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1rem

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

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

Engaging with ineligible participants can transform a potentially negative experience into a positive one.

The Art of Saying No: Navigating Ineligibility Conversations with Clinical Trial Patients

Investigators find that most exclusion criteria in critical care randomized clinical trials are justifiable, but 60% include at least one poorly justified exclusion, most commonly affecting pregnant or lactating individuals.

Study Finds Many Randomized Clinical Trials Have Poorly Justified Exclusion Criteria

Study finds that addressing racial disparities in lupus clinical trials requires targeted education, increased diversity among trial staff, culturally sensitive recruitment strategies, and addressing social determinants of health to improve Black patient participation.

Addressing Racial Disparities in Lupus Clinical Trials

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

, 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: 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.

Videos

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

, 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: 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, Krinx Kong, chief commercial officer, Cognivia, talks patient recruitment and retention in vaccine studies as well as how behavioral, analytical tools can help patient support. 

The Potential for Stricter Regulations 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: How could stricter regulations around vaccine trials affect patient recruitment and retention?

Stricter regulations tend to increase trial complexity, more eligibility checks, longer consent forms, tighter protocols, and that absolutely impacts both recruitment and retention. The stakes are especially high in vaccine trials. Participants are often healthy volunteers, sometimes children, and they tend to be more cautious. If new regulations make trials feel riskier or more burdensome, we could see significant drop in recruitment. Retention is another concern. Stricter monitoring or rigid visit schedules may feel intrusive or exhausting for participants. That serves as a recipe for mid study dropout, which threatens both trial power and budget, and no one wants that. What's needed is a shift from focusing solely on protocol compliance to truly understanding the human aspect of participation. Why are patients enrolling in the first place? What worries them during the study and when are they most likely to drop out? Behavioral analytical tools can help identify and support at risk participants before they disengage. This kind of foresight is essential if regulations become more demanding and patients more hesitant.

In this video interview, Krinx Kong, chief commercial officer, Cognivia, discusses how trial design and timelines could be impacted by a potential mandate for placebo use across all vaccine trials.

How Vaccine Trials Could be Affected by Potential Policy Changes

ACT: US Health and Human Services Secretary Robert F. Kennedy Jr. recently 

 on supporting placebo-controlled trials for all new vaccines. How could a potential policy shift in this area affect trial design and timelines?

First, it's important to clarify that placebo-controlled trials are already the gold standard in vaccine development, and are required by both the FDA and EMA when no approved alternatives exist. Therefore, the notion that these aren't already in use is misleading, or at least lacks context. Now, if a policy shift were to mandate placebo use in all vaccine trials, even where active comparators might be more appropriate, we'd likely see significant impacts on both design complexity and timelines. First, ethics boards may push back. If an effective vaccine already exists, withholding it in favor of placebo could be viewed as unethical. This leads to delays, extra review cycles, and potential public concern. Next, placebo-controlled designs often require longer follow ups, which can prolong timelines by months or even years. Lastly, these designs are frequently more difficult to recruit for, patients and parents may be reluctant to participate if there's a genuine chance of receiving no active protection. If policy does shift, having tools that can adapt trial design without compromising data integrity or patient trust will be essential.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, discusses findings from the report and the identification of current challenges being faced by the industry.

Implementing Virtual Models in Clinical Trials: Results from PicnicHealth’s Annual State of Observational Research Report

, Rachael Higgins, chief commercial officer, PicnicHealth, discussed the company’s recently released 

2025 Annual State of Observational Research Report

. She highlighted some of the key findings including the persistence of more traditional research methods as well as how patient retention and incomplete data are creating challenges for the industry.

ACT: Could you tell our audience a bit about the 

 and highlight some of its most noteworthy findings?

The research report that PicnicHealth ran basically shows that the industry is definitely at a turning point. The stats show that 80% of the leaders that we interviewed are either using or they're open to virtual models. I think the exact number was 78% and I think this is happening because they are number one, getting pressures from the regulators, payers, and patients for number one, real-world data. They also are leveraging AI and tech-enabled solutions to be able to deliver this in a more systematic, efficient way. If I look at all the stats that were out there, I think one of the major stats that came out is data completeness, and this is the industry's biggest hurdle, 64% of them said that incomplete data is their top challenge and if you think about traditional methods, like a site-based study or a traditional chart review, it just isn't able to deliver that data completeness or capture the entire patient record, if you will, which is why they're actually looking for other options for that. Another area, which again, is no surprise, is patient retention, the loss to follow up with any trial, is one of the biggest issues for life science partners, and they are looking for ways to actually solve that, so having a direct connection to the patient is one of the ways that can increase keeping patients engaged, which then, in turn, would, obviously, enhance the retention. Another thing that we highlighted was 60% of leaders actually flagged that long-term follow up studies was a top priority for 2025 and we know that there are so many pressures and demands on life sciences with all of the cost-cutting measures that are happening, so they're looking for innovative ways to do that. Then last, but certainly not least is AI. If you think about some of the releases from JP Morgan, if you think about some of the questions that folks had answers with our survey, they are having a lot of pressure to leverage AI, not because it's the fun thing to do, but really because it is an innovative, efficient way to really be able to hone in on what it is that you're looking for and then get those answers really quickly. I think 61% of them are either using it or open to actually being able to do that.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, discusses findings from the report and the industry's willingness to adopt technology.

