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1rem

David Nickerson, head of clinical quality management at EMD Serono, executive sponsor of TransCelerate's ICH E6(R3) Initiative & PhRMA topic lead on the ICH E6(R3) Expert Working Group; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, and ACRO member participating in the ICH E6(R3) Initiative with TransCelerate, discuss:

Industry collaboration through TransCelerate and ACRO's partnership 

Tools to help stakeholders better understand the latest GCP guidelines

Their own recommendations for best practices in risk management and data governance

Podcasts

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

Unifying Industry to Better Understand GCP Guidance

Strategies for sponsors in navigating the European Union's new health technology assessment regulation. 


Preparing to Achieve with Joint Clinical Assessments

As stakeholders debate fair market value in clinical trial budgeting, a new task force works to align sponsors, CROs, and sites on transparency, sustainability, and efficiency.

Exploring Perspectives of Fair Market Value in Clinical Trial Budgeting

Case study highlights how clinical operations teams can overcome complex regulatory and operational hurdles to finish a trial on time and on budget.

Overcoming Operational Challenges in Oncology Clinical Trials:  Lessons from a Multicentric Study in India

Despite positive results from a Phase I/II trial of its investigational pandemic influenza vaccine, mRNA-1018, Moderna’s award for almost $600 million to accelerate vaccine development will be terminated.

HHS Cancels Moderna Grant for Late-Stage Development of mRNA Vaccine Candidate

While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.

Clinical Trial Monitoring: Should Randomization Be Included?

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discusses how key stakeholders in clinical research are responding to uncertainty with budget cuts and administrative shifts.  

Redefining Collaboration in Clinical Trials: How Sponsors, CROs, and Sites Can Align

, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discussed the Trump Administration's ‘Most Favored Nation’ pricing policy for pharmaceuticals, which aims to match the lowest global prices to reduce costs in the US. Based on his past experience at Eli Lilly, Kremidas expressed concerns about the policy’s impact on pharma companies' clinical development and NIH funding, which could lead to reduced investment in new therapies. Kremidas also highlighted the potential of multisite clinical research corporations (MCRCs) and how they can streamline clinical operations by consolidating contracts and improving efficiency.

ACT: Looking forward in this landscape of uncertainty with budget cuts and administrative shifts, how can key stakeholders in clinical research better collaborate to support both innovation and affordability?

I think first and foremost, one of the most important things is communication and transparency. If you think about MCRCs or just sites in general, they're sort of at the end of the line, if you will, so you have the sponsor developing the protocol. In many, many cases, the CRO executing that protocol from a management perspective, and then, of course, the sites executing the protocol in terms of dealing with the patients and collecting the data. Often, again, in the past, what has happened is the protocol gets developed, it’s thrown over the fence to the CRO, the CRO then throws it over the fence to the sites, and there's not an ongoing communication during the development and execution of that protocol. That's not to say there aren't examples where it happens. I don't want to imply that, but I think there are plenty of opportunities to be more engaged from the beginning of the design of the protocol, both with the CRO and with the sites, as well as through the execution of how that then gets put into place from an operational perspective, so that's one area.

Along with that—still with transparency, communication—as things are ongoing, getting information back from sites about what are the experiences with collecting the data and engaging the patients, etc. The other thing I think that is important is the whole idea of training. If you look again at the traditional site training model, each site is trained differently, and it might be by different CRA, so you're going to get inconsistency. One of the things I learned when I was deeply involved with Six Sigma is the more variance you have, the higher the probability that you're going to have errors or inconsistencies, so the idea is, the more you can be consistent, and the fewer people involved in doing the training, and the more standardized the training is, the better quality you're going to get from an execution standpoint, so that's an area.

Finally, there's a whole idea of shared risk models. I think over time, we're going to see the MCRCs partnering with pharma companies and with CROs. In fact, with CROs, as you're probably aware, some CROs already own their own MCRCs, so they're seeing the vertical integration as an opportunity. We see it the same way. We think that the vertical integration of the sponsor, to the CRO, to the sites, or from the sponsor directly to the sites, is a huge opportunity. There may be ways to share the risk of the development of a particular product or the execution of a particular protocol.

Videos

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discusses how key stakeholders in clinical research are responding to uncertainty with budget cuts and administrative shifts.

Vendor Strategy & Collaboration

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discusses the administration’s policy and how it could force pharma companies to reduce funding for clinical R&D.

