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—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, highlight expert interviews, and keep you current on what’s moving the industry. Let’s get into it.

On this episode, we’re spotlighting our three most-viewed articles from the past week—covering regulatory shifts, vaccine funding changes, and the future of digital transformation in clinical trials.

Recent Complete Response Letters to Replimune and Capricor

 are sending a clear signal: the FDA is turning up the heat on clinical trial design. In both cases, the agency cited inadequate or incomplete trial structures—surprising the sponsors despite earlier communications. Industry leaders warn this marks a shift toward heightened oversight that could impact everything from patient recruitment to timelines. The FDA’s own transparency push, including publishing over 200 CRLs from recent years, reinforces the message: tighten your study designs, document every interaction, and expect less leniency in late-stage approvals.

the US Department of Health and Human Services is winding down mRNA vaccine work under BARDA

, canceling 22 contracts worth $500 million. The move shifts funding toward vaccine platforms that officials say are safer and more resilient to viral mutations. Programs at Emory University, Tiba Biotech, and several industry partners are being terminated or scaled back, with some late-stage projects allowed to finish. The decision also halts funding for Moderna’s H5N1 bird flu vaccine, despite positive early trial results. Critics warn the cuts could slow progress in critical vaccine research and disproportionately impact trials involving minority populations.

digital tools and AI are rapidly transforming clinical research

—accelerating data collection, streamlining processes, and expanding patient engagement options. But with innovation comes complexity. The author of this article highlights five priorities for navigating this shift: strengthening data governance, creating trusted AI frameworks, implementing risk-based processes, upskilling clinical teams, and fostering cross-industry collaboration. The takeaway: technology should enable better science, not dictate it.

For more on this and other developments in clinical research, visit us at 

Podcasts

In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed stories of the previous week with a look into the FDA’s heightened scrutiny of trial design, the wind-down of federal mRNA vaccine programs, and how digital innovation is reshaping the clinical research landscape.

ACT Brief Episode 2: FDA Oversight, Vaccine Funding Cuts, and the Digital Future of Clinical Trials

, tackling a topic that’s resurfacing in troubling ways: placebo-controlled vaccine trials.

Secretary of Health and Human Services, Robert F. Kennedy Jr., is pushing for more placebo-controlled vaccine trials—framing it as a return to scientific rigor. But as the authors explain, that framing ignores both medical ethics and history.

Once a vaccine has been proven safe and effective, it is no longer ethical to withhold it in a clinical trial setting. Giving participants a placebo when a working vaccine exists isn’t just unnecessary—it’s dangerous. That principle is embedded in both the Common Rule and FDA regulations, which require minimizing risk and maximizing benefit in human studies.

The idea of withholding treatment in the name of science has a dark past in the US—most notoriously, the Tuskegee syphilis study. That wasn’t just unethical. It was lethal.

Kennedy’s recent “Make America Healthy Again” report suggests bringing back placebo arms even for standard childhood vaccines. If implemented, this would violate long-established protections for research subjects and open the door to trials where participants—especially children—are knowingly exposed to preventable illness.

Alarmingly, this isn’t just hypothetical. In May, the FDA approved a Phase IIII placebo-controlled trial for Novavax’s COVID-19 vaccine in low-risk adults. That’s a trial in a population where safe vaccines already exist. It’s a shift away from science-driven ethics and toward politically motivated disruption.

The deeper danger? A chilling effect on vaccine innovation. Once trial participants understand they may receive no protection against disease, enrollment will plummet. And if children are involved, expect outrage.

This isn’t transparency. It’s regression. And in clinical operations, we know: ethical trial design isn’t a barrier to good science—it is good science.

In this pilot episode of the Applied Clinical Trials Brief, we examine the renewed push for placebo-controlled vaccine trials in the US, why experts warn it violates core ethical standards, and how these proposals could jeopardize both participant safety and future innovation.

ACT Brief Episode 1: Placebos, Politics, and the Ethics of Vaccine Trials

A 2025 survey highlights growing momentum for multi-indication drug development, with opportunities in innovative trial design, targeted patient selection, and real-world evidence to speed label expansion.