In this video interview, Cameron Breze, product manager, Inovalon, discusses current challenges with patient recruitment and how a combination of technology and manual effort can help improve efficiency.

Modernizing Patient Recruitment

, Cameron Breze, product manager, Inovalon, discussed challenges in patient recruitment for clinical trials. Traditional recruitment methods, such as manual outreach, are now less efficient due to accessibility issues. Breze highlighted technology as a way to address recruitment challenges, which can be leveraged to automate and streamline processes, reducing labor intensity and errors.

ACT: Patient recruitment has been a challenge in the industry for some time, but what are some more specific paint points around recruitment the industry is currently dealing with?

With respect to patient recruitment, there are quite a few things to keep in mind when it comes to where the industry trends are heading. As you know, there are more and more initiatives to diversify and increase access to a lot of clinical trials that have been not available to certain populations in the past. The efforts there are very well intentioned, and we're doing everything we can to structure structurally support those changes. With that said, all change comes with different challenges and barriers to growth. With respect to recruitment, traditionally, you would have maybe an academic medical center or a clinical research site reach out or speak to patients, where they come in with a particular condition. There might be a team of superstar researchers that reach out and say, person to person, “Hey, would you like to participate in this trial,” which is a manual effort, and has had success in the past, and will always be a part of recruitment efforts, that said you miss out on a lot of the population if you don't consider, say, the people who couldn't afford to go to the doctor that day, but have that condition or are busy at work and can't actually make the follow up appointments for that recruitment, so weaving in ways to incorporate more flexibility in those clinical trial offerings is a way that we can continue to diversify and expand that range of patients who are recruited. Then beyond that, there are more atypical and more complex trials that are available. In the past, where you might be testing an antibiotic or something to treat your blood sugar, regulate your blood sugar for diabetes, some of these are trials are for very, very specific types of cancer or genetic diseases that may manifest over time, so the barrier to entry in terms of getting a patient to the door who's willing to participate in the trial exhibits all the characteristics that are required by the protocol for the inclusion and exclusion criteria, can be quite a challenge. It's always going to be a combination of manual effort, and now more so than ever, we're leveraging technology to simplify and automate and follow up with these patients where it would be too labor intensive, too time intensive in the past.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, discuss how newly emerging data from patients can help the industry improve its recruitment strategies. 

Leading with the Patient Voice

, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, discussed results from the Barriers in Clinical Trials survey conducted by StuffThatWorks. Key challenges identified by the survey include lack of physician communication, patient education, and the complex recruitment process. Elish and Ross highlighted how the findings can be used to streamline processes and leverage patient data to improve clinical trial recruitment.

ACT: What implications will the Barriers in Clinical Trials 

 results have on the clinical research industry?

We've known for decades that patient recruitment is the number one challenge with clinical trials. We talk about the data, we see the data. We now have data directly from patients through the StuffThatWorks platform where you can engage with patients directly that are saying, “I, no matter where I live, want to participate in clinical trials. I have a need. I've exhausted other avenues. My physicians are not bringing these opportunities to me. When I raise it, physicians will impact the way that I view the clinical trial.” We have enough data now and enough direct patient insights that it is time for us to change how we're running clinical trials. It is time for us to lead with the patient's voice and restructure the way we conduct clinical trials. Looking at it through the lens of the patient, I want, and I believe and trust in my primary I want opportunities, no matter where I live, to clinical participate in clinical trials. It's upon the industry to solve for that, and the time is now.

: I second that very much, and I think that one of the biggest problems is the disconnect between access to patients and access to patient data. There is a total lack of access to patients. Every time you have to recruit patients from scratch, there's no way to really identify or advertise to patients online, because Google, Facebook, they self-regulate, and then you have to screen patients all over again because you don't really have their data. They're coming without data, so they have to be screened, and then their medical records have to be downloaded, and the information and screeners and the whole process. If you have access to patients at scale, and together with their data, this is a kind of game over, because you now know already who is eligible, you know where, and you just need to reach out to them and as we said before, I think, be in a respectful, ongoing conversation with patients and be involved. Have the primary care physician, the doctor, the immediate doctor be on board with the process, because that's probably the key issue here.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, talk technology and how it can save time in the recruitment process. 

Streamlining Patient Recruitment with Technology

ACT: How can key stakeholders in clinical research better educate and engage their patients?

