Category: Health

Health insurers are beginning to adopt AI to support prior authorization decisions. But is this a good thing? Experts weighed in during a panel discussion held by KFF on Thursday.

One panelist said she has some questions about the use of AI in prior authorization, and added that there should be more transparency on this topic and how often prior authorization requests using AI are overturned.

“I think that as we see the use of AI increase, one question we have is, what’s the data that’s going into these algorithms? What data are these algorithms based on? Are they the most current data? Do these algorithms include old studies that may not reflect the best medical knowledge that we have right now? How often are they being updated? Are they being encouraged to deny care, at least at the first level?” said Anna Schwamlein Howard, principal of policy development at the American Cancer Society Cancer Action Network.

However, there has recently been more scrutiny of the use of AI in healthcare, which is a good thing, according to Kaye Pestaina, vice president and director of the Program on Patient and Consumer Protection at KFF. She noted that just last week, there was a Senate hearing on AI in healthcare.

Another panelist echoed the need for transparency when it comes to AI in prior authorization. However, he noted that AI and newer technologies also have the opportunity to improve and speed up the prior authorization process.

“We talk about cancer, it takes over four weeks to get in to see an oncologist or radiation oncologist today, and I hate to think that part of that delay is the result of people having to deal with prior authorization. So any decrease in the latency period of getting people treated is an important thing. And I think as long as you’ve got the transparency and you can understand what these algorithms are doing, then I think it’s potentially a very important improvement overall in the process. I wouldn’t be afraid of it,” said Dr. Troyen Brennan, adjunct professor of health policy and management at Harvard T.H. Chan School of Public Health. Brennan is also a former executive at CVS Caremark and Aetna.

Dr. Fumiko Chino, a radiation oncologist at Memorial Sloan Kettering Cancer Center, said that she welcomes “our new computer overlords with some caveats.”

“We know that datasets are very flawed and that for example, marginalized populations are much more likely to have undocumented stage or they may be missing key elements from their EMR notes that would lead to barriers and therefore may disproportionately face denials,” Chino said. “Then you’ve trained a machine based on a dataset that is essentially racist. I think that’s ultimately what we have to fight against.”

How will the use of AI in prior authorization affect patient trust? Schwamlein Howard noted that the average patient isn’t thinking about this.

“They’re focusing on getting better,” she said.

Photo: Piotrekswat, Getty Images

Pharmacy chains across the country are facing disruptions due to a cyberattack on Change Healthcare, a Nashville-based company that processes patient payments for healthcare organizations.

Change Healthcare is owned by Optum, a subsidiary of insurance giant UnitedHealth Group. On its website, Change Healthcare says that it manages 15 billion transactions per year and is the country’s largest commercial prescription processor. 

On Wednesday, Change Healthcare discovered that an unauthorized party had gained access to some of its IT systems, according to a public filing UnitedHealth made with the Securities and Exchange Commission. The company immediately isolated the impacted systems from other connecting systems once it had learned of the incident, the filing stated. 

As of Friday afternoon, Change Healthcare’s systems are still offline.

UnitedHealth said it believes the cyberattack is specific to Change Healthcare and that all other systems across its enterprise are operational. 

The network interruption is affecting business operations for all military pharmacies across the world, as well as some retail pharmacies across the U.S., including CVS.

There is no indication that CVS’ systems have been compromised, and the pharmacy chain has business continuity plans in place to minimize the disruption of service, Mike DeAngelis, CVS’ executive director of corporate communications, wrote in a statement sent to MedCity News.

“We’re continuing to fill prescriptions in our pharmacies, but in certain cases, we are not able to process insurance claims, which our business continuity plan is addressing to ensure patients continue to have access to their prescriptions,” DeAngelis stated.

Walgreens spokesperson Jen Cotto told MedCity News that “the vast majority” of the company’s prescriptions are not being impacted by the cyberattack. 

“For the small percentage that may be affected, we have procedures in place so that we can continue to process and fill these prescriptions with minimal delay or interruption,” Cotto wrote.

In response to the cyberattack, the American Hospital Association urged all healthcare organizations to “consider disconnection from Optum until it is independently deemed safe to reconnect.”