Embracing Proactive Multi-Indication Development for Metabolic Therapies

New statistical frameworks such as net treatment benefit offer a multidimensional approach to evaluating efficacy, safety, and patient-centered outcomes in oncology trials.

Rethinking Oncology Trials With a Statistical Methodology That Puts Patients First

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors

A new global report finds that clinical research teams are making progress but still lack the skills and tools needed to keep pace with growing trial complexity and emerging technologies.

 Empowering the Workforce of the Future: The Trends and Training That Will Drive the Future of Drug Development

Results from the Phase III FORTITUDE-101 trial showed that bemarituzumab combined with chemotherapy demonstrated both statistical significance and clinical relevance in previously untreated patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer who are FGFR2b-positive and HER2-negative. 

Amgen’s Bemarituzumab-Chemotherapy Combination Significantly Improves Overall Survival in Unresectable Locally Advanced or Metastatic G/GEJ Cancer

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, shares practical ways clinical teams can strengthen trial protocols for expedited programs—such as incorporating control groups where possible, leveraging synthetic and real-world data, and adopting adaptive trial designs to reduce regulatory risk.

Future-Proofing Trial Protocols to Avoid CRLs

, Meri Beckwith, Co-CEO, Lindus Health, discussed the evolving perception of breakthrough designation amid the FDA’s recent 

 issued to Replimune and Capricor. He emphasized that breakthrough designation does not necessarily guarantee approval, but offers quicker decision access and investor signaling. Beckwith also stressed the importance of agility in trial design, advocating for adaptive trials and control groups where ethical. To mitigate regulatory unpredictability and avoid costly CRLs, he highlighted the need for future-proofing trial protocols with adaptive randomization and synthetic control groups.

ACT: What changes would you recommend clinical teams make now to future-proof trial protocols—especially when pursuing expedited programs—to avoid costly CRLs down the line?

It's pretty obvious, just given the FDA’s comments here, but control groups where possible. Now, obviously, I do believe that a control group in Replimune’s case would have been unethical, and I think you'd struggle to get an IRB or an ethics committee to sign off on anything like a kind of a conventional RCT with a one-to-one randomization ratio. Now, there are constantly-improving kinds of options around match placebo controls often using AI to create synthetic data, or using a growing trove of real-world evidence to create that match control. I don't believe Replimune included that. That is a relatively low-cost option to try and include, so that is something that sponsors could look into, but it's very different in a space like cardio metabolic or type 2 diabetes, a more chronic condition, it would be very appropriate to include a control group. But again, there are also options which technology enables for us now, like adaptive trials, where you could have an adaptive randomization ratio and start with a one-to-one ratio, and as you notice an effect on the control group, reduce the number of participants who are randomized onto a placebo. Using technology now, you can do that without unblinding the study teams to the results, so those options do exist. Again, relatively low-cost ways of ensuring or preventing these CRL letters. If I were a clinops leader, I'd look into them. It's something that we've been doing for some of our sponsors now. Certainly, we hope that in the near future, every clinical trial will be adaptive by default, and I think there's really no reason not to.

Videos

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, discusses whether recent trial design rejections signal a broader shift in FDA expectations or simply reflect changes in individual reviewers, emphasizing that current unpredictability may be more situational than systemic.

Is FDA Trial Design Scrutiny Increasing or Just Less Predictable?

ACT: Do you think the growing scrutiny around trial design is a sign of regulatory unpredictability, or are we seeing more transparent expectations from the FDA that just haven’t been operationalized effectively yet?

I’m not sureI'd quite say that there is more scrutiny, or there's a pattern of more scrutiny, on trial design. I do think in this case, it just seems to be kind of like a personally driven issue with a few kind of personalities inside the FDA. Having said that though, maybe over the next year or two, there's a pretty consistent pattern of the FDA rejecting more studies that aren't controlled or insisting on more robust results, more carefully scrutinizing sample sizes, those kinds of things, remains to be seen. My view is that these decisions, it's just kind of unpredictability, the result of one set of reviewers, maybe transitioning off or out of the FDA, and then a different set of reviewers with a different perspective coming in. That does make me hopeful that this will be an isolated case of just regulatory unpredictability rather than a sort of raising of the bar, but it remains to be seen.