You have to also remember that for a very significant number of patients, the severity level that is reported and the level to which it interferes with their personal lives is very significant, so they can be treated as ordinary people. If it's difficult for a person that doesn't suffer from a chronic condition, to change the their daily lives and accommodate something, then it's even way more difficult for someone who is suffering from a chronic condition to do that, let alone the process itself, the hurdles that you have to go through, the number of people that you have to talk to during the screening and after the screening, and this whole hand holding thing, which is, again, not ideal, and is causing a significant percentage of people that could have participated and are eligible to participate to end up not participating because they haven't been hand held properly throughout the process. There needs to be a much smoother process in which someone is identified, communicated to onboarded, their data is onboarded, the whole thing needs to be brought to the next level in terms of both technology and optimizations. I always think it's very funny that, when I started StuffThatWorks also, that in every other aspect of our lives, other than health, everything is so optimized to be convenient for us, so that we end up buying something or whatever you have, you have all this data about us, everything is data driven, everything is optimized, every piece of the funnel is polished to maximum, and when it comes to health, and it's along everything, along the way in every little aspect of fragmentation is huge, and clinical trials is also just one of these reflections, but it's interesting, because in clinical trials, this is where the interest would be aligned, because financially, the amount of money that is being lost every day of delay, which is usually caused because of recruitment is enormous, so here, at least financially, you're supposed to have alignment of interest, and it's, it's not actually happening.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, discuss how industry can improve on truly understanding the unique circumstances of patients. 

Strategies to Improve Patient Engagement

I'm sure there is, and it starts with leveling with having an ongoing conversation, ongoing education, and ongoing relationship with patients. You don't arrive out of nowhere. We're just throwing a little ad that says not much, very, very limited, and expecting people to be all over you, in participation into clinical trials. There are financial aspects. There are many opportunities to educate—not educate, I really don't like this word—but to expose, to talk about, to explain to in a way that is really leveled, patients understand. We know from StuffThatWorks, that patients are extremely educated. They know everything about their condition. They know everything about the treatments. They know in many senses, much more than the industry and the doctors gives them credit and I we're happy at StuffThatWorks to also transform their experiences into data that can arm them to become even more educated patients, but at the end of the day, the industry has to be more respectful to patients in how it approaches and how it communicates, and be more modest in expectations from patients.

I would just add that, I think we have to engage the patient with where they're at, so often we want to bring a patient into a trial, and we're trying to meet the inclusion/exclusion criteria and find the cookie cutter, but that may indeed be one of the biggest challenges with patient recruitment is we're asking them to create a whole new way of behaving to get into the clinical trial. I have to go to a different doctor. I have to behave differently. I have to, go to different places, a different place to get my blood drawn, my CT scan, my whatever it might be, we put all this burden on the patient. Then secondly, as a patient is interested in a clinical trial, do we not only ask them to behave differently, we ask their primary physician to behave differently, to say, “Yes, I support you. Go do that.” Almost like, “I can't help you with anything, therefore, go and do the trial.” Part of me says if we can solve for those two factors, how do we allow that patient to stay in their normal community while participating in the clinical trial? How they can still maintain their relationship with their primary even though they're in the clinical trial. Those are different engagement parameters that we have to solve for as we go forward, if we're going to solve for this patient recruitment challenge.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, address the challenge of patients not being informed of clinical trials by their primary doctors. 

Accelerating Drug Development with Faster Patient Enrollment

ACT: Considering the findings from the Barriers in Clinical Trials 

, what are some new opportunities for medical research to accelerate drug development?

think that when you think about the number one challenge that we still face—and we've been facing it for decades—is enrollment into clinical trials. What will accelerate drug development is faster enrollment and then when you put these survey results that say physicians are not discussing the options of clinical trial with their patients, you now need to ask, how do we solve for that? You've got many patients across the world who are very, very interested in clinical trials. Many of them have—and the survey data called it out—exhausted their clinical recourse in today's standard of care, so you've got this whole patient pool that is seeing their private practice physicians and yet struggling to get to clinical trials and we have to solve for that as an industry.

Clearly, patients are also stating in the survey, and I think it's very natural that they rely on their doctor, and that the doctor's opinion of the clinical trial—we're talking to them—will be very influential in their decision to actually participate, or to try and take part in the clinical trial, also education in general, education by physicians, and general education, information and communities, so it seems it's very clear that on the onset of things, patients have exhausted treatment options. They know what clinical trials are, 82% say that they know what clinical trials are. The vast majority have never been spoken to about participating in the clinical trial, and they want to get any education on top of that. In numbers, it's all about funnels at the end of the day, right? You have the number of patients that are getting in the gate towards participating, and then the screening process, and then the locations of the sites that are limited, it's not everywhere, and every such step of the way, especially if you start off with the fact that 80% of patients will not be exposed to the clinical trial because of their doctor and not supported, you will see where the funnel is going, and you will see why at the end of the day, pharma is struggling with recruitment.

Recruitment

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