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How decentralized clinical trial designs and smart data integration are transforming the patient experience.

Reimagining Clinical Trials for Remote Populations 

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

As clinical trials become more complex, success depends on early collaboration, thoughtful protocol design, and practical strategies to manage risk, reduce delays, and support patients.

Navigating Complexity: Strategies to Accelerate Modern Clinical Trials

Why future-ready pharma companies must embrace AI-driven, real-time decision-making. 

From Automation to Self-Optimization: The Next Leap in Clinical Trial Delivery

An article published by the Journal of the American Medical Association highlights recent updates made to the CONSORT checklist and how they ensure the accuracy of trial reports.

Improving Clinical Trial Reporting with CONSORT 2025 Updates

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.

Videos

In this video interview, Heather Horville, solutions consultant at Greenphire, emphasizes the growing need for clinical operations to embed patient-centric services—from consent through final visit—to improve retention and overall trial success.

Designing Trials Around the Full Patient Journey

, Heather Horville, solutions consultant, Greenphire, discussed the challenges of retention and trial timelines due to increasing financial and logistical burdens on patients. Horville highlighted strategies to address these issues, such as early planning, patient advocacy, and site selection based on local needs. For complex trials, engagement through diary entries and stipends, and human interaction via concierge services will be critical. Future improvements will emphasize a comprehensive patient journey, incorporating services like travel prepayment to enhance trial success.

ACT: Looking ahead, how might clinical operations as a function evolve to better support the patient experience and, by extension, trial success?

I think that it's going to be more and more important to consider the entire patient journey from start to finish, really focusing on their experience and designing engagement throughout the life of the trial, from the initial consent and what that experience is, all the way through to the final visit and that final data collection. I think that's really going to be key. A lot of in line of what we've already been speaking about, but I think it's also important for the folks, the sponsors, really conducting these trials, to plan for these services to be in play, to engage patients, incorporating what used to be known as nice to have services like reimbursement, stipends, and travel, as really a way to ensure that we retain our patients throughout the trial. We know that we should be speaking to advocacy groups, reimbursing patients, and prepaying for travel. We know this, but all of these things cost money, and the data shows that they are more and more crucial in successive trials, so streamlining these services, ensuring that we're considering the site's experience, like we mentioned before, and planning to have these services involved can really help shape trial success in the future. I think it's just going to be more and more important to do so.

In this video interview, Heather Horville, solutions consultant at Greenphire, discusses how clinical teams can boost participant retention in lengthy or complex trials through strategies like personalized engagement, stipends tied to ePRO diaries, and concierge services that offer one-to-one human connection.

Improving Retention in Long-Term Trials with Human-Centered Design

ACT: What are some best practices clinical operations professionals can adopt to improve participant retention across longer, complex trials?

Definitely, when we think of longer trials. First, in terms of length, there's a lot of time. We're hearing 10-15 year trials sometimes, so engagement for patients is going to be a really important factor to consider. How are we engaging with our patients? How are we motivating them to come back time and time again? We look at things like utilizing diary entries, ePRO, things to keep them engaged. At home, are we paying stipends when they complete their diaries each week to drive that retention, keeping them engaged? What we found to help with both longer and complex trials, both of those barriers, because they're different, is interaction with another human being and how important that is. We have something at Greenphire in terms of helping address that with our concierge services, that has a 95% retention rate, and that human interaction, that one to one relationship has been really, really impactful when we think of keeping them engaged. Really, that interaction with another human, that engagement and that motivation are going to be best practices there.

In this video interview, Heather Horville, solutions consultant at Greenphire, shares how patient advocacy, localized insights, and real-world logistics can help clinical operations teams design studies that are more accessible to rural and minority populations.

Designing Inclusive Trials: Removing Barriers for Underserved Patients

ACT: We know that rural and minority populations are disproportionately impacted by trial access barriers. How can clinical operations teams design protocols and site strategies to avoid unintentionally excluding these groups?

Now, when we think of study design, I really highly suggest that sponsors get more and more involved with patient advocacy groups, speaking to key opinion leaders, really finding out upfront what matters and how they can help, asking for feedback and what may prevent patients from enrolling in the first place, and then learning about the current climate for the different countries that they want to conduct research in, what's allowed, what's not, what is the preferred way to handle things. Once we find all this out, we can really use these learnings to design the study and inform site selection. One of the things that we may hear about in the feedback is, “How can we afford it?” Patients really ask that question. What if there are patients in this country, region, or town that don't have public transportation or ride share? I know, personally, I live in the country, I don't have public transportation within 40 minutes of a commute from my home. That's something that when you speak about rural populations, transportation is a huge barrier. In minority populations, we think of socioeconomic status in certain large cities and how that can be tied very largely to diverse groups. They have an impact when we have to think about, how are they going to take time off of work? How can they afford to do that? Who's going to watch their children? How are they going to pay for parking, meals, all of that? When we think of all those concerns, and we use that feedback, we can help design protocols and strategies, and we can help support our site to really help remove those barriers and make everyone's journey a lot easier.