Enhancing Clinical Trial Integrity Through AI and Digital Twin Technologies

, Jon Walsh, founder and chief scientific officer of Unlearn, discussed how AI-designed therapies and digital twin technologies are reshaping the clinical trial landscape. While the fundamental principles of clinical testing remain consistent, Walsh explained that AI-discovered drugs often warrant deeper attention to specific biomarkers and safety signals in early development. He also highlighted how digital twins—virtual models of trial participants—can significantly improve trial efficiency, reduce control group sizes, and enhance the precision of treatment effect estimates. As regulatory agencies like the FDA and EMA begin to offer clear frameworks for integrating AI into drug development, Walsh emphasized the importance of transparency, reproducibility, and interpretability in model design and implementation.

ACT: How do you ensure transparency and reproducibility when using AI and digital twins in clinical research?

One of the key components of the FDA’s seven-star framework is the ability to evaluate and demonstrate that a model appropriately addresses risks and is aligned with its context of use. In practice, this means that when you build the underlying machine learning models that power digital twins, and when you apply them in studies, the development process must be traceable.

You need to fully understand the data that goes into building the model, how the model was developed, and the decisions made throughout that process. Then, when generating digital twins for a trial, you must be able to demonstrate that this generation occurs in a trustworthy, pre-specified manner. For example, the data must exist ahead of unblinding and cannot be used by sponsors to unblind their own trial data. By satisfying certain criteria around the chain of custody and generation of data, you can trust the results of the analysis.

We have worked hard to build software and systems that enable this level of transparency. Another critical component is interpretability. Regulators are rightly concerned about understanding how predictions are made by AI models in drug development. Applying interpretability tools to digital twins—especially those derived from complex models—helps identify which variables are most important, what drives disease progression, and whether the outputs make sense in the overall clinical context.

AI-designed therapies can present unique characteristics in clinical trials compared to traditionally developed treatments, often requiring closer scrutiny of biomarker signals and safety data early on. However, the fundamental process of clinical testing remains consistent. Digital twin technology helps make these trials more efficient and insightful by modeling individual trial participants under standard of care, offering a virtual comparator without needing additional enrollees.

Digital twins work by creating a probabilistic model of how a specific patient would respond to standard treatments over time. Rather than enrolling new participants, sponsors gain deeper insights into existing ones, improving the precision of treatment effect estimates and boosting trial power. In randomized controlled trials, this added statistical confidence can reduce participant numbers or accelerate timelines. In open-label studies, digital twins can serve as virtual control arms, allowing meaningful comparisons when a real control group is not feasible.

Regulatory agencies like the FDA and EMA are providing clear guidance on the use of AI and digital twins in drug development. They emphasize defining the model’s context of use, evaluating its risks, and proving its reliability. The companies building digital twins must ensure model development is transparent, reproducible, and interpretable—tracking how models were built, and which data were used, while safeguarding against unblinding.

Looking ahead, digital twins are expected to become a foundational part of the clinical trial landscape, particularly in neuroscience and CNS trials. They offer the promise of more adaptive, efficient, and patient-centric designs that can accelerate drug development and reduce reliance on traditional control groups, while maintaining—or even improving—the quality and reliability of clinical evidence. As adoption grows, digital twins could reshape how sponsors design trials and regulators evaluate new therapies.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how AI and digital twin technologies are being applied to improve data transparency, ensure reproducibility, and strengthen the reliability of clinical trial outcomes.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, explains why sponsors pursuing breakthrough or priority review designations must maintain rigorous trial design while building organizational agility.

Balancing Speed and Rigor in Accelerated Trial Pathways

ACT: How should clinops leaders balance trial design for accelerated pathways like breakthrough or priority review, while still meeting the FDA’s rising bar for adequate and well-controlled studies?

