCI) list of medical specialties that most often billed out of network may be affected by CMS’ proposed new amendments to the transparency rule.

“The nonprofit group Patient Rights Advocate just published its fifth report exploring how hospitals are complying with federal price transparency requirements. About two-thirds are still flouting the rules. That’s unacceptable,” wrote Sally Pipes (above), President and CEO of Pacific Research Institute, in an op-ed she penned for the Washington Examiner. Federal law also requires clinical laboratories to post their prices for testing. (Photo copyright: The Heartland Institute.)

Hospitals, Clinical Laboratories Required to Post Chargemaster Prices

The proposed amendments were part of a larger proposed rule published in the July 31, 2023, Federal Register by the Centers for Medicare and Medicaid Services (CMS).

Dark Daily has long been reporting on the federal government’s efforts to mandate Hospital Price Transparency (HPT). Beginning Jan. 1, 2019, hospitals have been required to post pricing information on their websites, as Dark Daily reported in “New CMS Final Rule Makes Clinical Laboratory Test/Procedure Pricing Listed on Hospital Chargemasters Available to Public.”

That rule required hospitals to disclose chargemaster prices, essentially the “list prices” for hospital procedures.

But a year later, as we reported in “Hospital Associations and Healthcare Groups Battle HHS Efforts to Expand Pricing Transparency Rules to Include Negotiated Rates with Payers,” the CMS passed a final rule that required disclosure of prices negotiated with payers.

That rule also required hospitals to provide a list of charges for at least 300 “shoppable services,” including at least 14 laboratory and pathology tests.

“We’re closer to that, but we’re not there,” Gerard Anderson, PhD, a professor at the Johns Hopkins Bloomberg School of Public Health, told KFF. The goal may be the kind of pricing transparency that consumers are accustomed to when purchasing goods and services, but healthcare, he said, poses unique challenges.

“Each patient is unique and uses a slightly different bundle of services,” Anderson added. “You might be in the operating room for 30 minutes, or it might be 45. You might need this lab test and not that one.”

The KFF Health News story noted that health insurers have been subject to even stricter regulations, “with more prescriptive details and tougher penalties for noncompliance,” since 2022. CMS’ latest proposed amendments would bring requirements for hospitals that are more in line with those that apply to payers, KFF reported.

As described in the Federal Register, the proposed rule aims to:

  • Improve standardization of machine-readable file (MRF) formats and data elements.
  • Require hospitals to include a new data element known as the “consumer-friendly expected allowed charges,” KFF Health News noted.
  • Require hospitals to “affirm the accuracy and completeness of their standard charge information displayed in the MRF.”
  • Require hospitals to place a link to pricing information in the footers of their web pages.

The rule also includes provisions for enhanced enforcement of pricing transparency requirements. Under one proposal, CMS would publicly identify hospitals that are not in compliance.

Jeffrey Leibach, MBA, a healthcare finance strategist and Partner with the consulting firm Guidehouse, told KFF Health News that the new rules will make it easier for third-party data firms to create online price comparison tools. “And, ultimately, consumers who want to shop will then find this data more easily,” he said.

The proposal comes on the heels of a July report from Patient Rights Advocate (PRA) indicating that only 36% of US hospitals were in full compliance with the current transparency requirements. The report was based on an analysis of 2,000 hospital websites. However, that was an improvement over earlier reports. In February, the group reported that 24.5% were fully compliant, compared with 16% in August 2022.

Most hospitals in the report posted negotiated prices, but in many cases, “their pricing data was missing or significantly incomplete,” PRA contended. A total of 69 hospitals “did not post a usable standard charges file,” the report stated.

PRA Uses Humor to Highlight Discrepancies, AHA Pushes Back

According to KFF Health News, PRA is running a satirical ad campaign in which retailers adopt the “hospital pricing method,” listing estimates on store shelves instead of actual prices.

“When they ask for a price, we give them an estimate,” says one retail manager in the video ad. “Then we bill them whatever we want.”

This new video pokes fun at the lack of price transparency in healthcare. The American Hospital Association took issue with the clip’s tone.

“People need price certainty,” PRA founder and Chairman Cynthia Fisher, MBA, told KFF Health News. “Estimates are a way of gaming the people who pay for healthcare.”

