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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

Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses:

Industry’s greatest challenges in reaching diverse patient populations

Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more. 

Reaching Diverse Patient Populations With Personalized Treatment Methods

As wearable ECG technology advances, cardiac safety studies in clinical trials are evolving to capture richer, continuous heart data while reducing patient burden.

The Future of Cardiac Safety: How Wearable ECGs Enhance Patient Monitoring in Drug Trials

In this Q&A, Megan Bailey, EVP and president of central laboratories and international, Labcorp, discusses how central labs are evolving beyond testing to become strategic partners in clinical trial success.

How Central Labs Are Powering Decentralized and Hybrid Clinical Trials

Clinical trials face a critical challenge: bridging the gap between patient curiosity and motivation to participate, impacting recruitment success.

The Curious vs. the Motivated: Rethinking Feasibility in the Attention Economy

How digital intake solutions driven by technological advancements can help overcome the challenges of operating across different regulatory markets.

Harnessing Technology and Adopting Unified Approaches to Optimize Pharmacovigilance Activities

In this video interview, Michel van Harten, MD, CEO, myTomorrows, discusses where the clinical research industry currently stands with AI adoption. 

Bridging Innovation and Trust with Artificial Intelligence

In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), shares his perspective on how clinical operations teams can evolve through patient-centered trial design, multi-disciplinary support, and enhanced education to address persistent barriers in cancer trial enrollment over the next five years.

How Clinical Operations Teams Are Adapting to Oncology Trial Challenges

, 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: How do you envision the role of clinical operations evolving to meet the challenges of cancer trial enrollment in the next five years?

I think we've discussed a number of different areas in which clinical operations can work or evolve to meet these challenges. I think recognition or incorporation of the patient voice is going to be important. As I said, companies are already starting to do that, ensuring measurements are meaningful to patients, getting patients perspectives on what they're willing to put up with. I think increased participation by navigators and multi-disciplinary teams is going to be important. As I've said, trials are complex, even having clinicians and scientists keep up with the changing landscape is difficult. Expecting patients to be able to do that, I don't think is fair. Having teams that are able to help them navigate that complex system is going to be really important, and then continued education through plain language resources is also a way that I think we're going to evolve.

Videos

In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), explores how emerging technologies such as wearable devices, real-world data analysis, and decentralized trial designs can improve the identification and engagement of potential cancer clinical trial participants.

Leveraging Technology to Enhance Cancer Clinical Trial Recruitment

ACT: In what ways can technology be utilized to identify and engage potential cancer trial participants more effectively?

This is actually a really exciting topic to me, because I think we are in an era where we can truly engage technology to help answer these kinds of questions. As I mentioned earlier, trials are becoming more and more complex because of the targeted therapies that we're testing in them, so using the kinds of modalities and technology that is available now for biomarker testing, real-world evidence, so large dataset analysis to really understand what patients have an opportunity to respond to these targeted therapies, etc. and you can sort of hone in on them, on those patients for trying to recruit them, is important. I think technology can also be used to address these economic and time burdens as well. When you think about smart watches, cell phone apps, wearable devices, a lot of the time and economic burden comes from patients having to travel back for extra scans, extra lab tests, those sorts of things. You can envision ways in which that technology can be used to supplement or take the place of those tests. Similarly, you can use in home testing to reduce travel time, to decentralize the trial designs. I think you could even take advantage of technology for developing better educational materials as well, so lots of opportunity, and I think it's an area of active 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

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, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), shares insights on the complex barriers limiting cancer patient participation in clinical trials and explores potential strategies for improving access and diversity.

Understanding the Challenges Preventing Cancer Patients from Joining Trials

ACT: What are the primary barriers that prevent cancer patients from enrolling in clinical trials, and how can stakeholders address these challenges?

I think, like any complex problem, it's multifactorial. There are patient associated factors, through a lack of understanding of what clinical trials are, what it means to participate in clinical trials, can certainly decrease participation. It can even result in lack of trust in the medical system itself. Also, inability to find trials. Trials, by their nature, are complex, and as we've developed more advanced types of therapies, ones targeting specific mechanisms or pathways that drive cancer, we're looking to enroll subsets of subsets of patients, not an all-comers sort of scenario. So, understanding what trials I would be eligible for if I were a patient is more difficult.

