CRO/Sponsor

Clinical Trial Supply Chain

Decentralized Clinical Trials

Early Phase Development

Investigative Sites

Protocol Design

Risk-Based Monitoring

Study Start-Up

Trial Design

Clinical Operations & Strategy

Diversity Action Plans

Industry Initiatives

Recruitment

Analytics

Electronic Data Capture

Metrics & Benchmarks

Real World Evidence

Data Management

CRAACO

Enrollment

Integrated Research

Patient Participation

Institutional Review Board & Ethics Committee

Regulatory

Artificial Intelligence/Machine Learning

eClinical

mHealth

Technology

News

Academy

Publications

All Publications

E-Books

Media

Editorial Podcasts

Editorial Videos

Peer Exchange

Practice Academy

Conferences

Conference Coverage

Conference Listing

Columns

All Columns

A Closing Thought

Clinical Trial Insights

View from Brussels

View from Washington

Resources

Advertise

Blogs

Events

Front & Center

Partner Perspectives

White Papers

Webcasts

Subscribe

Latest solutions, case studies, interviews, practical articles for clinical trials operations, data management, technology, investigative sites and services.

About

Contact Us

Editorial Contacts

Do Not Sell My Personal Information

Privacy Policy

Terms and Conditions

Applied Clinical Trials Online

LinkedIN

Instagram

Facebook

Youtube

Soundcloud

Threads

Spotlight

DE&I

Topic

1rem

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

Podcasts

What Can ClinOps Learn from Pre-Clinical?

Strategies for ensuring that innovation with PROs remains parallel with advancements in disease detection and progression.

Modernizing Patient-Reported Outcomes:  Bridging the Gap Between Legacy Measures and Contemporary Healthcare

Examining the implications of the recent US executive orders concerning diversity, equity, and inclusion pursuits—and the key questions each clinical trial stakeholder must now navigate.




The Impact of DEI Ban On Clinical Research Ecosystem 

The future of clinical trial design involves incorporating the patient experience into strategic asset planning.

Tapping the Patient Voice as a Strategic Differentiator

Anticipating divestment, reallocation of investments, and retrenchment.

The Hard Truth About Rare Disease and Gene Therapy Drug Development

Why investing in truly effective training from the outset can pay off exponentially for clinical teams—and serve as a strategic advantage.

The Compounding Power of Training: Early Investment Yields Exponential Returns

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, discusses how risk-based approaches must be prioritized amidst the increased demand for quality and compliance. 

Embracing Risk-Based Approaches with Clinical Trial Oversight

, Rob Jones, product manager, TMF practice area, Pharmalex, discussed challenges in the trial master file (TMF) space, highlighting outdated regulations such as ICH E6(R3). When it comes to innovation and compliance in the space, he stressed the importance of a risk-based approach, focusing on critical records and leveraging artificial intelligence for big data analysis. Moving forward, Jones believes the TMF community's collaborative nature can be viewed as a strength in navigating regulatory changes and technological advancements.

ACT: What should leaders in the TMF space be focused on the most in navigating the increased demand for quality and compliance?

There is a quote that anyone who's ever listened to any of my talks or webinars or blogs or anything. I love this quote, and it's in ICH E8(R1), I've got it written down here. “Perfection in every aspect of activity is rarely achievable, or can only be achieved by use of resources that are out of proportion to the benefit obtained.” Sounds like a Taylor Swift lyric, but realistically, what it's saying is, in order to get perfection, you're going to have to put in far more effort than it's worth, so focus where the focus needs to be. Not all records in your TMF are equal. They're not. A protocol amendment changing the fundamental part of your study because of an endpoint is far more important than the routine chit chat that you have and meeting minutes you kicked out. There's more risk at a high enrolling site that's got 1,000 patients, than there are at another site that's got one, so focusing on where the risk is and really embracing this idea of a risk-based approach, I think that's where we need to focus on. That's where we can really get to this new demand for quality and compliance and being able to say the rest is good enough. It does exactly what we need it to do. It's fit for purpose. The other thing with risk, though, we always need to remember is, I've seen people in the past use risk-based as a way to justify doing less. I think the thing we need to remember is, risk goes both ways. There's some times where the risk drops, and you can say, “Brilliant. Don't need to do as much work as I was doing yesterday. All my metrics are green. I've got everything that I need to. I've just had a call with the rest of the study team. Everything's flying through. Brilliant.” There's other times, though, when you have a bad week and the number's aren’t looking great, and at those times, you have to do more work than you thought, but balancing that being available and being able to pivot where needed, that's really what the leaders in this space need to do. I think again, going back to the AI, this idea of there's people who can really have a first mover advantage. Going to be the same here. There's going to be people who really embrace this and really make a difference to their organization, and there's going to be other people who say, “It's too risky. I don’t want to, and I'm going to check everything twice, just to be safe.” That, to me, is where really the leadership is going to be focused, and again, where quality, compliance, cost, everything that comes into it can really be tackled head on.