In this video interview, Heather Horville, solutions consultant at Greenphire, discusses how growing financial and logistical burdens on participants are threatening study timelines and data quality—and why planning for retention earlier is becoming a clinops imperative.

The Rising Stakes of Patient Retention in Clinical Trials

ACT: Retention in clinical trials is becoming increasingly difficult, especially with financial and logistical burdens growing for participants. From a clinical operations perspective, how serious is this issue becoming for study timelines and data quality?

I totally agree with that statement. As we think of trials becoming larger on a global scale and expanding in that way, and then cost of everything these days going up, and everyone being impacted by that across the scale, it is definitely becoming something that we need to address and address sooner on in the process of planning for a trial. Statistically, we see that 30% of enrolled patients end up dropping out throughout the life of a trial, and that's overall, and the same challenges that may cause that retention also cause delays and goals not being met when we think of enrollment and diversity, so when we think of, the first part of that is, you said, study timelines. Well, if we're not meeting our enrollment goals, and it's taking a lot longer for that to happen, and our diversity goals as well, then those timelines are already very much delayed at the beginning of the trial. Then when we think of data quality, as a sponsor, everyone is investing so much time into each patient and going through the process of the trial, every visit, and if a patient ends up dropping out, when we think of all the data points and the study endpoints, and everything that we're not collecting from that patient after having really invested a lot of time and energy into that patient and their journey, then it really does impact that data as well as the overall experience. Definitely agree that it has a huge impact, and in terms of timelines, the upfront enrollment delay and then data quality, we're just not getting all the data if we can't retain our patient.

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.

In this video interview, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, discusses the most prominent challenges he is seeing in the space right now including competing research priorities and finding endpoints.

Unique Challenges in Rare Disease Research

, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, discussed the unique challenges in rare disease R&D, including competing priorities among researchers, difficulty in diagnosing and treating patients, and defining endpoints due to varying symptoms. Ansel also touched on the potential of technology and artificial intelligence to address some of these challenges and improve rare disease research.

ACT: What are some unique R&D challenges to the rare disease space that the industry is currently facing?

It's a great question, Andy. There's a lot of challenges that the rare disease space is facing right now, differences in competing priorities, whether that's between researchers, advocacy organizations, biotech companies, and even regulators, because rare disease is difficult to diagnose and treat these patients, there's sometimes differences in how do we do that? How do we handle their care? You can imagine the downstream effect that has and every other aspect of a patient's life with a rare disease. Also, finding endpoints is becoming a challenge. It has always been a challenge. A lot of the rare diseases we treat today don't have the same symptoms. We don't see the same severity of symptoms in all patients, so when you go and create a clinical program to prove that your drug is efficacious or effective and safe, regulators really look for defining data, defining criteria that prove that your drug, of course, works, and that can be really challenging when your patients have a spectrum of symptoms that go across every organ. It's hard to find a measurable change and maybe one symptom that not everyone in the patient population experiences, so I would always say that endpoints are particularly challenging in rare disease. Probably last but not least is funding. Rare is difficult because, collectively, rare is not rare, but as you start to narrow down the rare umbrella into very precision-based medicine, or grouping subpatient populations by genotype, your numbers go from quite large to very, very small and very narrow, so as you start to cut the pie, if you will, of funding to each of those groups, there's only so much to go around. I think rare disease is always faced with financial restrictions and considerations when it comes to R&D.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, discusses how an emphasis on patient centricity can encourage more sustainable trial designs. 

Sustainability by Design

, Theirry Escudier, Portfolio Lead, Pistoia Alliance, discussed the alliance’s newest initiative to assess the carbon footprint of clinical trials. The initiative aims to answer whether decentralized clinical trials positively or negatively impact carbon footprints. Escudier also discussed how clinical research stakeholders are slowly beginning to adopt more sustainability practices, focusing on reducing waste and costs.

ACT: In terms of sustainability, how have clinical research stakeholders been responding to challenges such as operational costs?