However, executives from the American Hospital Association (AHA) pushed back on the video ad and PRA’s claims about HPT compliance. AHA contends that hospitals were flagged as being noncompliant if they left spaces blank or used formulas, both of which are permitted under the current rules.

“Very few health services are so straightforward where you can expect no variation in the course of care, which could then result in a different cost than the original assessment,” AHA Group Vice President for public policy Molly Smith, MS, told KFF. “Organizations are doing the best they can to provide the closest estimate. If something changes in the course of your care, that estimate might adjust.”

As for the July PRA report, in a July 25 AHA press release, Smith stated, “Patient Rights Advocate has put out a report that blatantly misconstrues, ignores, and mischaracterizes hospitals’ compliance with federal price transparency regulations.”

CMS, she said, “has found that as of last year 70% of hospitals had complied with both federal requirements and over 80% had complied with at least one. Due to the ongoing efforts of the hospital field, these numbers are surely higher today. Third party analyses have agreed that hospitals have made tremendous progress.”

But then what is motivating the government’s new amendments to the price transparency rule? Regardless, clinical laboratories and pathology groups should continue to monitor progress of these new amendments to the federal hospital transparency rule.

—Stephen Beale

Related Information:

Hospitals Are Still Neglecting Transparency Rules

Proposed Rule Would Make Hospital Prices Even More Transparent

CMS Proposes Updates to the Hospital Price Transparency Rule

A Progress Check on Hospital Price Transparency

Price Transparency: A Boon For Patients, a Bust for Hospitals?

Just More than a Third of Hospitals Are Complying with Price Transparency Rules

Calgary’s Long Clinical Laboratory Waits at Patient Service Centers Prompt Alberta Health Services to Add Extra Appointments, Temporary Locations

As patients and staff suffer with lengthening wait times, critics claim proposed solutions won’t remedy the ailing system of collecting medical laboratory specimens

With a backlog of lab appointments and a plethora of long wait times for phlebotomy services in the Canadian Province of Alberta, Alberta Health Services (AHS) is feeling the heat. As a result, Alberta Precision Laboratories is making efforts to improve services by adding 400 appointments in Calgary, CBC News reported.

The government-owned clinical laboratory lab company added these appointments at Peter Lougheed Centre and South Health Campus, both in Calgary, with 175 additional appointments coming down the line at the Foothills Medical Centre, also in Calgary, the CBC reported.

AHS is targeting “areas of high demand” and the efforts to bolster services include adding weekend appointments and “temporary new locations” the Calgary Herald reported.

The ripple effect from such delays in Canada’s public healthcare system are widespread and ruffling the feathers of patients, staff, and critics alike. Clinical laboratories in the United States may learn from watching how the Canadian health system resolves these issues.

“As of today, there were waits of upwards of 90 minutes for an appointment that’s already scheduled. That’s unacceptable,” Adriana LaGrange, Alberta’s Minister of Health, told CBC News. (Photo copyright: CBC News.)

Short- and Long-Term Efforts

Densely-populated Calgary and its surround areas have been experiencing increasingly long waits in the last few months. The Calgary Herald reported that their efforts to schedule a new lab appointment brought about only a handful of appointment times a few weeks out, with the majority of open times being five weeks out.

“I’ve heard some really distressing stories on how long it’s taken to get necessary lab work back,” Adriana LaGrange, Alberta’s Minister of Health, told CBC News. “This impedes the ability for physicians to make diagnoses, and we just can’t have that,” she added.

The 400 new appointments are “part of an arrangement worked out between Alberta Precision Labs and DynaLIFE, the private clinical laboratory provider that handles the bulk of community lab appointments in Alberta,” CBC News reported.

DynaLIFE, formerly Dynacare Kasper Medical Laboratories (DKML), is partly owned by Labcorp.

Alberta Precision Laboratories is “working on extending hours, hiring other third-party providers, and opening or expanding satellite centers [patient service centers] in and around Calgary to add 7,500 appointments per week, which would represent a 25% increase in the area,” LaGrange told CBC News.

“In the short term, we will provide the necessary appointments that are needed by Albertans, particularly in Calgary and the south area. In the long-term, we’ll work towards something where there’s more stability in the system,” she added.

Lengthy Waits to Receive Medical Laboratory Test Results

Patients and doctors in Calgary “say wait times for blood work and quality of services remain a concern under DynaLIFE Medical Labs who took operation over community labs last year,” the Calgary Herald reported.