In its filing with the SEC, UnitedHealth stated that the unauthorized party that gained access to its systems was a “suspected nation-state associated cyber security threat actor.” The U.S. federal government states that nation-state adversaries “pose an elevated threat” to national security, including China, Russia, North Korea and Iran. Cybercriminals from adversary countries may use critical industries — like healthcare — as a target when waging cyberattacks against the U.S., according to the Cybersecurity and Infrastructure Security Agency.

Javvad Malik, lead security awareness advocate at cybersecurity firm KnowBe4, told MedCity News that the cyberattack on Change Healthcare “serves as a stark reminder” of the ever-present cyber threats facing the healthcare sector.

“This situation underscores the necessity for transparency in the aftermath of cyber incidents, as well as the ongoing need for investment in cybersecurity defenses, robust processes and staff security awareness and training to reduce the risk of such attacks,” he wrote in a statement. “The healthcare industry continues to be a prime target for cybercriminals — it’s crucial that healthcare providers not only react effectively to threats but also proactively work to fortify their systems against future attacks.”

Photo: ValeryBrozhinsky, Getty Images

GSK and Vir Biotechnology struck up their influenza R&D collaboration three years ago, aiming to build on a respiratory drug relationship forged at the start of the Covid-19 pandemic. The British pharmaceutical giant ended the Covid alliance last year. Now the influenza partnership is winding down too.

The two companies have terminated their research collaboration on Vir’s antibodies for influenza, Vir said in its report of fourth quarter and full year 2023 financial results on Thursday. San Francisco-based Vir retains rights to these antibodies and is now free to seek other partners to advance their development.

The end of the influenza collaboration follows the Phase 2 failure of one of the partnered programs, VIR-2482. This antibody, which came from Vir’s proprietary antibody discovery platform, is designed to target a region on the neuromindase protein found on the surface of both influenza A and B strains. A mid-stage clinical trial was evaluating VIR-2482 for the prevention of seasonal influenza A illness. Last July, Vir reported preliminary results showing the antibody did not meet either primary or secondary efficacy goals of the trial. In its report of financial results, Vir said it expects a full analysis of the trial data will publish in a scientific journal in the second quarter of this year.

Leerink Partners analyst Roanna Ruiz wrote in Friday research note that the termination of the alliance makes sense, given the Phase 2 failure of VIR-2482. But she added that Vir executives said they are pursuing partnerships for their next-generation influenza programs, which span antibodies and antibody drug conjugates.

VIR-2981, an antibody drug candidate for both influenza A and influenza B, is one of the programs Vir said it expects will have an investigational new drug application filed with the FDA in the next 12 to 24 months. The company is also developing VIR-2482 as a prophylactic for influenza A. This antibody targets hemagglutinin, a protein on the surface of the influenza virus. Vir said lab test results show that this antibody has been able to cover all major strains influenza A strains since the 1918 flu pandemic.

When GSK and Vir began working together in 2020, the focus was Covid-19 drug R&D. The pharma giant made a $250 million equity investment in its new partner to begin that partnership, which yielded the antibody drug sotrovimab. Though the drug, brand name Xevudy, landed FDA authorization during the pandemic, the FDA later withdrew that regulatory status as the drug proved ineffective against the omicron strain.

The influenza partnership began in 2021 with GSK paying Vir $225 million up front and increasing its equity stake by $120 million. Vir stood to receive up to $200 million more upon the achievement of milestones.

Vir’s internal pipeline includes a drug candidate in Phase 2 testing for chronic hepatitis delta and another program in Phase 2 testing for chronic hepatitis B. VIR-1388, a T cell vaccine for preventing HIV, is in Phase 1 testing. Vir’s Covid-19 R&D is also continuing without GSK. VIR-7229 is a next-generation Covid antibody that Vir says is AI-engineered to have increased potency, breadth, and resistance to viral escape. The company expects to file the regulatory paperwork later this year to support evaluating this antibody in a Phase 1 clinical trial.

Vir reported having $1.6 billion in cash, cash equivalents, and investments as of the end of 2023.

“Our financial strength allows us to fund multiple clinical programs through major inflection points while enabling the flexibility to invest in external innovation opportunities,” Vir CEO Marianne De Backer said in a prepared statement.

Image by Flickr user quapan via a Creative Commons license

Join MedCity News and nearly 300 healthcare investors, startups, and innovative-minded executives in Chicago at the Ritz Carlton on May 21-22 for MedCity INVEST 2024. The conference is the premier boutique healthcare investment event in the U.S.  Equal parts networking and curated panels covering the latest trends in healthcare investment, MedCity INVEST 2024 is the ideal event to discuss healthcare funding with investors looking for investment opportunities.