 If you start to think differently and looking to what do I need, really, in my trial? Once again, it's also part of the overall new concept, but it's not anymore really in the EU now on the patient centricity and patient engagement is, if we think, in the place of the patient, what matters for them, and it's one of the reasons we have so much concern in terms of patient recruitment. It's also well known that in most of the trials there is difficulty to recruit patients and/or to keep them in a trial, because sometimes there is too much burden. If you start to think differently, thinking more on the on the patient side, then you also start to think on the way you can design your trial. Maybe you can reduce some of the visits. Do you really need to have all those patient visits in the flow chart? Like maybe we can keep the visit, but we could have, I would say, a phone call, instead of asking the patient to cross the city, to go to the hospital, all those things, and in particular, with the technology, because now you could even have those Zoom calls, Teams calls that you can even put in place. You could also have all those new tools that you can give to the patient on those apps that will remind what they have to do, when they have to come, what type of data they have to record, so there is maybe some new ways of thinking on designing your trial, so that's what we call now sustainability by design. Instead of doing what we have been doing forever, can we think differently in maybe designing the trial somewhat differently, of course, keeping the most important, that is to say, ensuring that the safety of the patient and being able to assess the efficacy, because that's the rationale of doing those clinical trials, but maybe if you do that a little bit differently, you could act on two sides, reducing the cost in a way, reducing the carbon footprint, and at the end, it's a win-win situation for everyone.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, talks the current landscape of sustainability in clinical trials and how stakeholders are beginning to pay more attention to carbon footprint amid increasing protocol complexity. 

A New Era for Sustainability in Clinical Research

Except a few, let's say, front-edge companies, that have already looked to that domain for a couple of years, I guess most of the clinical leaders have never really considered the sustainability, because I think no one has really assessed in the past, in fact, the impact of the clinical trial implementation. Everyone is focused for decades about ethics, about safety, about regulatory compliance, keeping I would say those trials within the budget, within the timelines, make sure that patients will, I would say, accept to be part of those clinical trials, having good data, good quality, so all those things with an increasing complexity of the trials, this has been proven many times by those studies from Tufts, it's clear that the protocols are becoming more and more complex. There is more and more, I would say, demand on both the investigator side and on both the patient and everyone was focused on that, and it's only in the recent days that there was a new mindset that is appearing to say also, well, clinical trials are not equal to zero in terms of carbon footprint, and because this is an overall action and implementation, can we reduce that impact that now people are also looking and a couple of comments is, is not to oppose, I would say, the sustainability versus the cost, because, if you think also in a different manner, one of the other issues in clinical trials is the waste, waste of packaging, waste of blood samples that are not used and even they are sent to the site, some waste of the drugs even now with all the IRT system, you can really more control, I would say, the number of supplies you are sending, but still, there is a lot of waste and this waste is purely, I would say, carbon footprint, but also it's a waste of money.

In this video interview, Cameron Breze, product manager, Inovalon, highlights current trends with decentralization and how a dual approach can ensure flexibility across different therapeutic areas.

Determining the Effectiveness of Decentralization Across Different Trials 

, 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: Is the incorporation of decentralized elements and more remote trials helping with enrollment? Why or why not?

The efforts towards decentralized trials and remote patient recruitment are something that has been birthed out of recent changes in technology, but also socially and culturally, with the COVID 19 pandemic in 2019 to 2020, we really reframed, okay, how can we move research forward within particular constraints? I think it's always going to be a matter of what's the best fit. There are certain trials where that remote or decentralized approach might be best suited. You can think of, say, cream or an ointment for a skin condition where you could take a picture of it with your cell phone. There's no risk to your health in the long term. It's just something that might be visually disturbing you or affecting you mentally. Same thing with a lot of mental health conditions, where you could have therapy that's conducted remotely, or some cognitive behavioral combination of the two, plus an intervention. With that said, there are still trials that will essentially never be remote. There are a lot of more complex biologics that are being released on the market, where they're required to be administered through an IV or some other complex administration method where you have to be at a physical research site. It's not as simple as just taking a pill and then they'll monitor you and maintain that clinical connection as you move through the trial. I think it's something that people have in mind, and I think the most forward thinking organizations have a dual minded approach, where there will always be trials that are optimized for that decentralized approach, and then there are trials that will be better suited for powerhouse academic research centers and everything in the middle, because it will be quite a spectrum, and that will continue to evolve as we get new disease indications that are now accessible to treat. I'm very excited with a lot of the computational chemistry and computational biology methods that are coming out, where we can match, more specifically, to a lot of mild to moderate, genetically inspired disease and treat that through something like a biologic. All of that to say, that dual approach is what I think most organizations will take going forward, and it will continue to bear fruit, and we'll pivot and adapt as the industry moves along with us.

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