 I'd go back and say just because you have a breakthrough designation doesn't mean you should treat the trial design process, or approach the trial with any less rigor. I think most people are on board with that. I think that the best thing that sponsors can do in these times of uncertainty with the FDA is to cultivate agility. If the worst happens, and the FDA effectively moves the goal posts on you, and you need to generate more data, cultivate agility in your organization to be able to generate that data or even an entire new study, worst case at a reasonable cost. I think the way I've observed a lot of the industry operates is it's in a very kind of waterfall fashion, where you specify a study design, you agree on it with the FDA, you gold plate it by trying to throw every conceivable mitigation at it, and that makes these studies lengthy and expensive. This is things like 100% SDV, extra-long follow up periods, many, many secondary and exploratory endpoints, and so on. What I think some sponsors could be better served by, is cultivating the agility necessary to be confident in a study design, but then be ready to generate additional data, and do that quickly if need be without this very laborious gold plating process. Ultimately, it's about more shots on goal. I think that's the best way to insulate yourself against the uncertainty.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, discusses recent Complete Response Letters issued to Replimune and Capricor, explaining how shifts in FDA reviewers can affect single-arm trial acceptance, especially in oncology settings where control groups may be deemed unethical.

FDA Review Changes and the Impact on Trial Design

ACT: With both Replimune and Capricor expressing surprise at receiving CRLs, what operational red flags should clinical teams be watching for earlier in the design or submission process?

Yeah, this is a tricky one. I think particularly in Replimune’s case, the FDA seemed to take issue with the fact that it was an uncontrolled study. I've got to say that that's pretty unfortunate, given, obviously the FDA were involved, and Replimune would have cleared that with them. I mean, it's also super common in this space, i.e., non-responders in oncology to run an uncontrolled study, because, arguably, having a control group would be, would be unethical because these people are going to die without treatment. I'm not really sure the clinical operations folks are really at fault here. I know a bit more about the Replimune case than I do Capricor, but in Replimune’s case, the study design had been approved by the FDA. Running a single-arm design is such a fundamental part of the study design, that there's no way that wouldn't have been carefully scrutinized by the FDA at the point at which they discussed the study design with them. I think they more just fell afoul of shifting internal politics at the FDA, and I'd say it's as simple as, with the change in administration, a lot of reviewers have changed. They went from a set of reviewers who were very comfortable with that approach to a different set of reviewers who are less comfortable. I think it's as simple as that. I don't think it's part of a grander shift in policy at the FDA. I think it's just a changing of the guard, and the new guard have a slightly different take on things, and unfortunately, Replimune has fallen foul of that.

In this video interview, Michael Miller, chief operating officer at Quanterix, discusses how biopharma companies—especially smaller biotechs—can leverage platform trials and biomarker-driven accelerated approvals to remain efficient and competitive amid shifting public-private funding dynamics.

Adapting to a Changing Research Funding Landscape

, Michael Miller, chief operating officer, Quanterix, discussed how the clinical research industry is increasingly integrating biomarkers. Biomarkers are particularly beneficial in neurology, where advancements in imaging and blood tests have improved trial outcomes, and in oncology, where multiomic approaches and protein tissue imaging aid in matching therapies to mutations. Synopsis professionals should focus on the biomarker's purpose, technical requirements, and regulatory compliance. Platform trials and biomarkers are also driving accelerated drug approvals. These advancements are crucial for biopharma companies navigating the shift between private and government-funded research.

ACT: With a shift in balance occurring between private and government-funded clinical research, what are some opportunities for biopharma companies moving forward as they navigate this new, challenging landscape?

I can think of a couple areas. One is, in terms of, let's say biotechs or smaller companies, probably not so much large pharma, but participating in platform trials as a way of having a more efficient clinical trial approach. A platform trial is where a particular institution or different institutions will pull money together to be able to recruit patients within a particular disease area. Sometimes it's rare diseases because they're less available and harder to recruit, and then multiple drug companies can come and access that population and do subsets of that population, give them drugs, track their outputs, and the infrastructure is put together by the platform so each company doesn't have to do that lift. That's one example I can think of that can help people be more efficient given the times, and do things like that.