Videos

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, highlights recent ICH guidelines and how risk should be an area of focus as trial designs continue to get more complex.

Understanding the True Meaning of Risk in Clinical Trial Operations

 I mentioned, not only have we got these new regulations, but things are changing at a rate that we've never seen before, we can't keep up with. There was a time back in the 2010s where it felt like there was new things happening all the time with, again, bringing in a real foundational level smartphones and tablets and suddenly, internet everywhere, but we're even past that now, it's moving even faster. I think the thing is, if you look at things like ICH E8(R1) that was released the other year, that was almost like a foundation for ICH E6(R3), and it really talked about quality by design. It really talked about thinking about the holistic and bigger picture. They talk in there that if you're thinking about going to certain countries, don't wait until further on down the line, just incorporate those countries into the trials you're doing. That means that trials are going to become more complicated. Complication brings cost, and fast and complicated bring risk. There's no getting around that. Risk is a big, big thing, but again, ICH E8(R1) really built in the idea of quality by design and risk being a big part of that. ICH E6(R3) also talks a lot about risk. I think the thing that we should be focusing on from a leadership point of view, is really understanding that word, risk-based has been a buzzword for as long as I've been around in the scene. We've talked about risk-based, we've talked about these different approaches, but I think it's time for us to really think what that means. Risk inherently means the potential of something bad happening. It's our job to understand that and do what we can to minimize it. In the past, terms like fit-for-purpose, good enough, they're almost dirty words. They were sins. “Good enough isn't enough.” Actually, it is now, that is enough.

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

, 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?

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, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discusses numerous themes that clin ops can focus on to keep its trials running efficiently and effectively.  

Areas of Focus for Clinical Operations Leaders in the Current Research Climate

, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discussed the impact of recent regulatory decisions on clinical research. Funding cuts by the NIH will affect intramural research and shared infrastructure. Additionally, the politicization of diversity initiatives will affect the enforcement of action plans. Lipset also highlighted the industry’s response to these actions and what it can expect moving forward.

ACT: From a clinical operations point of view, what does the industry need to focus on to ensure trials remain efficient and effective in light of some of the recent government actions affecting it?

One theme I would say is we do need to save our sites, but in the year 2025 our attention has to be on US academic research. We can't abandon them now. We have to be a little patient with them right now, so we shouldn't start reallocating our research portfolios away from academic sites and shifting studies, in earnest, more towards private, free-standing sites, which are great ways to mix a study, for sure, but our academic sites are going to face a resourcing challenge. Many of them have hiring freezes. They're having to reshuffle a lot of their own budgets right now. It's a challenging time for them, and not a time for industry to turn away. We need them to be sustainable, and we are going to have to be an important part of that sustainability, so be patient and stay by the side of America's academic research infrastructure.

Diversity and representation investments; hopefully we've learned enough and we can continue to share enough in this space that we can be efficient in realizing representation. It still will take extra effort in planning, but hopefully we can sustain our work there, because we could do it in smarter and more efficient ways.

Certainly for clin ops friends, the regulatory environment will remain somewhat unpredictable. There are regular changes happening on websites, on nights and on weekends, and we don't have email communications or newsletters coming out that are summarizing those yet. There is a certain level of unpredictability, and that unpredictability will continue with turnover and leadership. Will turnover in leadership with the inspection community in FDA bring consequences in terms of what inspection readiness looks like? We just we just don't know yet. I would say a last call for folks will be being mindful of possible changes to Medicare and Medicaid coverage, and realizing that that has consequences for research participation. When we do coverage determinations in our protocols, and we have decided that certain procedures in the site's study budget are not going to be paid for by the sponsor, but are expected to be covered by the patient's insurance, we may have more patients who are being exposed to cost sharing or who may have coverage gaps as a result of some policy changes this year, so this is a very important year for us to make sure that we understand ways that we as sponsors can help to cover these costs, so that we are not neglecting uninsured or underinsured patients and preventing them from being able to participate in trials simply because we've done a coverage determination where we thought an expensive CT scan, MRI, or routine care chemo was supposed to be covered. We need to make sure that these patients are being kept whole, and there are some very smart and innovative folks out there that have been figuring out ways to do so.

In this video interview, Cameron Breze, product manager, Inovalon, talks clinical technology and how the industry is working to increase comfortability with its implementation.

Implementing Technology into Clinical Operations Workflows

, 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: How is technology being used to alleviate some of the current challenges in patient recruitment?

