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Dr. Hanne Bak, Senior Vice President of Preclinical Manufacturing and Process Development at Regeneron speaks about her role at the company as well as their work with monoclonal antibodies, the regulatory side of manufacturing, and more.

Podcasts

What Can ClinOps Learn from Pre-Clinical?

A new systems-based framework helps sponsors and CROs move beyond prediction to understand why site selection succeeds or fails, enabling targeted interventions that boost recruitment, data quality, and trial efficiency.

Beyond Prediction: An Evidence-Based Framework for Assessing Site Selection Decisions

An overview of how recent funding reductions are reshaping clinical trial operations, from site sustainability and patient recruitment to trial design and long-term strategy.

How In-Home and Community Strategies Boost Recruitment and Diversity

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

In this Q&A, Rohit Nambisan, CEO of Lokavant, and Jonathan Crowther, head of predictive analytics, Pfizer, explore how AI is transforming study feasibility, regulatory review, and trial execution.

Q&A: How AI Is Reshaping Clinical Operations and Study Feasibility

Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), and Kyle McAllister, co-founder, CEO, Trially, discuss how research sites are navigating political funding pressures, adapting to NIH budget constraints, and leveraging new cost-containment strategies to sustain clinical research.

How Research Sites Balance Funding Cuts and Efficiency Pressures

 Clearly, this is a very polarizing time politically for a lot of folks, but I think objectively, most would say that efficiencies are needed, and that would be a good thing. We want our public research dollars to make the greatest possible impact, but it does feel like many of the actions to date have been, the visual is more chainsaws than scalpels. We see things being targeted, like the role of overhead with NIH funding of academic research and that seems like an easy target just to go after, but it has tremendous consequences. Overhead in academic research supported by the NIH supports intramural research, those research initiatives that are being funded by the universities themselves, that often provide the seeding of what future research we want to go after, those are often the higher risk, smaller things to go after.

 Ultimately, they're doing more with less, like I said before, they're resource constrained, and they're doing more with less, which looks like a lot of things, but it's leveraging new technologies like telemedicine or other tools that could decrease the cost of the actual care being provided, so cost containment measures, using remote monitoring tools, using teams that didn't previously work together across multiple types of studies or departments. We've seen sites turning more towards industry sponsored trials to drive more revenue and ultimately cover some of the research they're doing that was NIH and other government funded research, essentially using pharma money to keep the lights on and keep things moving forward.

Videos

In this video interview, Caroline Potts, general manager of sites and patient services at Medical Research Network (MRN), highlights how listening to site insights and adopting flexible models such as temporary community-based clinics, can reduce patient travel burdens, improve enrollment efficiency, and stretch trial budgets further.

How Flexible Site Models Can Cut Recruitment Costs and Timelines

, general manager of sites and patient services, Medical Research Network (MRN), discussed operational flexibility in clinical trials, emphasizing the need to avoid staff burnout due to inflexible SOPs and budget constraints. She highlighted strategies such as in-home visits and community outreach as essential for reducing recruitment delays and improving trial diversity. Potts also touched on budgetary issues as a major barrier to patient-centric models, with a call for better dialogue and innovative solutions. She stressed the importance of community engagement, temporary clinic sites, and collaborative efforts among key stakeholders to better serve diverse populations in clinical trials.

ACT: Given that up to 30% of a trial’s 

 goes to recruitment, how can more flexible site models lead to greater cost-efficiency and faster timelines?

: I think there's a couple of things that I wanted to mention in relation to that. The first is, listen to what your site is telling you. Listen to the patient population that you're looking to reach out to. The site will know their patients better than anyone else. The sponsor and the CRO might know the condition more, they might know the science more, they will certainly know the study better, but the trial sites, you can't get away from the fact that the trial sites know their patients very, very well, and have probably had very lengthy relationships looking after the patients in their community. They will know what the bus schedule is. They will know that patients who live in one end of town, it's going to take perhaps two changes of bus and walking and leaving a really early or late part of the day in order to get to take part in a trial. All of those things matter, so allow the site an opportunity to voice what they think will work.

Then also, when is a site not a site? What about if we really did see patients in their community, what if we were to have a more temporary model of clinic sites in a community that is perhaps in the town hall, that is perhaps in the sports center? Actually, what it means is that everything that is familiar to that community remains in the community. There is still a link with the site and the site team that the patient has always had contact with, but actually it means that they don't have to make that long bus journey, that they don't have to think about carers or having childcare provision or taking time out of work. What about if we really took the trial to the community and were able to set up in that environment? It certainly helps the study budget to go further, and actually, what you find is that patients do like the idea of just being seen in their locality. We live in an age where you can press a button and coffee is delivered, or food is delivered, or whatever your heart desires can be delivered the next day. It's asking a lot now for patients to sign up to something that potentially is two or three years in length and means that they have long distances to travel and long days away from home when that not might not be the easiest thing for them to do.

In this video interview, Caroline Potts, general manager of sites and patient services at Medical Research Network (MRN), outlines how rigid budgeting and limited sponsor-site dialog often block innovative patient-centric solutions, stressing the need for more collaborative approaches to enable community engagement and flexible trial delivery.

Overcoming Budget Barriers to Patient-Centric Trial Models

ACT: What are the biggest operational barriers preventing sites from adopting more patient-centric trial delivery models?