The other relates back to one of the main themes of this discussion, which is biomarkers. In the example I'll cite here is that biomarkers have allowed people to get accelerated approval for drugs that have a breakthrough designation. One example in the neurology area was a blood test for neurofilament light that was used to gain accelerated approval for an ALS drug, so that's an example. That's a technology that Quanterix was involved in, neurofilament light, making that commercializing that assay, but that's a huge gain to where now you have a rare disease, it's very difficult to track clinical outcomes, and here's a biomarker that can show efficacy by giving you a signal of lower levels of neurodegeneration that then can speed going to getting regulatory approval. Again, accelerated regulatory approval, nonetheless, it allows them to get them to market faster and advance the drug.

In this video interview, Michael Miller, chief operating officer at Quanterix, outlines key technical and regulatory considerations for clinical operations professionals integrating biomarkers into studies, stressing the importance of clarity on biomarker purpose and working with qualified assay partners.

What Clinical Ops Teams Must Know About Biomarkers in Trials

ACT: What should clinical operations professionals have top of mind when utilizing biomarkers in trials they’re managing?

I think that the first most important thing to think about in terms of when including biomarkers in a clinical trial is what is the purpose of the biomarker, and the reason why I say that is that that's fundamental to then understanding what are the technical requirements of, let's say, an assay or a technique to measure that biomarker, and then also what are the regulatory requirements around the use of that biomarker. I'll give you an example. We've done some work for customers where we'll be measuring a blood biomarker to help understand who should be enrolled in a clinical trial, and when you use a blood biomarker to decide who might be excluded from a trial, that's considered a medical decision, so this is up to the pharmaceutical companies or the clinops people to decide whether this applies or not, but I'm just giving you an example. That then puts a higher level of regulatory requirement on the validation of the assay, the evidence behind the assay, and its use. A vendor like Quanterix, we routinely do that within our accelerator lab for customers, and so the clinops people should think carefully about, ‘Hey, what is the purpose? How's this going to be used?’ because there may be regulatory requirements. I think you had mentioned earlier about hesitancy. I think this is where it can cause some hesitancy because it sounds complicated, but there's plenty of people who can help customers through that process, as I mentioned, we've done it.

Further that relates to where I've talked about purpose that gets to technical requirements. What's the sensitivity of the assay? How is it validated, the regulatory requirements? Then that then leads you to, ‘Hey, who should I partner with to help me measure this biomarker?’ and again, the regulatory and the technical requirements will help with that selection, because then you're like, ‘Oh, here's what I need to measure. Here's the regulatory framework you need to operate under the quality system, for example.’ If you want to submit your results to the FDA, you need to have custody of sample, data integrity, and auditability of the results, so you want to work with a partner who can provide you that. As I said, Quanterix is one of those partners.

In this video interview, Michael Miller, chief operating officer at Quanterix, highlights neurology and oncology as two therapeutic areas experiencing major advances from biomarker integration, from blood-based diagnostics in Alzheimer’s to multiomic strategies in cancer research.

How Biomarkers Are Transforming Neurology and Oncology Trials

ACT: Which therapeutic areas do you think can benefit the most from having biomarkers in their trials?

I think there's two disease areas that I think are good examples of where biomarkers can have a significant effect. One area where Quanterix has spent a lot of its efforts and had had an impact is on neurology. As an example there, for decades, progress was difficult because there weren't good biomarkers for understanding changes in the brain and then a number of groups developed imaging methods to be able to image amyloid plaques in the brain for Alzheimer's, and then eventually in CSF as well, in terms of cerebral spinal fluid, and then that allowed researchers and in clinical trials to see what is really happening when drugs are given to individuals with those plaques. Now, even more exciting is that in recent years, now there's blood biomarkers, and that's where some of our ultra-sensitive technology has played a role, had been able to further enhance the accessibility of enrolling people in clinical trials that might not have had the opportunity, or reducing the cost of clinical trials, because you can use a blood test to identify somebody who might be appropriate for a trial, as opposed to having to wait for a PET scan or a spinal tap to do these other methods. That's one really good example where biomarkers have undergone an evolution from complex but very good gold standards to something simpler that can then speed the efficiency of a trial.