“One Calgary doctor who asked to stay anonymous for fear of professional reprimand said she’s hearing from patients who have travelled out of the city to labs as far as Canmore or Didsbury to get testing done. She added her colleagues have complained about lengthy waits to receive lab results and said sometimes results aren’t sent at all or are directed to the wrong clinic,” the Calgary Herald reported.

At one DynaLIFE location, one patient waited two hours and 20 minutes for her previously-scheduled lab work even though online the wait time showed just 11 minutes, the Calgary Herald reported. “I don’t understand how anyone can get lab work done and work or look after their kids,” she said.

It is not clear why DynaLIFE is missing its published benchmarks.

AHS No Stranger to Controversy

Government health programs in many countries lack the necessary capital to train and employ adequate numbers of doctors, nurses, and other medical professionals, or to expand clinics/hospitals, clinical laboratories, or radiology services. Thus, demand generally exceeds supply and so government health systems ration care using wait times.

This is one factor in the Alberta story.

In Alberta, since the 1990s, various attempts by the AHS to expand clinical laboratory testing volumes/capabilities in advance of need have seesawed as liberal/conservative governments came and went—each with their own agenda on how healthcare should be organized.

Dark Daily’s sister publication The Dark Report covered that trend in “Alberta Health to Build New Lab to Serve Edmonton, Province.” We reported how following years of controversy associated with different plans to build a large new laboratory facility to serve Edmonton and the surrounding region, Alberta Health Services ended up financing and building the new lab with its own resources.

This was preceded by an announcement that the Alberta government would develop a new central laboratory to process 80% of the clinical laboratory tests in the Edmonton region and become the central lab for a new system from Alberta Health Services to process lab tests in the province.

At that time, Alberta had six different organizations providing clinical laboratory services. Having so many organizations involved in clinical laboratory testing services, according to then Alberta Health Minister Sarah Hoffman, resulted in a “needlessly complex and fragmented system.”

All of this explains why Calgary is experiencing wait times for phlebotomy that are frustrating patients. It’s a cautionary tale that clinical laboratory managers in this country may want to study.

—Kristin Althea O’Connor

Related Information:

Alberta Expands Medical Lab Test to Reduce Long Waits, Particularly in Calgary

Long Community Lab Wait Times Continue Under DynaLIFE for Calgary Patients

Alberta Health to Build New Lab to Serve Edmonton, Province

NHS Trial Analysis Finds That Grail’s Galleri Clinical Laboratory Blood Test Can Detect 50 Cancers and Identify the Location of the Cancer

Though a ‘work in progress,’ the Oxford researchers who conducted the trail believe the MCED blood test could help doctors give better cancer assessments

Cancer is typically diagnosed through tissue biopsies that are often invasive and painful for patients. Now, recently-released results of a National Health Service (NHS) trial study of a relatively new multi-cancer early detection test (MCED) may provide a less painful/invasive cancer test experience to UK residents.

Developed by California-based healthcare technology company Grail, the clinical laboratory blood test—called Galleri—can detect 50 cancer types and, according to the company’s website, even identify the cancer’s location within the body. It is currently only available through a doctor’s prescription.

Researchers have long sought to improve screening methods and diagnostic technologies that identify cancers more easily and at an earlier stage. They recognize that a simple, inexpensive laboratory blood test—as opposed to a tissue biopsy—that detects both the presence of multiple cancer types and its location would benefit both medical professionals and patients worldwide.

The NHS trial study of the Galleri MCED test—dubbed SYMPLIFY—began in 2021. It is “a collaboration between the University of Oxford’s Department of Oncology, the Cancer Research Group at the Nuffield Department of Primary Care Health Sciences, the Oncology Clinical Trials Office, and the Primary Care Clinical Trials Unit,” according a 2021 University of Oxford press release.

The researchers published their findings in The Lancet Oncology titled, “Multi-cancer Early Detection Test in Symptomatic Patients Referred for Cancer Investigation in England and Wales (SYMPLIFY): a Large-scale, Observational Cohort Study.”

“The [Galleri] test was 85% accurate in detecting the source of the cancer, and that can be really helpful because so many times it is not immediately obvious when you have got the patient in front of you what test is needed to see whether their symptoms are down to cancer,” said Mark Middleton, MD, PhD, head of the Department of Oncology at the University of Oxford and lead researcher of the study, in a BBC interview. (Photo copyright: University of Oxford.)