How Trump’s Most Favored Nation Policy Could Impact Funding for Clinical Development

ACT: Can you briefly explain what the Trump administration's 'Most Favored Nation' pricing policy is trying to achieve and how do you view the potential impact of the pricing reforms on pharmaceutical companies' clinical development strategies?

 The Most Favored Nations idea is, if you look around the world at the prices of various pharmaceutical products, you'll see there's quite a variance. The United States has always been one of the highest, most expensive places to purchase pharmaceuticals, and then there are other countries, both in the industrial nations as well as in developing nations, that have significantly lower prices. Now a quick bit of information, early in my career, when I was working for Eli Lilly, I actually worked in the pricing department for a while, and indeed, we did have different prices based on a number of factors. One, competitive pricing. Two, what the market would bear, as well as trying to understand the type of margins that we needed to make in order to continue to do our research and develop new therapies for patients in the in the future. I think what the Trump administration is trying to do—and by the way, the Biden administration actually got this started with, with the negotiations on Medicare and Medicaid pricing—is to reduce the costs to patients and to insurance companies in the United States, as well as to the government. I understand why people feel that way. The fact is that most of the US population feels like their products are too expensive, so the goal in the Most Favored Nation is to look at what is the lowest price around the world and match that price. Now, whether or not that makes sense is questionable, because some of the prices are so low in some countries that there's no way the pharma companies could actually market and sell their products that low in the United States.

If indeed these products were to be sold at a lower price, that would eat into the money that that the pharma companies and biotech companies have to invest in clinical development or research, so it could have a detrimental effect on future therapies, because there may be less money to invest in developing those therapies, so that's a concern. The other piece of that, which we didn't really touch on is a lot of the funding being cut on NIH studies, because that's where most of the early discovery takes place, and unfortunately, cutting those funds could eat into the development of new scientific concepts that would lead to new therapies, so we're kind of getting hit with a double whammy of this Most Favored Nations project or concept goes through.

In this video interview, Ron Lanton, partner, Lanton Law, highlights how tariffs on active pharmaceutical ingredients could affect resources for maintaining and accelerating R&D pipelines.  

Rising API Tariffs Are Forcing Pharma to Shift R&D Resources

, Ron Lanton, partner, Lanton Law, discussed the impact of drug cost increases on clinical research, predicting a reduction in government-sponsored trials due to higher R&D costs and potential funding cuts. Lanton also touched on FDA inspection cuts and how they are expected to slow down the clinical trial supply chain, leading to longer approval times and reduced site readiness.

ACT: How could the threat of tariffs impact the active pharmaceutical ingredients (APIs) market? Could this increase the cost of conducting clinical trials?

I think tariffs on APIs will definitely increase costs to everybody who has touch points in the supply chain. Pharma obtains a significant amount of APIs from the global market, and I think that's going to lead to increased expenses and a lot of difficulties in sourcing essential ingredients that we need for the APIs. I think the companies might respond to these challenges by reallocating resources meant to maintain or maybe accelerate their R&D pipelines in order to address the issues, but I definitely think it's going to result in an increase of cost.

In this video interview, Ron Lanton, partner, Lanton Law, highlights how tariffs on active pharmaceutical ingredients could affect resources for maintaining and accelerating R&D pipelines.

In this video interview, Ron Lanton, partner, Lanton Law, talks FDA layoffs and their impact on inspections and clinical trial timelines. 

How FDA Cuts Are Creating New Bottlenecks in Clinical Operations

ACT: How could cuts to spending devoted to FDA inspections impact the clinical trial space?

I think, despite assurances that inspectors would not be affected, the FDA layoffs that occurred last April eliminated a lot of support staff who handled a lot of visas and travel arrangements and other logistical operations of the inspections, and in doing so, that effectively made the availability of inspections go down, because inspectors are now responsible for an additional workload, so you can kind of see like a supply demand issue here. Fewer inspections will mean longer wait times for approvals, longer periods between clinical trial stages are going to happen. I think the longer the wait between that stuff, the bigger possibility that a site's private funding will also be cut or put on hold. I think that while demand for site partnerships from pharma sponsors that's at an all-time high of what we've been seeing, I think a reduction in site readiness will significantly slow down the entire clinical trial supply chain, which it's unfortunate.

In this video interview, Ron Lanton, partner, Lanton Law, discusses how a potential increase in drug costs could affect the clinical research industry.

The Hidden Impact of Drug Pricing on Government Clinical Trials

ACT: How would a potential increase in drug costs affect the clinical research industry?