There's also provider associated barriers. Data supports the fact that African Americans are underrepresented in our clinical trials, and there can be multiple reasons for that as well, but those can be exacerbated by the preconceived notions. Clinicians say, well, African Americans don't participate in trial, so we even see that they aren't even offered the option of, so there's a sort of an implicit bias going in that can limit participation.

Then finally, there's economic issues. There's an undue economic burden that can be placed on patients, and that can be both time as well as monetary. When you think about the way trials are run today, they're often centralized, require patients to come back multiple times for visits or lab works, imaging, etc. That can take a toll on what patients have to do, days off of work, childcare, just the cost of lodging at the sites, and the hours it might take them to drive to where the trial is being held.

Just like there's a multifactorial reason for the for the barriers, I think there's multiple ways that you can address it—education. The NCCN, as an example, provides webinars and informational materials designed specifically for patients, to educate them, not only on their disease, but also on understanding the purposes of trials. There's legislation that is currently looking to be enacted, an example of which is the Clinical Trials Modernization Act, which the NCCN, as well as a number of many other patient advocacy groups support. It's designed to reduce economic burdens for those patients that we just discussed.

Then finally, the pharmaceutical industry recognizes, I think, is beginning to put an even bigger emphasis on the importance of the patient voice in trial design, so engaging those patients earlier, the patient advocacy groups, early in the trial design to really understand, what are they going to be willing to put up with in a trial? What are the important outcome measures for them as compared to something else? Lots of ways to address the question or the problems.

In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), discusses the persistent challenges of low cancer patient enrollment in clinical trials and why broader participation is critical for advancing oncology research.

The Urgent Need to Boost Cancer Patient Enrollment in Clinical Trials

ACT: Could you elaborate on the current state of cancer patient participation in clinical trials and why it's a pressing issue for the clinical research industry?

I just want to also start by saying thank you for the opportunity to discuss this really important topic. When you think about the current state of clinical trials, historically, if you go into the literature, it's been thought that participation has been very low, less than 5% of the patients actually participate in clinical trials, but a recent 

, where they looked at data from a five year period spanning 2013 through 2017, suggests slightly higher, albeit not that much higher levels. For therapeutic trials, about 7% of patients overall participated, but it depends on the setting that you're in, so patients in an NCI-Designated Comprehensive Cancer Center, slightly over 20% of those patients participated, but when you're in the community, only 4% of patients participate, and that's for therapeutic trials. There's also different types of trials that maybe you don't necessarily think of initially. For those things like diagnostic trials or quality of life studies, 2.5-3% of patients participate, and where we're seeing reasonable participation, in my mind, are for biosample repository studies, where patients are willing to donate their tissues for future research, and there almost a third of the patients will actually donate their tissues. I think there's room for improvement, particularly when you realize that the types of advances that we have seen in cancer care over the last decade or so, they stem from data that were generated in clinical trials, so having as many patients participate with as diverse patient population as possible is really important. As a side note, NCCN, the organization that I belong to, supports that idea. All the guidelines that they develop have a box on the front, stressing the importance of clinical trials where appropriate and applicable for an individual patient.

In this video interview, Michel van Harten, MD, CEO, myTomorrows, highlights the potential of artificial intelligence in digital twin technology. 

The Future of Drug Discovery: AI-Powered Predictions and Virtual Patient Models

, Michel van Harten, MD, CEO, myTomorrows, discussed the integration of artificial intelligence (AI) in clinical trials, highlighting its potential to reduce costs, accelerate timelines, and improve inclusion. Looking forward, advancements with AI are expected to speed up drug discovery, predict drug efficacy, and develop digital twins for personalized treatment simulations, potentially reducing trial risks and costs.

ACT: Looking forward, what are some other ways that you see AI having an impact on drug discovery?

In general, it will speed up drug discovery, which is usually a process that lasts for four years and costs billions of dollars. AI is helping, I think, scientists to go through huge datasets to identify promising drug compounds faster than ever before, and it will probably also predict which ones are likely to work, and also in which patient populations they will work, also with the level of precision we've never had before.