Details of the SYMPLIFY Study

To conduct the SYMPLIFY study, Oxford researchers enrolled 6,238 adults in England and Wales who were referred for imaging and diagnostic testing with symptoms that were indicative of gynecological, lung, or lower/upper GI cancers, or with non-specific symptoms. The most commonly reported symptoms that triggered the referrals were:

  • Weight loss (24.1%)
  • Change in bowel habits (22.0%)
  • Post-menopausal bleeding (16.0%)
  • Rectal bleeding (15.7%)
  • Abdominal pain (14.5%)
  • Pain (10.6%)
  • Difficulty swallowing (8.8%)
  • Anemia (7.1%)

DNA from cancer cells—called ctDNA (circulating tumor DNA)—can be detected in blood samples at early tumor stages. The Galleri MCED test was performed on cell-free DNA taken from blood samples provided by the study participants. The test was performed in batches and blinded to results of previous diagnostic tests.

The predictions of the test were then compared to diagnoses received via traditional diagnostic testing and imaging. 

According to the Oxford researchers’ Lancet paper, GRAIL’s MCED test detected a cancer signal in 323 of the study participants. Of those individuals, 244 received a cancer diagnosis, resulting in a positive predictive value (PPV) of 75.5%, a negative predictive value (NPV) of 97.6%, and a specificity of 98.4%.

The overall sensitivity of the Galleri test was 66.3%, representing a range from 24.2% in Stage 1 cancers to 95.3% in stage IV cancers. The mean age of the study participants was 62.1 years old, and the sensitivity increased with age and cancer stage.

The overall accuracy of the top Cancer Signal Origin (CSO) prediction following a positive MCED test was 85.2%, the researchers concluded.

“With that prediction from the test, we can decide whether to order a scope or a scan and make sure we are giving the right test the first time,” Mark Middleton, MD, PhD, head of the Department of Oncology at the University of Oxford and lead researcher of the study, told BBC News.

The most common cancers detected among the study participants were:

“Earlier cancer detection and subsequent intervention has the potential to greatly improve patient outcomes. Most patients diagnosed with cancer first see a primary care physician for the investigation of symptoms suggestive of cancer, like weight loss, anemia, or abdominal pain, which can be complex as there are multiple potential causes,” said Brian Nicholson, DPhil, Associate Professor at Oxford’s Nuffield Department of Primary Care Health Sciences and co-lead investigator for the study in a 2023 Oxford press release. “New tools that can both expedite cancer diagnosis and potentially avoid invasive and costly investigations are needed to more accurately triage patients who present with non-specific cancer symptoms.

“The high overall specificity, positive predictive value, and accuracy of the cancer signal detected and cancer signal origin prediction that was reported across cancer types in the SYMPLIFY study indicate that a positive MCED test could be used to confirm that symptomatic patients should be evaluated for cancer before pursuing other diagnoses,” he added.

MCED Test May Help Doctors Better Assess Cancer

The SYMPLIFY study is the first large-scale analysis of an MCED test in patients who were referred by their doctors for diagnostic testing due to suspected cancers. The results of the study were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in June.

Middleton told BBC News that the test is not yet accurate enough to “rule in or rule out cancer,” but it was useful for researchers and patients.

“The findings from the study suggest this test could be used to support GPs to make clinical assessments but much more research is needed, in a larger trial, to see if it could improve GP assessment and ultimately patient outcomes,” David Crosby, PhD, head of Prevention and Early Detection Research, Cancer Research, UK, told BBC News.

Scientists at the University of Oxford were responsible for data collection, analysis, and interpretation of the data used for the study. The study was funded by GRAIL with support from National Health Service England (NHS), NHS Wales, the National Institute for Health and Care Research (NIHR), and the NIHR Oxford Biomedical Research Centre

Clinical laboratories and anatomic pathology groups that perform tissue biopsy testing for oncologists will want to monitor the progress of this simple blood test that may someday reduce the number of invasive, painful biopsies required to diagnose cancer and other health considerations.