Space is limited. Secure your spot today to attend!!

Photo: phive2015, Getty Images

Perelel, an OB/GYN-founded vitamin company, pledged $10 million to support women’s health research and close gaps in maternal health, the company announced Tuesday.

Los Angeles-based Perelel offers targeted vitamin and supplement packs to support women throughout their reproductive health journey. For example, it has a conception support pack, a first-trimester prenatal pack, a second-trimester prenatal pack, a third-trimester prenatal pack and a motherhood pack. These packs are all about $50 a month for consumers. It also sells products for sleep support, hormonal balance and other areas.

The company’s $10 million pledge comes in the form of product donations and funding grants and will go to the Magee-Womens Research Institute and the Good+Foundation through 2027. The Magee-Womens Research Institute is a U.S. research foundation that is focused on women’s health and reproductive biology. The Good+Foundation is a nonprofit that pairs tangible goods with under-resourced fathers, mothers and caregivers. 

For the most part, Perelel is providing its product donations to the Good+Foundation and its funding grants to the Magee-Womens Research Institute, though Magee may also receive some product donations, according to Victoria Thain Gioia, co-CEO and co-founder of Perelel. The startup and Magee are still planning what research projects the funds will go toward, but it will be focused on maternal and reproductive health, Thain Gioia said.

The company has already provided $2.5 million in product donations since its launch in 2018, so the pledge is similar to what it’s already been doing, Thain Gioia said. She added that Perelel is using the pledge as an “opportunity to advocate about the large women’s health gap and the needs of women right here in the U.S. and these bigger problems in our healthcare system in maternal health.”

There is a desperate need for more women’s health research. In 1977, the Food and Drug Administration chose to exclude women of childbearing potential from clinical research studies. This lasted for about 20 years. It wasn’t until 1993 that Congress passed the National Institutes of Health Revitalization Act, which required women and people of color to be included in research studies. But there’s been improvement, with the White House launching an initiative on women’s health research in November. On Wednesday, the White House committed $100 million for women’s health research. There is also more funding going into women’s health startups, Thain Gioia said.

“I just think overall, there’s more awareness of the need for companies to stand for more and help make broader changes in the private sector. … There’s a lot more that we can do quickly in the private sector across women’s health, and so it’s been great to see how much funding and awareness is going into that space today,” Thain Gioia said.

Perelel also recently announced that it raised $6 million in Series A funding, which it is using to fuel growth, build its team and invest in research and development efforts for its products, Thain Gioia said. The financing was led by Unilever Ventures, Willow Growth and Selva Ventures. In total, the startup has raised $12.1 million.

Photo: StockFinland, Getty Images

Medicare’s April 2023 decision to increase coverage for continuous glucose monitoring (CGM) was a major development for diabetes management. Now, with over a million new eligible beneficiaries and many more to follow this year, CGM usage is expected to grow at a record pace – and primary healthcare providers will play a major role.

Before Medicare’s coverage increase, domestic spending on CGMs was approximately $8 billion. However, that amount is expected to double in the next two years. In addition to the promise it holds for improved diabetes management, the expansion provides opportunities for general practitioners to enhance patient care and to help CGM users establish long-lasting, healthy habits.

The best possible outcomes for people with diabetes using continuous glucose monitors will be driven by sustainable changes made through data-driven, personalized care plans. This means facilitating convenient and efficient touchpoints for patients, when and where they need them, in order to emphasize optimizing treatment regimens and individual behaviors. This continuous model of care builds patient-provider relationships based on trust and communication. Primary care doctors are ideally positioned to make this a reality.

Assistive resources are key to primary care CGM utilization

Endocrinologists have been the early adopters of CGM, based on the greater need for frequent glucose testing in their patient population and greater insurance coverage for type 1 diabetes. However, access to specialists is limited for many patients who would otherwise benefit from CGM use. There are no endocrinologists in 75% of U.S. counties, but primary care is available in 96% of U.S. counties. Facilitating CGM access through primary care providers is key to addressing the rise in eligible patients in the face of limited access to endocrinologists. The question is: Do they have the resources to provide this care?