Truthfully, I think it's the way that the budgets are put together. I'm not trying to say that sites and site staff are all good, and trial sponsors and trial CROs are all bad. It's not as easy as that. That's not what I'm saying here, but I think there is more dialog that could certainly help a site to feel that they can put forward a slightly more unusual solution, like community engagement. That tends to be one of the things that we hear gets knocked out of a budget suggestion and a first iteration of a budget, which is a real shame for the reasons that we've just been talking about. I think that trials are expensive. Trial sponsors, trial CROs, are still on the receiving end of opening sites where there is no recruitment despite best intentions, so we have a bit of an impasse with everyone making really good arguments as to why they can't think outside of the box, but it's that old adage, if you always do what you've always done, you'll always get what you've always got, so we do have to think more laterally and maybe just give it a try. I'm not suggesting throw millions at it when we don't know if something has been tested and has been successful, but the dialog needs to be had, and the discussion should always remain on the table.

In this video interview, Caroline Potts, general manager of sites and patient services at Medical Research Network (MRN), discusses the challenges of achieving true operational flexibility in clinical trials—highlighting how SOPs, staffing, and budget constraints often limit site adaptability and contribute to staff burnout.

The Reality of Operational Flexibility for Trial Sites

ACT: What does operational flexibility really look like for sites today? How can it be implemented without adding to staff burnout?

I think the key point there is the staff burnout. I think everyone likes to genuinely believe that operational flexibility exists, and I'm just not sure that that is the true lived experience of site staff. I think that everyone wants to do a good job, everyone wants to be able to offer solutions that perhaps are nonstandard, or seen as nonstandard, but SOPs, budgetary constraints, time constraints, availability of staff, availability of patients, all of those things can—more often than not—count against this idea of having the flexibility. I think that it does run the risk of leading to staff burnout as a result of that, unfortunately. It's a great concept, and I think everyone should still continue to try to strive for it, but I think the reality is a little bit different to that.

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.

The Critical Role of Clinical Ops Teams in Maintaining Clinical Trial Integrity

, Ron Lanton, partner at Lanton Law, discussed the pivotal role clinical operations professionals play in maintaining the integrity of clinical research and ensuring regulatory decisions are firmly grounded in robust data. He emphasized that as federal guidance evolves and new technologies like AI tools are increasingly integrated into trial processes, the responsibility of clinical operations teams to oversee quality control, protocol adherence, and data auditing has never been more critical. Lanton also highlighted how shifts in policy—particularly those affecting vaccine access—can ripple through clinical trial design, participant recruitment, and public trust, with implications for both minority populations and broader investment in vaccine research.

ACT: What role should clinical operations professionals play in ensuring that regulatory decisions remain grounded in robust clinical trial data and scientific consensus?

Clinical operations professionals play a key role in maintaining the integrity and reliability of clinical studies by focusing on quality control and strict adherence to protocols. With recent changes in federal guidance, it’s increasingly important for these professionals to prioritize this aspect of their work and consistently audit the data they oversee. Federal guidance can also influence how technology tools, such as AI processes, interpret information, making careful oversight even more critical. Ensuring that audits and data management are conducted with these considerations in mind helps safeguard the quality and credibility of clinical trial outcomes.

Clinical operations professionals play a critical role in ensuring that regulatory decisions are grounded in reliable clinical trial data and scientific consensus. A key responsibility is maintaining rigorous quality control and strict adherence to study protocols. This helps ensure the integrity and reliability of collected data, which is essential as federal guidance evolves. With ongoing changes in regulatory expectations, clinical operations teams must reprioritize auditing and management of trial data, particularly as new technologies, including AI-driven tools, are increasingly used to analyze information. Consistent oversight ensures that these tools interpret data appropriately and that regulatory decisions remain evidence-based.

Policy shifts affecting vaccine access can have wide-reaching consequences for clinical trial design, recruitment, and public participation. Reduced access and changing guidance could decrease public engagement in future vaccine studies, potentially returning participation levels to pre-pandemic lows. Federal guidance significantly influences public trust, and ongoing challenges in trust—especially among minority groups historically overlooked or negatively impacted in clinical trials—could further complicate recruitment efforts. Lower trust may also discourage broader institutional and industry investment in vaccine research if government backing is limited or inconsistent.

These dynamics suggest that clinical trials could face more complex design and recruitment challenges, requiring careful consideration of public perception, engagement strategies, and equitable inclusion of diverse populations. Maintaining robust scientific standards, transparent communication, and adherence to regulatory guidance will be crucial to mitigating these risks. Without proactive measures, both the integrity of clinical trials and the public’s confidence in vaccines and other interventions could be undermined, with lasting effects on public health initiatives and future research investment.

Ron Lanton, partner, Lanton Law, explains why evolving federal guidance and new technologies are pushing clinical operations teams to strengthen oversight and safeguard the credibility of clinical research.

Video Series

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.

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, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, shares key strategies for maintaining operational alignment and compliance in decentralized trials including unified data platforms, aligned SOPs, and clear governance and escalation pathways between sponsors and supply chain partners.

Best Practices for Operational Alignment in Decentralized Trials

, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed the role of data visibility in clinical trials, emphasizing the need for actionable data to meet aggressive timelines and budgets. Remote monitoring is crucial for quick decision-making and patient safety, reducing site burdens and leveraging advanced technology. Integrated systems help study sponsors meet evolving regulatory expectations by removing data silos and streamlining inspection processes. Barriers to real-time trial oversight include data silos and the need for integrated systems. Best practices for decentralized trials include unified data management, clear SOPs, and governance pathways to ensure operational alignment and regulatory compliance.

ACT: As trials become more decentralized and data sources multiply, what best practices can ensure operational alignment and regulatory compliance throughout the trial lifecycle?

Yeah, so I think again, unified data management platforms, that's probably number one, establishing clear SOPs and training, again, between sponsor and supply chain companies, making sure that the teams are highly aligned. Another thing that may seem tactical, but it's super important, is creating clear governance and escalation pathways. I think, again, this is something that I really want to double click on, that as an important component of a collaboration between again, sponsor and supply chain partner.

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