—Jillia Schlingman

Related Information:

Multi-cancer Early Detection Test in Symptomatic Patients Referred for Cancer Investigation in England and Wales (SYMPLIFY): a Large-scale, Observational Cohort Study

Multi-cancer Blood Test Shows Real Promise in NHS Study

Multi-cancer Blood Test Shows Real Promise in NHS Trial

SYMPLIFY: Observational Study to Assess a Multi-Cancer Early Detection Test in Individuals Referred with Signs and Symptoms of Cancer

Galleri: The First Clinically-validated MCED Test

GRAIL and University of Oxford to Present Results from First Prospective Study of Multi-Cancer Early Detection in a Symptomatic Patient Population at 2023 ASCO Annual Meeting

British Medical Laboratory Test for Early Screening of Lung Cancer Shows Promising Interim Results in Large Trial; Could Lead to Other Simple Blood Tests for Cancer Detection

Clinical Evaluation of Cancer Signal Origin Prediction and Diagnostic Resolution Following Multi-cancer Early Detection Testing

Scientists and Medical Professionals Face Huge Fees, Court Costs after Speaking at Certain COVID-19 Webinars

Little-known Polish company relied on suspect arbitration court to demand thousands of euros from conference speakers

Clinical laboratory and pathology professionals may want to heed the phrase “caveat emptor” (“let the buyer beware”) if invited to speak at events organized by little-known entities. That appears to be the lesson from a rather bizarre story coming out of Poland involving scholars from multiple countries who agreed to speak during a series of online COVID-19 webinars and who were later billed thousands of euros for their participation.

In “Costly Invite? Scientists Hit with Massive Bills after Speaking at COVID-19 ‘Webinars,’Science magazine reported that in 2020 and 2021, dozens of researchers were invited by a Polish company called Villa Europa to speak in a series of online conferences about modeling of COVID-19.

But months after the event, the organizer demanded payment for the researchers’ participation, and in some cases, turned to a Polish arbitration court to enforce the demand. But in a curious twist, the legitimacy of that court has itself been called into question.

“I was interested in the topic, and I agreed to participate,” Björn Johansson, MD, told Science. “I thought it was going to be an ordinary academic seminar. It was an easy decision for me.” Johansson, a physician and researcher at the Karolinska Institute in Sweden, has since “come to regret that decision,” the publication reported.

Villa Europa is now seeking €80,000 ($86,912 in current US dollars) from Johansson, including legal costs and interest, after turning to a Swedish court. Others have received demands for €13,000 to €25,000 ($14,123 to $27,156) in fees, late payment penalties, and court costs, Science reported.

Researchers Axel Brandenburg, PhD (left), and Björn Johansson, MD (right), are two of the 32 scholars from six countries who are now being billed thousands of euros for their participation in the Villa Europa COVID-19 modeling webinars. Pathology and clinical laboratory leaders who receive similar invitations may want to thoroughly read the contracts before agreeing to participate. (Photo copyright: Axel Brandenburg, Björn Johansson.)

How Did It All Happen?

According to Science, the ordeal began when an individual named Matteo Ferensby invited the scientists to speak at the webinars. His email signature indicated an affiliation with the University of Warsaw, but the university “has no employee by that name, according to the institution’s press office,” Science reported, adding that “there is no track record of scientific publications from a Matteo Ferensby.”

By one speaker’s count, the company produced at least 11 webinars between April 2020 and June 2021. “The speakers themselves—about 10 people in each session—were the only audience, but participants were told the recordings would be published open access afterward,” Science reported.

Ferensby did not disclose that speakers would be charged conference fees. In fact, one speaker was told explicitly that no fees would be requested, Science noted.

However, the speakers were later asked to sign a license agreement that would allow the organizer to publish the recordings. It included a clause on the last page stating that they would have to pay fees of €790 and €2785 (US$859 and $3,029) related to publication.

The financial amounts were written in words rather than numbers with no highlighting, according to Science, which reviewed some of the contracts.

“Many of the speakers, already busy studying COVID-19 and under pressure from the transition to remote teaching, did not notice these clauses,” Science reported. Said one speaker: “The contract was unreadable [but] I eventually sent it.”

Questionable Arbitration

Some of the webinar participants told Science that they later received altered versions of the contracts with “an additional page where the fees are made explicit, and [with] modified clauses, one of them stating that disputes can be settled by a Polish arbitration court.”