A recent National Library of Medicine survey designed to measure CGM prescription and awareness was administered to over 600 physicians who mostly specialize in family medicine. Findings revealed that doctors are aware of the benefits of CGM and are open to greater adoption by patients. However, the likelihood of that happening appears to be dependent on the availability of assistive resources to support patients in tasks like analyzing and interpreting their CGM data, and making treatment adjustments based on that data. Over 72% of the survey’s respondents indicated they would be moderately or very likely to prescribe a CGM if utilized by patients in conjunction with education, training or workshops, including consultation on insurance issues. Additionally, 63% would feel more assured if patients participated in a one-time consult with an endocrinologist.

Physicians themselves are often interested in the opportunity to become better acquainted with continuous glucose monitors and to receive comprehensive training on how to use them, which is understandable since many had limited experience with CGMs before the Medicare expansion. Some providers might not have the in-practice software to access patient data and there can be an adjustment period in understanding the ambulatory glucose profile reports that CGM systems generate.

The reports serve as a valuable resource for clinical decision support, offering standardized metrics on glucose levels, trends, and areas of concern. Analyzing CGM data helps clinicians gain a comprehensive understanding of glycemic control during various periods of the day as well as inter-day patterns. These assessments provide valuable information on the impact of medications, food, and activity on blood glucose fluctuations. Armed with this knowledge, healthcare providers can identify patients requiring closer monitoring and can determine optimal times for adjusting insulin or other medications as well as targeted lifestyle changes.

Broader care teams, integration tools, and CGM solutions offer support

Encouraging primary care providers who have committed to scaling their practices’ CGM capabilities is imperative. Fortunately, there are many ways the healthcare community can get involved and do their part to contribute to increased usage of this effective treatment.

Easing doctors’ clinical workflows by integrating CGM data into a practice’s existing infrastructure is key, as it saves time by allowing providers to view data without logging into separate systems. Introducing CGM integration with a SMART platform (Substitutable Medical Applications and Reusable Technologies) that builds on Fast Health Interoperability Resources (FHIR) offers decision support capabilities and saves time by allowing providers to enhance operational efficiency.

When a patient’s information is accessible within an EHR, all care team members can visualize the data in the context of relevant clinical factors, like current medications, the latest laboratory results and vitals, and comorbidities. This is especially important as people with diabetes often seek medical care from multiple doctors who need to be on the same page. A management platform that facilitates integration by streamlining data from CGMs and other connected medical devices minimizes prescribers’ CGM-related tasks, empowers them to make personalized treatment recommendations based on data and contributes to the likelihood of improved patient outcomes.

In addition, SMART on FHIR platforms helps practitioners save money that may otherwise be left on the table. While providers can bill Medicare and many payers in the U.S. for reviewing CGM data, many are not taking advantage of the reimbursement opportunity as time constraints deter them from logging into a standalone CGM data portal to find patients, print reports, and upload files to allow proper documentation of their time in the EHR.

Since many doctors expressed a greater inclination to prescribe CGMs when accompanied by educational opportunities and one-time visits with endocrinologists, initiating such measures represents a great option that can be readily facilitated. Endocrinologists and diabetes care and education specialists (DCES) can support multiple primary care practices by offering telehealth appointments or dedicating a few days per month to visit general practitioners’ offices. Embracing novel ways to provide care is essential, as only 36% of primary care providers have a DCES in their practice, even part-time. By bringing resources to the patient, care teams are increasing the odds of successful CGM utilization.

Training sessions, lectures, and webinars are effective tools to boost physicians’ confidence in working with CGMs. Last year, a training program created by clinical pharmacists and implemented in family medicine residency clinics yielded positive results. On knowledge-based assessments, the 21 primary care physicians who participated scored an average of 20.35% before the program and 90.48% at its conclusion.

Now more than ever, enhancing primary care practices to include CGM capabilities is a crucial goal requiring the support and involvement of the broader healthcare community. Providing the best possible care for the influx of new users driven by Medicare’s updated coverage requires convenience, expanded access to educational opportunities, and telehealth visits. The active participation of endocrinologists and diabetes care and education specialists – along with the integration of CGM data into existing clinical workflows and EHRs – improves care coordination and user experiences. Embracing these and other innovative strategies will pave the way for a more effective and comprehensive approach to CGM utilization in primary care settings.