I think another example is in oncology. We know cancer is a genetic disease, where mutations dominate the behavior of the cancer and the therapies are matched to the mutations, and that's been a mainstay or work where a lot of progress has been made in terms of identifying who's appropriate for a particular therapy, but there's more progress that needs to be made there. I think that's where you're seeing now, going to multiomic approaches, and then using protein tissue imaging, which is what Akoya does, who we recently acquired, can then help with the phenotype, to then further go from the genotype, and then look at the phenotype below that, that further segment populations and really find individuals who will respond to the drugs with a better response rate.

In this video interview, Michael Miller, chief operating officer at Quanterix, discusses how the use of biomarkers is expanding beyond exploratory endpoints to inform efficacy and patient selection, driving improved outcomes and greater efficiency in clinical research.

Growing Excitement Around Biomarkers in Clinical Trials

ACT: Where does the clinical research industry currently stand with biomarker integration? Is it becoming more popular, is there hesitancy around it, excitement, etc.?

I think there is a lot of excitement about biomarkers in clinical trials right now, and a lot of that stems with some of the new uses. Currently, a lot of trials do include biomarkers. Today, many of them can be used for exploratory purposes or exploratory endpoints, but the real action, or the real excitement is around biomarkers starting to be used to understand the efficacy of the drug or to help understand selecting the right patients to be enrolled in a trial for a particular drug. Why is there excitement? Excitement is because that can make the clinical trial outcomes more successful and make the clinical trials more efficient, in terms of you're getting the right patients on the right drug, seeing better efficacy in those patients.

In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, outlines her five-year vision for community-based research, calling for deeper industry alignment, infrastructure expansion, and patient-first design principles.

The Future of Clinical Trials in Community-Based Settings

, Ramita Tandon, chief biopharma officer, Walgreens, discussed the company’s three-year milestone of leading clinical trials. Tandon highlighted several of Walgreens’ initiatives in the space, including how its 8,000+ pharmacy locations are bringing research directly into communities. She emphasized the need for community-based partnerships, cultural competence, and education to empower patients. Looking forward, strategic partnerships will be key in enhancing inclusivity and accessibility, with the ultimate goal of bridging gaps in clinical research and public health.

ACT: Looking ahead, how do you see the role of retail or community-integrated sites evolving in clinical trials over the next five years?

That's a great question. Obviously, Walgreens has played a very pivotal role in shaping the future of clinical trials in the last three years by leading the way to demonstrate, not just simply talk about it, but demonstrate how, if you bring research closer to the patients, they will respond. If you spend the time to educate and empower, you make them comfortable, they will respond. They'll more likely want to participate. We also believe that forging strategic partnerships in the industry is best practice. We recognize that we can't do this alone. It's going to require unlocking, at the local level, as well as the national level, so the industry partnerships, whether it's public and private, will be absolutely pivotal and critical to come to the table to shape the future of clinical research. That collaboration is going to be so absolutely critical. Again, it's with regulatory bodies and other key stakeholders. I think, the success of pharmacy-based clinical trials continues to hinge on the sustained, committed strategies that we've put in place around robust infrastructure investment, intentionality, around community engagement, and we're seeing those collaborative efforts proving to be beneficial, and it allows us to overcome challenges such as that skepticism that we've seen in the industry around participation and then logistical issues. You make it easier for patients to participate because it's convenient. It's easier because there's infrastructure that's put in place to allow a pathway for patients to participate. For us, from a retail perspective, we're going to continue to harness the potential of retail settings as we continue to invest as an organization, but our focus continues to be doubling down on the inclusivity and making sure we're providing comprehensive health care solutions for the patients that we serve across the nation, ultimately enhancing public health outcomes and closing care gaps as we see access as a big issue for patients across the healthcare ecosystem.

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