That court, identified as Pan-Europejski-Sąd-Arbitrażowy (Pan European Arbitration Court or PESA), apparently does not exist. Agnieszka Durlik, JD, Director General of The Arbitration Court at the Polish Chamber of Commerce, told Science that she had never heard of PESA, and it that appears Villa Europa set up the PESA website.

“In my opinion this is fraud,” Durlik said. Nevertheless, Villa Europa used alleged rulings by PESA to go after some of the speakers in their own local courts.

“For the researchers now under pressure from the courts, ignoring the demands is not an option,” Science reported. “They have all submitted court filings supporting their case.”

The speakers claim that “the demands are illegitimate and that they were deceived about what they were signing in the contracts,” Science noted. One speaker, Axel Brandenburg, PhD, of the Nordic Institute for Theoretical Physics (NORDITA), is awaiting a ruling in September, Science reported.

Warnings against Predatory Conferences

The story comes amid increasing concerns about so-called “predatory conferences,” in which scientists are invited under false pretenses to participate in what appear to be legitimate meetings.

“Would-be attendees should expect missing plenary speakers, multiple fields of research smashed together in a Frankenstein program, and an absence of the important academic rigor that fuels the conferences that scientists know and love,” wrote senior science writer Ruairi J. Mackenzie in Technology Networks. “The companies organizing these events are motivated by profit above all else.”

Mackenzie offered several tips to help both speakers and attendees spot fake conferences:

  • Examine the promotional materials. “Whether you are studying an unprompted email or a conference webpage, look for shoddy writing quality or outlandish layouts.”
  • Check with your colleagues. “The dominant conferences in your field are probably in that position because they have proved time and time again that they can deliver a valuable experience for attendees.”
  • Look at other conferences from the same producer. If a company produces a high volume of conferences on a wide range of topics, that can be a sign that the quality will be shoddy, he suggested.
  • Look at the contact information. A legitimate conference should have ties to an established society or conference organizer. Get the address, and then look at that location in Google Street View to see if it’s the kind of building where you’d expect a legitimate company to be located.

The experience of these 32 scientific and medical scholars demonstrates that there is always a new twist in how honest citizens can be defrauded. For that reason, clinical laboratory managers and pathologists should be wary when approached by unknown organizations with speaking invitations, particularly in Europe.

—Stephen Beale

Related Information:

Costly Invite? Scientists Hit with Massive Bills after Speaking at COVID-19 ‘Webinars.’

The Ultimate Guide to Avoiding Predatory Conferences

The Alarming Rise of Predatory Conferences

The Ethics Blog: Predatory Conferences

Arbitrarily Applied: Another COVID-19 Scam, This Time On Scientists

Researchers Find AI Improves Breast Cancer Detection by 20%

Initial analyses also shows AI screening lowers associated radiologist image reading workload by half

Both radiologists and pathologists analyze images to make cancer diagnoses, although one works with radiological images and the other works with tissue biopsies as the source of information. Now, advances in artificial intelligence (AI) for cancer screenings means both radiologists and pathologists may soon be able to detect cancer more accurately and in significantly less time.

Pathologists may find it instructive to learn more about how use of this technology shortened the time for the radiologist to sign out the case without compromising accuracy and quality.

Led by researchers at Lund University in Sweden, the Mammography Screening with Artificial Intelligence (MASAI) trial found that using AI during high-risk breast cancer screenings improved breast cancer detection by 20% without affecting the number of false positives, according to a Lund University news release.

Even better, AI screenings reduced doctors’ workload in interpreting mammography  images by nearly 50%, the news release states. Such an improvement would also be a boon to busy pathology practices were this technology to become available for tissue biopsy screenings as well. 

The researchers published their findings in the journal The Lancet Oncology titled, “Artificial Intelligence-Supported Screen Reading versus Standard Double Reading in the Mammography Screening with Artificial Intelligence Trial (MASAI): a Clinical Safety Analysis of a Randomized, Controlled, Non-Inferiority, Single-Blinded Screening Accuracy Study.“

“The greatest potential of AI right now is that it could allow radiologists to be less burdened by the excessive amount of reading,” said breast radiologist Kristina Lång, MD, PhD, Associate Professor in Diagnostic Radiology at Lund University. Pathologists working with clinical laboratories in cancer diagnosis could benefit from similar AI advancements. (Photo copyright: Lund University.)