 I think most likely it would reduce government sponsored clinical trials and not the industry sponsored clinical trials. You go back to the Sovaldi incident in 2013 where there was this huge drug price increase on that one drug, and everybody's like, “Oh my god.” And they were like, “Oh, well, the reason we did is because of better science,” and it's kind of the same reason here. Pharma has always said that increased drug prices are the result of higher R&D cost and better outcomes, so it's the same argument just presented here. I think if a drug increases for any other reason, the manufacturer would just simply pass that on and just add that cost into its market price, but I don't think this is the case for any government sponsored clinical trials. We've already seen cuts in research from the administration, and I think it's likely that HHS could use the issue of drug price increases as a way to further cut the funding for this. That's what I foresee.

In this video interview, Michael Liu, discusses the need for continued monitoring of these medical research cuts to gain a better understanding of exactly what trials they are impacting.

Monitoring NIH Funding Cuts

, Michael Liu, medical student and researcher at Harvard Medical School, discussed a recent 

 on National Institutes of Health (NIH) grant cuts. Among other notable findings, the study highlighted that 20% of terminated grants were early career training grants, which are crucial for maintaining biomedical research pipelines. Liu also highlighted how the cuts have disproportionately affected institutions nationwide and compromised ongoing clinical trials, particularly those involving marginalized populations.

ACT: What do you think the future holds for the clinical research industry amidst the funding cuts?

I think it remains to be seen. One essential thing is just continued data monitoring and transparency from the government. I think that's one of the biggest things that we hope that our study is a call to action for. It's a really great step that the administration has put out this database of terminator grants, but there's so much more, making it easily accessible to pick out which ones are clinical trials and what topic areas of these trials they are. I think that's critically important. As all of you know, the NIH is publicly funded, and as the public, we deserve to have the knowledge. I think beyond that, also understanding what are the reasons behind grand terminations. That is a huge limitation that we don't understand. It doesn't give researchers and trialists the opportunity to respond to be able to make adjustments to whatever their projects are. I think that's an important next step. I think we just need to continue to monitor what's going on and what the impact will be on the clinical research landscape.

In this video interview, Michael Liu, medical student and researcher at Harvard Medical School, highlights key findings from a recent breakdown of funding cuts and how they are impacting research institutions.

How NIH Funding Cuts are Affecting Academic Research

ACT: What stood out the most to you from the results and what are your greatest takeaways from them?

I think there are three big things, three biggest takeaways. The first one, the top line findings, that during our study period, we found that there were about 700 grants that were terminated by the NIH and it totaled to about $1.8 billion. This is a large number, but it is proportionally a relatively small amount of all NIH funding. It's about 3% of all NIH funding. However, these cuts weren't felt equally across all institutes, and what we saw was exactly that, that there were some institutes that were hit harder than others, and we found that, for example, the largest grant cuts in terms of absolute amounts was at the National Institute of Allergy and Infectious Diseases, about $500 million, and then when you look at the proportion of all funding that each institute administers, it's about a 30% cut at the National Institute of Minority Health and Health Disparities, and that was the institute that was affected the greatest, so that was probably my first takeaway.

The second one is that, anecdotally, a lot of people, I think at least myself and my team, came in thinking that these cuts would occur at some of the more private institutions, some of the more elite coastal institutions that we think about. We are part of those institutions here, so that was kind of our a priori assumption, but we actually found that institutions of all stripes were affected. These were the private institutions that you think about; Harvard, Dartmouth, Yale, and those also include flagship public universities as well such as the University of California, San Francisco. Really across the United States, we're seeing really, really drastic cuts, and no one is spared by it.

The third thing that I will say, and this is kind of deeply personal to both me and a lot of the other researchers on the team. We're all early career researchers, and we were struck by the fact that about one in five or 20% of grants that were terminated were classified as early career training grants. These are the F series grants, T grants, K grants, and these are really important grants for several reasons, which I'm happy to talk about, but they are essential for maintaining the pipeline of biomedical clinical research in the United States. The fact that they were being cut, perhaps disproportionately, was really, really striking to us.

In this video interview, Michael Liu, medical student and researcher at Harvard Medical School, discusses a recent study he conducted on the characterization of research funding cuts. 

A Closer Look at NIH Grant Terminations

ACT: Can you tell our audience a bit about the paper you recently authored on NIH grant cuts?