Photo: noipornpan, Getty Images

Novavax isn’t in a good financial position to be refunding money to customers, having gone through a cost-saving restructuring amid flagging sales of the Covid-19 vaccine that is its only revenue-generating product. But arbitration is uncertain, so rather than roll the dice and risk a huge payout if the dispute resolution does not go its way, the company has agreed to pay Gavi, the Vaccine Alliance, as much as $475 million over the next five years to settle a squabble over a $700 million purchase agreement.

Like other Covid-19 vaccine makers, Gaithersburg, Maryland-based Novavax supplies its vaccine under advance purchase agreements. Government bodies and health organizations such as Gavi make upfront payments to secure vaccine supply. Novavax uses that money to support manufacturing and distribution of its vaccine. The company considers these upfront payments nonrefundable.

Gavi paid $350 million up front under its 2021 advance purchase agreement with Novavax, according to the vaccine maker’s financial reports. After the vaccine secured an emergency use license from the World Health Organization in early 2022, Gavi paid Novavax another $350 million.

As a protein-based vaccine that can be stored at standard refrigerator temperatures, Novavax’s vaccine, marketed in some regions under the name Nuvaxovid, is a more viable choice for parts of the world that lack the infrastructure to support the ultra-cold chain requirements of messenger RNA-based vaccines. The Gavi agreement covered the purchase of 350 million vaccine doses. By mid-November 2022, Gavi had only ordered about 2 million doses, Novavax said. The company sent Gavi a termination notice.

Gavi countered by sending Novavax written notice that it was terminating the agreement, contending the company breached the deal. In addition, Gavi said it is entitled to a refund, minus what has been credited for binding orders placed for Gavi’s Covid-19 Vaccines Advance Market Commitment (COVAX), which was established to secure Covid-19 vaccines for low- and middle-income countries.

Early last year, Gavi filed a demand for arbitration. A hearing at the International Court of Arbitration was scheduled for July. The settlement announced Thursday terminates the original purchase agreement and brings the arbitration to a close. The new agreement calls for Novavax to pay Gavi an initial $75 million. In addition, Novavax must pay $80 million each year through 2028, deferred payments that will total $400 million. However, the amount Novavax pays out each year could be reduced by Gavi purchases of vaccines for supply to low- and middle-income countries. In the event that vaccine demand spikes, the settlement grants Gavi an additional vaccine credit of up to $225 million that may be applied to sales of Novavax vaccines for supply to low-income and lower middle-income countries that exceeds the $80 million deferred payment amount in the years covered by the pact.

In the joint news release announcing the settlement, Novavax President and CEO John Jaocbs said the agreement gives both parties “the ability to continue to work together toward our shared mission of ensuring equitable access to safe and effective vaccines.” Meanwhile, Gavi CEO David Marlow said the agreement allows his organization to keep focus on goals that include providing Covid-19 vaccine access to those in lower-income countries.

“It is good for global immunization, for countries and for healthy manufacturing markets,” Marlow said.

All Covid-19 vaccine manufacturers are experiencing slumping demand for their shots, but as a late-comer to the market, Novavax never experienced the revenue highs achieved by makers of the messenger RNA-based vaccines. In the nine months ended Sept. 30, 2023, the company reported $279.9 million in product sales, down nearly 78% compared to the same period in 2022. Of that total sum, $218.3 million came from outside of the U.S. and Europe.

On Feb. 28, Novavax is scheduled to report 2023 financial results for the fourth quarter and full year.

Photo: Nathan Howard/Bloomberg, via Getty Images

Like many physician specialties, radiology is experiencing a labor shortage driven by burnout and an aging workforce. That is manifesting in various ways across the world — either as higher cost for reading images, long turnaround times for reporting, or simply a complete lack of services. 

Amid this troubling dearth of workers, radiology departments are turning to AI tool s to tackle burnout, decrease clinical workloads and reduce backlogs. However, the pace of this AI adoption is sluggish.

There are hundreds of companies developing AI solutions to help automate workflows for these radiologists and augment their care — but with these clinicians battling burnout at such a high rate, there isn’t enough time to explore, choose, validate and implement the tools available. Earlier this month, a San Francisco startup seeking to address this problem through its radiology AI marketplace secured $6 million in seed funding. 

This week, MedCity News spoke with the startup, named CARPL, as well as two of its provider customers to learn more about its approach to accelerating the adoption of AI in radiology. 