Can AI Save Time and Improve Diagnoses?

One motivation for conducting this study is that Sweden, like other nations, has a shortage of radiologists. Given ongoing advances in machine learning and AI, researchers launched the study to assess the accuracy of AI in diagnosing images, as well as its ability to make radiologists more productive.

The MASAI trial was the first to demonstrate the effectiveness of AI-supported screening, the Lund news release noted.

“We found that using AI results in the detection of 20% (41) more cancers compared with standard screening, without affecting false positives. A false positive in screening occurs when a woman is recalled but cleared of suspicion of cancer after workup,” said breast radiologist Kristina Lång, MD, PhD, clinical researcher and associate professor in diagnostic radiology at Lund University, and consultant at Skåne University Hospital, in the news release.  

Not only did the researchers explore the accuracy of AI-supported mammography compared with radiologists’ standard screen reading, they also looked into AI’s effect on radiologists’ screen-reading workload, the Lancet paper states.

Impetus for the research was the shortage of radiologists in Sweden and other countries. A Lancet news release noted that “there is a shortage of breast radiologists in many countries, including a shortfall of around 41 (8%) in the UK in 2020 and about 50 in Sweden, and it takes over a decade to train a radiologist capable of interpreting mammograms.”

That makes it even more challenging for providers to meet European Commission Initiatives on Breast and Colorectal Cancer (ECIBC) recommendations that two radiologists screen a woman’s mammogram, the Lancet news release pointed out.

More Breast Cancer Identified with Lower Radiologist Workload When Using AI Screening

Here are study findings, according to the Lancet paper:

  • AI-supported screening resulted in 244 cancers of 861 women recalled.
  • Standard screening found 203 screen-detected cancers among 817 women who were recalled.
  • The false positive rate of 1.5% was the same in both groups.
  • 41 (20%) more cancers were detected in the AI-enabled screening group.
  • Screen readings by radiologists in the AI-supported group totaled 46,345, as compared to 83,231 in the standard screening group.
  • Workload dropped by 44% for physicians using screen-reading with AI.

“We need to see whether these promising results hold up under other conditions—with other radiologists or other algorithms,” Lang said in the Lund news release.

“The results from our first analysis show that AI-supported screening is safe since the cancer detection rate did not decline despite a reduction in the screen-reading workload,” she added.

Is AI a Threat to Radiologists?

The use of AI in the Swedish study is an early indication that the technology is advancing in ways that may contribute to increased diagnostic accuracy for radiologists. But could AI replace human radiologists’ readings. Not anytime soon.

“These promising interim safety results should be used to inform new trials and program-based evaluations to address the pronounced radiologist shortage in many countries. But they are not enough on their own to confirm that AI is ready to be implemented in mammography screening,” Lång cautioned. “We still need to understand the implications on patients’ outcomes, especially whether combining radiologists’ expertise with AI can help detect interval cancers that are often missed by traditional screening, as well as the cost-effectiveness of the technology.”

In an Advisory Board daily briefing, breast radiologist Laura Heacock, MD, of the NYU Langone Perlmutter Cancer Center said, “If you spend a day with a radiologist, you’ll see that how an AI looks at screening a mammogram is really just a fraction of how radiologists practice medicine, even in breast imaging.

“These tools work best when paired with highly trained radiologists who make the final call on your mammogram. Think of it as a tool like a stethoscope for a cardiologist,” she added.

Whether a simple tool or an industry-changing breakthrough, pathology groups and clinical laboratories that work with oncologists can safely assume that AI advances will lead to more cancer research and diagnostic tools that enable earlier and more accurate diagnoses from tissue biopsies and better guidance on therapies for patients.   

—Donna Marie Pocius

Related Information:

How AI Improved Breast Cancer Detection by 20%

Artificial Intelligence-Supported Screen Reading versus Standard Double Reading in the Mammography Screening with Artificial Intelligence Trial (MASAI): a Clinical Safety Analysis of a Randomized, Controlled, Non-Inferiority, Single-Blinded Screening Accuracy Study

AI Can Detect Breast Cancer as Well as Radiologists, Study Finds

AI-Supported Mammography Screening is Found to be Safe

European Breast Cancer Guidelines

AI Use in Breast Cancer Screening as Good as Two Radiologists, Study Finds