I think there's certainly some give and take when it comes to different biopharma sponsors and then clinical research sites trying to navigate their relationship in terms of what does their trial recruitment effort look like, and how is it going to change with the technology and tools that are available. I think there's always a hesitation with doctors, with clinical researchers, who are already overloaded to learn a more complex tool, a more complex software. I think with a lot of the broader, more consumer facing apps, like you think of the main social media apps, very easy to use when you're ordering food delivery, they've done everything possible to make that experience as easy as possible. I think a lot of that does not necessarily extend into healthcare, so sometimes those apps or technology can be quite difficult to use, so I think there's a an institutional hesitation from both sides to incorporate that technology just because it will send things back quite a bit in terms of how much time you need to sync and train and maintain things. That's something that industry is quite focused on in terms of building out these tools. Yes, we want them to make the impact that we know they're technically capable of making. There's also the human element of building things people actually want to use and simplify their lives, so in any way that we can automate or simplify those workflows, I think that's the focus of technology going forward.

Then again, to hit home on the point with the clinical research sites having quite a site burden, where, if you can imagine, back in the day, if you had a trial for it, with two, three, four, five, exclusion criteria with age, demographic, a particular condition, someone can pretty simply read through or query the EHR and find that information, but when you get to a trial that has the complexity of 15, 20, 30 criteria, even just reading through a list and checking off, yes, no, yes, no, yes, no, that's a pretty labor intensive process when you have to do that on a per patient basis. There are many, many opportunities for error. If you think of a big clinical research team where Person A was working on it yesterday, they're out of office this week, and then someone else is picking up the slack and taking care of their responsibilities for the next few days. If there's communication with them, that's great, but things always kind of fall through your cracks. That's sort of how things work, and having technology there protects you and de-risks a little bit and gives you a more standardized and higher quality output in terms of the research product you put forward. I'm very excited to use those automated elements and structure our efforts in a way that are more scalable, reproducible, and streamlined for everyone involved.

In this video interview, Dominique Demolle, CEO of Cognivia, discusses how understanding the patient journey from the very beginning of a study can help mitigate risk and improve patient centricity. 

Best Practices for Reducing Risk Upfront in a Clinical Trial

, Dominique Demolle, CEO of Cognivia, discussed challenges in improving patient adherence in clinical trials. She highlighted the reliability of adherence tracking methods, such as pill counts and ingestible sensors, and the need for tailored patient engagement strategies. Some potential solutions to these challenges include the use of artificial intelligence and designing more patient-centric studies.

ACT: What are some best practices sponsors can use to make their trials more patient-centric and mitigate risk even further upfront?

I think that most of them are doing what I'm going to say, and hopefully I would say and repeat, proactive thinking in terms of patient engagement. There has been in the US and Europe a great initiative like the CTTI in the US, or PARADIGM in Europe about providing some guidance about patient engagement. Clearly, from the very beginning of the protocol development, but up to and including the survey at the end about the patient experience is something that is definitely going to help, and as I mentioned, even more now that we are going to embrace an even larger diversity of patients, so for sure, patient engagement is a must. The second thing is, yes, but. Not everything fits all, so the more we are going to be able to tailor the support that we are going to provide to a patient, the more successful we will be. We have mentioned AI and machine learning that could be a complementary strategy to tactics and solutions that are already put in place, but really to ensure a higher probability for those patients to remain engaged and understand why they take the drug and understand why it is important and why it could be beneficial for them. Proactive thinking, integrated strategy, and taking the best of each solution to really map and try to tackle the problem.

In this video interview, Dominique Demolle, CEO of Cognivia, talks artificial intelligence/machine learning and its potential in gathering patient data. 

Using AI/ML to Improve Patient Adherence

ACT: Is there potential for the use of artificial intelligence/machine learning (AI/ML) to improve adherence? If so, how?

 I would say definitely, yes. When we start thinking about the adherence, the magical trick would be to be able to predict if a patient is going to be or not adherent when entering the clinical trial or at risk of dropping out or not being adherent. Of course, to achieve that, you need in your recipe two sets of ingredients. The first is to understand the drivers of the non-adherence, and the second one, because it's a multi factorial source of elements, you need to integrate that information and understand the importance of all those different elements, and then you come to machine learning and AI, so yes, definitely it is a way to move forward to better adherence in clinical trials, but you have to capture from the patient themselves. What are the triggers? And there are multiple dimensions, some traits of personality, but health literacy, for example, think about health literacy, know that we have to implement a diversity action plan. Of course, patients coming from a minority might be less educated regarding to medical support, or what is a clinical trial? Why it is important to take drugs at such a such point of time. So, per se, it's all a concept that you have to integrate in your AI model, and then all the other factors, like the motivations, the stress, some patients are stressed about adverse events and will disengage very early, so the idea would be to succeed, to integrate that information using machine learning, using the modeling, and predict a risk for a patient to not be adherent, and then you have that to engage your patient with a more tailored patient engagement strategy. This is how I view AI and how it could improve the retention, this is all what we are looking for. Patients are difficult to recruit. We don't want to screen them out. This would also cost a lot, this would not reflect real world, so we want them to enter the trial, and we want them to keep them in the trial until the end. It's really a win-win for the sponsor, the patients, the investigator, and the stakeholder.

