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Liz Beatty, co-founder and chief strategy officer, Inato, discusses:

The role of technology in improving site/sponsor relationships

How increased operational costs are impacting the industry

Podcasts

In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more. 

Improving Relationships and Diversifying the Site Selection Process

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

A pragmatic approach to streamlining technology and innovating processes will help advance clinical data management.

Less is More in Clinical Data: The Road to Simpler and Better Trials

Improving access while maintaining a high level of research.

Advancing Patient Engagement in Community-Based Oncology Research

How today’s SSO reduces site burden and spearheads clinical system interoperability.

The Latest Advancements in Single Sign-On Technology

Survey from the Site Council gathered insights from its members on the quality of site coordinator work.

Understanding Study Coordinator Work Quality

In this video interview, Kyle McAllister, co-founder, CEO, Trially, shares real-world examples of AI transforming clinical trial recruitment.

AI Levels the Playing Field in Trial Recruitment

, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts on underrepresented populations in medical research, emphasizing the importance of diversity-focused research. He highlighted the challenges created by budget cuts, particularly in patient recruitment and retention, due to reduced support staff. McAllister noted that artificial intelligence (AI) and new technologies like telemedicine are crucial for addressing these challenges by automating tasks and improving efficiency. He provided examples of AI's success in reducing chart review time and increasing patient enrollment in studies.

ACT: Are there examples you've seen where AI or digital tools have already made an impact on trial recruitment efficiency or targeting?

Absolutely, we're watching it every day. Like I said, the patient screening capability that we're rolling out to sites, we've seen sites decrease their chart review time by 90%. We also stack rank patients, so we can say, “Hey, these are the patients that fit,” and stack rank them based on their fit. That alone cuts 60-70% of the screen fail rate, because we're not spending time talking to patients that won't be a good fit for the study. Those are two really quick hit outcomes we've seen.

One really interesting, specific example that I love talking about, because I think it's just such a perfect example of how AI can be helpful in this space, is we have a, I would say, mid-size cardiology clinic that we work with. They have this really complex heart failure study that they've been recruiting for years. They've been on the study for—before we got connected—a year and a half, they had one patient recruited. The study was really struggling. The sponsor is breathing down their necks trying to get more patients into the study. After we got connected, it's been four months, they've now got seven enrollees in the trial, and now the sponsor is coming back like, “How did you do this? How could you possibly make this happen?” The really cool part, the part that gets me really excited, having spent time in the site world myself, is that was one research coordinator at one mid-sized site, and the second-best recruiting site on the study after her, is a giant academic institution with 20 CRCs coming through a huge database of people. It just really shows the power of really leveraging these tools can up-level a single individual to cover a lot of ground. Back to all the talk we've had about resourcing, it does take some lift off and make it so one person can achieve more. That’s just a handful of examples we've seen on the ground.

Videos

In this video interview, Kyle McAllister, co-founder, CEO, Trially, explains how AI is stepping in to fill staffing gaps in clinical research—streamlining patient identification, real-time feasibility assessments, and automated prescreening to help sites stay operational and efficient despite budget cuts.

How AI Can Ease Recruitment Burdens in Resource-Strained Trials

ACT: How can AI help address some of the recruitment challenges caused by reduced funding?

It's a difficult time in the industry for a lot of folks, but in a lot of ways, it's kind of AI's time to shine. We're seeing decreased human resources, but that's where AI is really supposed to pick up the lift, so I think AI can really augment a lot of basic tasks. It can leave, and ultimately, hopefully leave research teams to practice more at the top of their license. “Let's take the let's take the dirty work off your plate and let you focus on the things you came here to do, which is see patients and care for patients.” This is going to be very slanted based on a lot of the things we work on at Trially, but some of the big, big, exciting things that I see folks getting excited about for AI are, one, AI-powered patient identification. AI can sift through large amounts of data from EHRs, from CTMS systems, even from PDF documents, taking what is, 30 plus minutes, hours of time, reading through patients’ charts down to moments. That’s huge. We've had sites where we have teams that do 90% less chart review than they did before the system gets implemented. Quick example, I spent my entire career before this, before basically OpenAI and Sam Altman happened, telling physicians that if you write it in a note, it's gone forever. In the time I spent at Epic and Cerner, that was the message, it's got to be documented discretely. That's just not true anymore. We can sift through a lot of that information and do it really quickly, which is powerful, that's industry shifting capability, so that's one.