Recognizing the need for a marketplace

Of the 700 AI-based applications approved by the FDA, about 80% are related to radiology, CARPL CEO Vidur Mahajan noted. There are two main reasons for this — the immense need for technology to accelerate workflows in the field and the democratization of high-quality data to train healthcare algorithms, which has made the creation of AI tools “extremely easy,” he said.

Mahajan founded CARPL in 2021. Before launching the startup, he used to run his family’s India-based chain of radiology centers. There, Mahajan managed the company’s research group, which was called the Center for Advanced Research in Imaging, Neurosciences a Genomics (CARING). He noticed that the radiology field was slow to test and deploy AI, so he started working on a software called the CARING Analytics Platform, which later came to be called CARPL, he explained.

“There is a massive shortage of radiologists globally, which is leading to problems related to access, affordability and quality of radiology services. To address this shortage, hundreds of AI companies have been developing applications which seek to automate niche aspects of radiologists’ work. Unfortunately, healthcare providers are unable to navigate this complex ecosystem of niche yet overlapping application developers,” Mahajan remarked.

He called CARPL a “middle layer” that serves as a single data channel and procurement system for radiology AI applications — all on one user interface.

How it works

The marketplace is designed to give providers one place where they can find, assess and safely integrate radiology AI solutions into their clinical workflows. Over the past two years, CARPL has onboarded more than 50 AI developers, resulting in more than 100 AI applications on the marketplace. 

The tools on CARPL’s platform aim to both alleviate radiologists’ burnout and help them practice at the top of their licenses. They serve as a second pair of eyes that can aid radiologists by flagging subtle, hard-to-catch lesions or other abnormalities that might have otherwise been missed, Mahajan said. 

Some of the vendors with tools on CARPL’s marketplace include Qure.ai, Lunit, AZmed, Gleamer, Avicenna and Radiobotics. Their tools help radiologists better read a variety of images — such as X-rays, CT scans, MRIs and mammography slides — and automate time-consuming, tedious tasks through their radiology-specific software for documentation and reporting. 

Each healthcare AI application has its own unique technical architecture, Mahajan noted. He said that CARPL’s platform addresses this by harmonizing and standardizing all the tools on its platform into a single user-interface, rather than multiple disparate systems. 

Mahajan also highlighted the importance of CARPL’s AI validation and monitoring capabilities. He said these features help set the company apart from other healthcare AI marketplaces, such as Blackford or SymphonyAI.

“An AI system, just like a human, needs to be interviewed prior to being let loose on patients,” Mahajan declared.

CARPL’s platform gives providers tools to validate an AI application before implementing it into their clinical workflows. These tools help providers determine if the solution in question is right for their patient base, as well as helps them set guardrails around when AI should be used. The platform also continually monitors the performance of AI applications and alerts providers when a tool’s accuracy or effectiveness has fallen, Mahajan explained.

Some of CARPL’s customers include Massachusetts General Hospital in Boston, Radiology Partners in Los Angeles, University Hospitals in Ohio, Albert Einstein Hospital in São Paulo and Clinton Health Access Initiative in Singapore. The company charges its customers a fixed monthly subscription fee for access to its platform, as well as a usage fee based on the number and nature of scans that are run through the platform, Mahajan stated.

Why customers have to say

Dr, Leonardo Bittencourt — an associate professor of radiology and the vice chair for innovation at University Hospitals and Case Western Reserve University in Cleveland — is one of the radiologists using CARPL’s marketplace. 

He said his employer was drawn to CARPL’s platform because it is a single platform that has the ability to manage datasets, annotate data, assess and validate AI tools, and implement AI solutions into clinical workflows.

“Our program is centered in industry-academic collaborations, which rely on data enablement and annotations, as well as ground-truthing by domain content experts,” Dr. Bittencourt explained. “CARPL provides an environment where such initiatives can happen and be put to test.” 

Ground-truthing refers to the process of verifying information obtained through remote sensing by physically visiting or examining the site in question.

It is a “notorious challenge” for hospitals to have to manage the sourcing, validation, deployment and monitoring of every single AI solution connected to their radiology information systems, he added. In his view, CARPL’s marketplace has eliminated this obstacle, as well as exposed radiology departments to a broader mix of solutions.

Dr. Charlene Liew — director of innovation in radiology at SingHealth, part of the Singaporean national health system — is another example of a radiologist benefiting from CARPL’s marketplace. 