In an interview with ACT senior editor Andy Studna at SCOPE Summit, Jonathan Norman, director, localization services, YPrime, discusses the importance of communicating with patients in their native languages.

SCOPE Summit 2025: The Importance of Language in Patient Engagement

ACT: How can effective localization strategies help sponsors address patient recruitment and retention challenges in global studies, potentially accelerating the overall trial timeline?

I think as you are engaging with these patients, it's really important to make sure your content is available in their target language. We know particularly for minoritized communities within countries, they are much more trusting and they are much more open to communication when it is in their language, particularly if you're dealing with older generations that maybe came to a particular country and maybe don't have a high proficiency in English or whatever the main language of that country might be, so making sure that you are accounting for potentially diasporic populations or additional languages that you might need in your study, is a way of ensuring that if you are looking for maybe a rare disease population, and you identify a patient that is a good fit for your trial, that you're then not held up by localization timelines or the lack of a language which you actually need to communicate with that patient.

ACT: How can sponsors ensure their localization efforts keep pace with diverse regulatory requirements while still accelerating launch timelines?

I think being aware of what’s needed in all the different countries that you're aiming to go into is really important because it allows us to prepare for the success of that trial. That's why I always advocate for a scale down approach, so starting with everything that you could possibly want for your scoping, so you can talk to your providers and get all the information that you need, what's available, what needs to be developed, and then making strategic decisions from there. Do you just not have the time to include a particular country or particular language, or is it the case of you really want to include that community, and therefore you're going to get started on that localization earlier in the process. Being aware of what's needed by the different regulatory bodies in the different countries allows us to plan from the very beginning and make sure that we're delivering what's needed without causing impacts to your go live dates, whatever it might be for your particular trial.

Latest Conference Coverage

In this video interview, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, highlights how the MMRF accelerates trial timelines for biopharmas by integrating an adaptive platform model.

How the Multiple Myeloma Research Foundation is Partnering With Biopharmas

, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation (MMRF), discussed challenges in multiple myeloma clinical trials, including inefficiency, lack of focus on critical patient questions, and underrepresentation of diverse patient populations. Andreini also highlighted the Horizon clinical trial and how MMRF is working to address unmet need in the myeloma research space.

ACT: How is MMRF helping biopharma companies evaluate their multiple myeloma therapies in trials they wouldn’t run on their own?

I'll give you a concrete example here, so our first biopharma partner in our Horizon clinical trials program is Johnson & Johnson, and we're helping them to determine what is the optimal dosing strategy for a drug called teclistamab to maximize efficacy and limit safety and tolerability concerns. This is an incredibly important question for Johnson & Johnson to answer, and it's also an important question for patients who will be treated with this therapy, so J&J could conduct this type of trial on their own, but it would take much longer, and would cost them much more than it will cost us because of this adaptive platform model that we've put into place and our consortium of research partners that we have in place, where we have pre-negotiated contracts with all of these sites, so it's a much more efficient process overall. What's attractive about it to J&J and other biopharma partners is that it allows them to more rapidly generate robust randomized control data to support again, answering the question of optimal use of their therapy than they could do otherwise.

In this video interview, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, discusses how MMRF goes beyond safety and efficacy data to help biopharmas research appropriate dosing for multiple myeloma therapies. 

Filling Evidence Gaps in Clinical Research 

ACT: Despite many new therapies for multiple myeloma receiving FDA approval, why is there a lack of evidence for how to best use each treatment?

Yeah, this is another great question, and taking a big step back, drug development led by biopharma companies appropriately focuses on proving out efficacy and safety for FDA approvals, right? And that's the right thing for biopharma companies to be focused on, but when new drugs come onto the market, that means that there's often a lack of evidence on how best to use these therapies in their approved indications, because they can't evaluate every combination and sequence and dosing schedule as part of that clinical development path to get the FDA approval, so this is where we, as an unbiased third party, as the MMRF, can really partner with biopharma companies to help fill in these evidence gaps, to inform, ultimately, what are the optimal uses of these agents and these approved indications.

Clinical Operations & Strategy

Latest News