The other would be, if we're already in there sifting through all that data, you are resource constrained as a site. Picking the right study, picking the studies that you're going to crush it on, is really important, so the ability to actually do real-time feasibility on that data set, and understand, do I have a population that supports our research? Us taking on this study is really big, so real-time feasibility, real-time business development and site select, or trial selection without guesswork, are really big things.

Then the last I'd call out is, you hear a lot about automated prescreening and engagement of patients with AI voice in call screen, and actually engage these patients directly with very human like capability, and that's a huge lift for sites. In my time actually working at a site network, it was a massive pain for all of our research coordinators to have to call, say we're doing a vaccine study and we have 10,000 potential candidates. How do you call 10,000 of those people to try to screen them into a trial. AI can really take the front-end lift of that, take the initial outreach, and then hand it off to a human to really close the deal and bring them in for the study. There's probably a thousand more use cases that I didn't hit, but those are some of those that are closest to our hearts.

In this video interview, Daniel McAllister, Kyle McAllister, co-founder, CEO, Trially, discusses how clinical trial sites and sponsors are responding to funding constraints by turning to telemedicine, cost-containment strategies, and increased reliance on industry-sponsored research.

How Sites and Sponsors Are Adapting to Clinical Trial Budget Cuts

ACT: How are clinical trial sites and sponsors adapting to these constraints?

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. Not all that's terrible, like the idea of moving towards more efficiency and finding ways to drive more revenue to keep things more sustainable, there's some positive things in that, but I think the one of the big potential conflicts is it creates is a lot of the shift towards more industry sponsored research means the institutional priorities being shifted away from public interest focused research. Like I said, there's some pro in that, but there's also some real conflict and concern.

I think the brutal reality for a lot of sites is they're being forced to adapt in ways that aren't great, like they're having to cut staff, they're having to close departments, they're having to close research programs. I think there is a lot of, I'll say, research capacity that disappears with that, that it's going to take time to grow back. There's just research capacity that can't be covered, and we're in an age where it's easier and easier to find new molecules, find new things to do research on, and this infrastructure that was there to actually run that research is being whittled back. Sites are doing heroic work out there, but I worry that heroism isn't a sustainable staffing model.

In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how clinical trial sites and sponsors are responding to funding constraints by turning to telemedicine, cost-containment strategies, and increased reliance on industry-sponsored research.

In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), highlights the importance of equipping site staff and caregivers with tools and best practices to effectively communicate clinical trial opportunities to patients and improve enrollment rates.

Empowering Clinicians to Communicate Clinical Trial Opportunities Effectively

, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), discussed the current state and challenges of cancer patient participation in clinical trials. Barriers to participation can include lack of understanding, economic burdens, and implicit biases. Robinson highlighted solutions such as increased education, legislation like the Clinical Trials Modernization Act, and engaging patients early in trial design. He also touched on the use of technology, such as biomarker testing and wearable devices, which can also enhance recruitment and reduce burdens.

ACT: Can you discuss the importance of training and supporting site staff to effectively communicate trial opportunities to patients?

Absolutely, I think there's lots of opportunities to educate both caregivers and patients. I think the data would support the idea that about 50%, maybe even three quarters of patients would participate if asked, but only 20% of them are being asked. So, how do we bring that number up and get more people involved? One way is certainly to develop best practices procedures, to better equip or educate our caregivers, is one way. An example of how that how the NCCN is working to do that is through the Health Equity Report Card. It's a tool designed to provide best practices for those caregivers, and one of the outcome measures is a tool that includes or encourages providers to have clinical trial conversations with their patients. At the most recent annual conference held by NCCN last March, they had a best practices session where clinicians, advanced practitioners, etc. could go and learn about how to engage patients, understanding that important details need to be delivered by knowledgeable staff, how to do it in a comfortable environment, using patients native languages, etc., providing take home materials that are in plain language so that a patient can actually go and digest it after having gone home from the hospital. Also, videos from other patients who have participated in clinical trials, to get that patient perspective is also an important way that you can educate.

Patients should also be able to understand the purpose and the risks of the studies. I work in the Oncology Research Program at NCCN, and one of one of my jobs is to oversee the IRB director's form there, and the IRB is a governing body at institutions that makes sure that clinical trials are held to the most rigorous ethical standards, and that group has put together a plain language database that can be used by clinicians and others to develop the informed consent documents, those documents that help explain to patients what's going to happen, what their data are going to be used for, etc., so plain language is a key point, and similarly, the NCCN Foundation has developed patient oriented guidelines that explain disease and treatment approaches, again, in plain language for those patients. Lots of opportunities.