In an emailed message, she highlighted the fact that the platform has been able to expedite the AI validation process at SingHealth, which has helped minimize strain on the country’s radiology workforce. She recommended the platform for use at other provider organizations.

“Using a validation platform such as CARPL will help to speed up the deployment of AI models into mainstream use, as well as enable the value of AI to be realized,” she wrote.

Similarly, Dr. Bittencourt of Case Western recommended the platform to other providers as well, underscoring the marketplace’s ability to accelerate pace of AI tool integration, simplify validation and provide ongoing AI monitoring services.

Both doctors agreed that the quicker validated radiology AI gets incorporated into clinical workflows, the quicker radiologists can provide patients with the level of care they deserve.

Mahajan stated that the main goal of CARPL is to save clinicians time and elevate their quality of care. He noted that shorter reporting turnaround times and the ability to triage important scans over normal ones leads to quicker treatment — and thereby better outcomes.

Photo: Hemera Technologies, Getty Images

Clinical trials often suffer from a lack of participant diversity, resulting in findings that may not fully represent the eventual treated patient population. This issue has improved only modestly in the last decades. Recognition of this limitation has coalesced recently with the Food and Drug Association’s recommendations for diversity action plans; however, sponsors and researchers are tasked with determining how to address prior limitations and recruit more diverse patient populations.

Clinical trials play an essential role in bringing forward safe and effective medical treatments and technology, but, of the less than 5 percent of the U.S. population participating in clinical research, 75 percent of these participants are of European descent. A recent analysis of U.S. cancer clinical trials found that 48 percent had no Hispanic or Latin American representation, and only 58 percent included participants who were Black. In addition, in their site selection and implementation, clinical trials may disregard other factors that can impact disease burden and prevalence, such as geographic location.

Clinical trial sponsors should be empowered to include more diverse and representative patient populations and there is a path forward for better democratization of clinical trials and research.

To break down barriers to clinical trial access, accelerate diverse participation in clinical trials, and ensure more inclusive and representative trial results, researchers can implement the following five strategies:

#1: Improve inclusion by collecting and analyzing social determinants of health data

Many clinical trials do not focus on underserved populations, and very few individuals in these cohorts are recruited to participate in clinical trials. Factors, such as education level and urbanicity, affect the odds of a participant even receiving an invitation to participate in a clinical trial.

Data from these underrepresented populations, including real-world data and SDoH data, exist and more can be collected. These data hold amazing potential to improve the lives of patients in the rare disease space, develop novel therapeutics, build care pathways, advance adherence, improve the safety and efficacy of healthcare, and develop medical devices, by surfacing insights and providing the foundation for more inclusive clinical trial design and recruitment. Ideally, every new treatment or therapy would be developed with the full inclusion of the populations impacted.

More clinical institutions are collecting SDoH data through interviews and surveys. This information, however, is typically captured in unstructured clinical notes or open-ended survey responses (which leads us to the need for a common healthcare data language – see #3). To fully understand how SDoH influences health and disease treatment response, such data must be collected and standardized in a way that is interpretable by health systems, public health agencies, and research organizations. Most importantly, these data should be analyzed in the broader context of clinical trial planning and implementation to ensure that the right populations are included in drug and medical device trials and the right factors are considered in determining trial outcomes.

#2: Combat data infrastructure challenges

We developed a healthcare ecosystem that connects providers and life science companies as a response to my frustrations as a physician-researcher. I routinely observed how difficult it was to ensure we included all patients, making sure the research truly represented all of our communities. In my mind, the key to resolving this lay in better data standardization and interoperability.

I still observe the healthcare industry struggling with the challenges of siloed data and impediments to data sharing. The broader life sciences community can benefit from access to provider data to identify study populations and determine burden and disease prevalence in different populations. EHRs used in routine care can be further leveraged to supplement clinical trial data and enable research at the point of care. Lowering the barrier to data collection could broaden study types, leading to greater patient diversity in trials. A robust healthcare data ecosystem can help maintain the data capture and flow necessary for democratization.