We and a team of really talented researchers—some at Harvard and some at Yale—did a recent analysis. First of all, what motivated this analysis, we were in late February, early March, we were following the news of NIH grant terminations, which I'm sure many listeners have been following very closely as well. We are all part of organizations and institutions that receive NIH funding, and I actually have colleagues and mentors who have received grant terminations themselves. This is something that's very near and dear to our hearts, and even though during this time frame, we were hearing more anecdotes, and there's, frankly, a lot of chaos and uncertainty about both the scope of terminations, what types of grants were being terminated, and who was being affected. As researchers, we're really interested in putting data to stories and subjective reports, so that's what we set out to do in this study.

This study was enabled by a new dataset that was released by the by HHS, the Department of Health and Human Services, and it's essentially using data from their TAGs (Tracking Accountability in Government Grants System) dataset, and this is a new set that was actually, ironically, in response to President Trump's radical transparency around wasteful spending memo, and that dataset has essentially all up to date information about grant terminations in real time. It's a dataset that's updated essentially weekly, if not even more regularly than that. We were able to extract information, detailed information about each grant using their unique identifying number, and then using that information, pulling information and linking that to other datasets to find what institute administered that grant, who that grant was for, what kind of grant it was. Then, I think the really novel part of our study is that we were able to then link that dataset to the NIH RePORTER repository, which is essentially a dataset of all active NIH grants, and that, for the first time, allowed us to provide a denominator, which I think, a lot of news organizations and very, very smart folks have tried to look into this, but, we wanted to get a sense of a top line number of “X” number of grants were cut, but it's much more important, I think, to get a sense of what is a relative impact of terminations when you look at the NIH as the largest funder of all biomedical research globally, what is the relative impact? That's what we ended up doing.

In this video interview, Krinx Kong, chief commercial officer, Cognivia, discusses how clinical operations professionals should be focusing on flexibility, behavioral visibility, and communication in the current landscape of managing vaccine trials.

Current Areas of Focus for Clinical Operations Professionals in Vaccine Trials

, Krinx Kong, chief commercial officer, Cognivia, discussed the potential impacts of policy shifts on vaccine trial design and patient perceptions. Stricter regulations could increase trial complexity, affecting recruitment and retention. Kong emphasized behavioral insights as crucial to understanding patient motivation and mitigating dropouts. Looking forward with the potential for policy changes in vaccine trials, clinical operations professionals must focus on flexibility, behavioral visibility, and effective communication to ensure success.

ACT: Looking forward with the potential for policy changes, what should clinical operations professionals involved in vaccine trials be keeping top of mind?

Clinical operations professionals are the backbone. They're the unsung heroes of successful trials, and they're also the first to feel the effects of regulatory change. If vaccine policy continues evolving, clinical ops leaders must focus on three key areas. First, flexibility. Build trial designs that can adapt to new data, new regs, or even public sentiment, that includes modular protocols and contingency plans for recruitment or site engagement. Second, behavioral visibility, it's not enough to track visits, check a box, or lab results. Ops teams must understand the psychological journey of participants, when they're likely to disengage, how they interpret study expectations, and what motivates them to stay. Third, communication. Clear, trust building messaging is essential, not just the participants, but also the site staff, to regulators, and the public. Clinical teams must be equipped with predictive tools to monitor adherence, risk, dropout likelihood, and placebo response all in real time. I know that's asking for a lot, but in summary, to my fellow ops family, be agile, be human centered, and be proactive. Vaccine trials are not just scientific, they're social, and the teams that understand both sides will be the ones who thrive in the next phase of clinical research.

In this video interview, Krinx Kong, chief commercial officer, Cognivia, highlights how patients’ perspectives on vaccine trials may shift if a policy change was to take place.

Public Perception of Clinical Research Amidst Policy Changes

ACT: There are already challenges with how patients perceive clinical research. From their point of view, how could a potential policy shift with vaccine trials further affect perception and trust?

Vaccine trials are already subject to intense public scrutiny and often misunderstanding. Therefore, when political or policy discussions suggest a new use of placebo controls, even though they've been long been the gold standard, it can create confusion. From the patient's perspective, this can sound like researchers are just now deciding to withhold treatment, which naturally triggers concern or mistrust. The truth is, placebo use is well governed and deeply rooted in evidence-based medicine. However, perception is everything nowadays. If patients or the public believe vaccine trials are less transparent or less ethical, that perception alone can damage trust, and we're seeing that today. That's why it's imperative to consider behavioral insights as a core aspect of trial success. Sponsors need to understand how participants interpret trial protocols, not just whether they follow them. This understanding helps trial teams communicate more clearly, empathetically, and persuasively, so patients feel safe, informed, and valued, even in a complex or high-profile trial in the era of misinformation, perception is no longer a side issue. It's central to both enrollment and impact.

Regulatory

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