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.

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 need for more data and education on multisite clinical research corporations before adoption can become more widespread. 

Educating the Industry: Unlocking the Full Potential of MCRCs in Clinical Development

ACT: How are sponsors and CROs responding to this shifting landscape? Are they actively seeking out MCRCs, or is more education still needed?

In general, there's more education needed on the concept. There are a handful of sponsors and CROs that indeed, yes, they're going to the MCRCs, but generally speaking, this is a slow to change industry that we are in here. What I described earlier about going to the MCRCs first is not the standard approach, so therefore we definitely need more education and more data showing the value that MCRCs can bring to the industry and to bringing products to market faster.

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), talks multisite clinical research corporations and how they can streamline clinical operations.

Accelerating Site Activation and Recruitment with MCRC Partnerships

ACT: In your view, what are the biggest inefficiencies in traditional clinical trial operations today that MCRCs are well-positioned to solve?

If you look at the way that we go about working with investigator sites in today's environment, from a historical perspective, the approach has always been, you write a protocol, you take that protocol, and you begin to go out and talk to different investigator sites. “Hey, can you do this that you know your feasibility assessment? Do you have the capabilities? Do you have the right skill sets? Do you have the patient populations, etc.?” Now that approach is quite slow and tedious, if you will. Sometimes the sites are overwhelmed. They don't really want the study. Other times they would like to study, but maybe they're not the best site to actually conduct that study, so one of the things that we're excited about with the MCRCs, and that AMRC is trying to help people understand is that you can contract with an MCRC and get a number of sites all at once. Let me give you an example. Let's assume you have a study and you figure you need 40 sites. Now, we're not saying go to one MCRC and get 40 sites from that organization, but we are suggesting, instead of going one site at a time, why not go to two or three MCRCs, maybe you sign up 10 sites from one, 10 sites from another, and maybe 10 sites from a third, or maybe you get 15 from two of the MCRCs. You now sign two contracts, instead of 30 contracts. You now train twice instead of 30 times for the staff. You get consistent contracting, you get consistent feasibility assessments, you get consistent specialized support as it relates to technology, data management, queries, whatever it happens to be. Now you've got 30 sites out of 40. Fill in the other 10 with whatever else you need. If there's a location where you feel like there's a patient population you really would like to engage in the study, or if you want academic sites engaged in the study, then you can fill in the blanks. Historically, though, we go one at a time, which takes much longer than if you were to sign, in this case, you would be signing 12 contracts instead of 40 contracts. You see my point? That's one area. Just the startup timelines would be significantly faster, and indeed, there was a 

 in February that looked at the startup timelines for dedicated sites compared to the traditional sites, and indeed, it was much quicker. By the way, there's other data that was published in DIA last year that shows that the enrollment rates are about twice as fast with MCRCs as with traditional sites, so there's another area. Patient recruitment tends to go much more rapidly when you're using MCRC. There you have two elements that drive a much faster turnaround time for your study.

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), highlights opportunities to improve upon inefficiencies that currently exist in clinical workflows. 

Rethinking Clinical Trial Efficiency Amidst Cost Pressures on Pharma

ACT: We’re seeing increased financial pressure on pharmaceutical sponsors. Where do you think they'll look first to find cost efficiencies, and how do clinical trials fit into that equation?

There's two major areas, if you will, that a pharma company can look at. One would be in their sales and marketing or the commercialization of the products that they currently have available. I'm sure there are ways to cut costs there. I'm not going to go into that, because I think this audience is really more interested on the research and development side of the equation. As I mentioned earlier, it's going to have an impact in terms of the approach that pharma companies take to developing new drugs. Again, the area of the research side, so pre-clinical there's probably opportunities there to cut costs. I don't know if that's good or bad, probably bad, but on the clinical development side, we think that there are opportunities to reduce the costs of development. Now, a lot of effort these days is going into using new technologies in order to do that, for example, artificial intelligence and some of these other tools. One of the things that that we feel is important is to understand that the development of these of products, as you get through Phase I, II, and III for submission, technology helps, but at the end of the day, it's people who administer these studies. There are people that manage the studies, the site staff, the pharma company staff, the CRO staff, so there's going to be an awful lot—we believe—of opportunity to improve on the inefficiencies that currently exist from the way things are currently structured, in the way that we develop drugs, Phase I-III at this point in time.

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

, 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 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, 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.

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