#3: Create a common data language across stakeholders

Another factor holding back clinical trial democratization and trial accessibility is the absence of a “common language” for data. There is not yet widespread adoption of data extraction from the medical record into one common language that’s accessible to diverse sectors. Various data standards are helping, such as HL7, LOINC, etc., but adoption is slow and inconsistent, and stringent implementation is lacking. Plus, these standards do not address the wealth of data captured in the unstructured sections of the EHR, including the above-mentioned SDoH surveys. Organizations such as the Clinical Data Interchange Standards Consortium are working globally to improve these standards and are worth following to keep up to date with their efforts. Right now, there is no standard by which valuable but disparate sources of healthcare data are automatically integrated in a way that a researcher can query patient demographics and history to support clinical trial engagement. Provider organizations who want to engage in trials do not have all the patient data accessible to easily match their patients to trials. This is a reason why we built a data platform that fuels partnerships that drive patient care.

#4: Leverage clinical data outside the EHR to break down barriers and facilitate access for underrepresented communities

Up to now, many clinical trials have relied on access to dense population centers that accompany large health systems, such as academic medical centers. Study design and participant outreach are limited to these centers’ patients and exclude the broader community and underrepresented patients. Inclusive clinical trials could be conducted outside of large medical centers to ensure that a participant’s genetics, background, and personal experiences are taken into consideration when studying a new treatment’s efficacy and safety. Casting a wider net for trial participant populations and ensuring they stay engaged and enrolled in the trial through completion requires specific personnel, capabilities, and resources for appropriate trial planning, analytic insights, representation, and participant engagement.

A good first step in engaging underrepresented populations is for study sponsors to analyze robust clinical data sets to inform the development of more accurate and broader recruitment, participation, and retention strategies. This can help ensure a more inclusive population is invited to participate in trials and to facilitate the appropriate physicians’ engagement in the trial.

#5: Involve community organizations and businesses in clinical trial support and ensure these locations have the resources and capabilities to successfully conduct clinical trials

Community researchers, specialty practice clinical sites, and local pharmacies can play a pivotal role in clinical trial education and access. With a broader range of recruitment locations comes a more diverse participant cohort, and the resulting treatment innovations are more inclusive. These organizations require assistance, however, to optimize data collection, normalization, and aggregation. This means building out data networks and infrastructure in underrepresented areas, such as rural geographies and community health centers. With this assistance, researchers and study sites are empowered to identify and connect with more participants and conduct more comprehensive analyses.

To increase trial participation, this outreach should extend to community members where they live and work and through smaller local health practices. Some pharmacies, such as Walgreens, are educating the populace about the importance of clinical trials and the opportunities they represent. With only 59 percent of the U.S. population indicating an awareness of clinical trials and how they work, community-based practices and pharmacies have a unique opportunity to drive inclusivity.

The current lack of representation in clinical trials remains distressing and impedes health equity. Without taking specific steps to improve trial diversity – such as promoting greater community involvement, developing the right data ecosystem, building robust inclusive data sets, and using a shared clinical data language – advances in inclusive treatments will continue at a snail’s pace.

Photo: Irina Devaeva, Getty Images

Categories

CategoriesSelect CategoryCare ManagementClaims & Contract ManagementCollections OptimizationComplianceData and AnalyticsFeaturedHealthcare MarketingIdentity ManagementPatient AccessPatient EngagementPatient ExperiencePrice Transparency

Archives

Archives
Select Month February 2024 January 2024 December 2023 November 2023 October 2023 September 2023 August 2023 July 2023 June 2023 May 2023 April 2023 March 2023 February 2023 January 2023 December 2022 November 2022 October 2022 September 2022 August 2022 July 2022 June 2022 May 2022 April 2022 March 2022 February 2022 January 2022 December 2021 November 2021 October 2021 September 2021 August 2021 July 2021 June 2021 May 2021 April 2021 March 2021 February 2021 January 2021 December 2020 November 2020 October 2020 September 2020 August 2020 July 2020 June 2020 May 2020 April 2020 March 2020 February 2020 January 2020 December 2019 November 2019 October 2019 September 2019 August 2019 July 2019 June 2019 May 2019 April 2019 March 2019 February 2019 January 2019 December 2018 November 2018 October 2018 September 2018 August 2018 July 2018 June 2018 May 2018 April 2018 March 2018 February 2018 January 2018 December 2017 November 2017 October 2017 August 2017 July 2017 June 2017 May 2017 April 2017 March 2017 December 2016 November 2016 August 2016 May 2016 April 2016 March 2016 April 2015 February 2015 January 2015 November 2014 September 2014 July 2014 March 2014 February 2014 December 2013 October 2013 September 2013 August 2013