I think another thing that is very interesting is that we're also seeing major progress in something called digital twin technology, so that's a virtual replica of a real patient, and these models can simulate how a specific person might respond to a drug or treatment before they even ever tried it, so in the future, this could mean fewer risks and also fewer people needed for early trials.

In this video interview, Michel van Harten, MD, CEO, myTomorrows, discusses how patient education and remote monitoring can help with reducing the burden of trial participation. 

How AI Lowers the Real-World Barriers to Trial Participation

ACT: While there is potential for AI in operational aspects of trials, how can it benefit the patients participating in them?

I think it's important to lowering the barrier to actually identify and access options, and by educating them in a patient-friendly way, in their own language, and educate them. I think it's also important to support more remote monitoring to lower logistical barriers and reduce overall impact so that patients don't have to travel that much, etc. and lower the impact of participating into a trial.

In this video interview, Michel van Harten, MD, CEO, myTomorrows, highlights how artificial intelligence can be used to address logistical barriers such as access and treatment cost.

The Role of AI in Solving Clinical Trial Diversity and Access Challenges

ACT: How can AI be used to address underrepresentation in trials?

I think in general, access to clinical trials is a big deal, especially for people from underrepresented communities, and we believe that artificial intelligence plays a big role in changing that. Right now, the way to clinical trials and the way clinical trials are set up, often creates barriers that are very tough to overcome. Many trial sites are concentrated in big cities or academic medical centers, so if you live in a rural or underserved area, just getting to a trial might be out of reach, and for some people, there are also a lot of financial challenges like treatment costs or logistical challenges like transportation, and these burdens hit underrepresented populations especially hard, as well as people with lower incomes. Also, these people in those areas are not always made aware of the opportunities, not educated on the concept of clinical trials, and physicians are also not equipped to look for trials for their patients, so this leads to a situation, for example, in the US, where I think racial and ethnic minorities represent only 2% of participants in clinical trials, and that's of course a problem, because when certain groups are left out, we also miss out on crucial data, including how different people from different backgrounds respond to medications, so how can AI help? At myTomorrows, we lower the barriers for physicians and patients to identify and access trials. At the moment, we have two examples built into our product, where AI is used for treatment matching, where we save about 90% of the time that a physician is spending on matching a patient's profile to all those eligibility criteria. Second is education. As you know, the healthcare space is full of terminology which is very difficult to understand for patients and when it comes to clinical trials, it's even more complex, so AI can really help to translate consent forms, educational materials, etc. into multiple languages and use simpler terms, make it more accessible to non-English speakers and those also with low health literacy.

In this video interview, Michael Liu, medical student and researcher at Harvard Medical School, discusses how these cuts are impacting critical areas of clinical research such as staffing and patient access.

Medical Research Funding Cuts: A Disruption in the Clinical Research Enterprise

, 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: How have the NIH funding cuts affected the clinical research industry specifically?

Unfortunately, we didn't do an analysis of clinical research specifically, but it's not unreasonable to think that these cuts will have really impacted people in the clinical research industry, especially those who conduct trials. We know that trials are very expensive, and a loss of funding really compromises the ability to sustain and continue trials. I think what one thing that's really striking to us, I think I should’ve mentioned, was that a lot of grants that we saw were being cut were kind of cut halfway. There weren't grants that were just at the beginning or middle or the end. These could be trials that are in the middle of recruitment or in the data analytic period, and that's, I think, really deeply influential. They compromise our ability, whether you're delivering a drug or intervention, and not being able to afford continuing that or providing that to participants, if you're not able to employ staffs, research coordinators, research assistants, and to be able to keep the lights on in the building or lab, it's deeply disruptive.

I think the other thing that I would emphasize is that most times, clinical research, probably all the time, is that you're working with patients and patients place a lot of trust in us to be able to participate in trials and receive interventions. Particularly, we know that the NIMHD (National Institute on Minority Health and Health Disparities) was disproportionately affected, and these are interventions that tend to affect more marginalized disadvantaged populations and who already have rightfully so, distrust of healthcare systems and a lot of the research that we do. I think these cuts further potentially compromise the relationships and trust that we have with patients to continue to sustain the clinical trial enterprise.

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

, 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: 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.

Patient Participation

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