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1rem

Examining those technology-supported areas that sponsors, CROs, and sites consider the most valuable.

In Focus: The Top Needs in a Clinical Trials Software Package

Insights identify opportunities to optimize sponsor, CRO, and site collaborations.

Benchmarking the Investigative Site Qualification Process 

Clinical trial liaisons rather serve as experts in their therapeutic areas and as clinical trial specialists to provide a suite of strategic advantages to benefit a study.

The Value of Clinical Trial Liaisons in the Drug Development Lifecycle

A focus on data and process excellence advances product development.

Five Predictions That Will Drive R&D Effectiveness in 2025

How a deeper review of site budget and payment processes and technology is driving meaningful change in the industry.

Elevating Clinical Research Site Relationships With New Budget and Payment Paradigms

In this video interview, Dominique Demolle, CEO of Cognivia, discusses challenges that sponsors are currently facing with adherence and some strategies that can help address them. 

Improving Patient Adherence

, 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 challenges that you are currently seeing with sponsors trying to improve adherence? How do you think they can be addressed?

 I would say that probably one of the most important challenges is to have some kind of reliable way to manage other events and fair to say that it's really a huge challenge. If you think about, of course, some small sample size, you may have tactics like assessing the drug or metabolites level in the blood and you know if the patient has taken the drug or having some kind of, let's say ingestible sensor, for example, but as soon as you move to a larger sample size, especially in patient population, you are depending, really, on having the recording of the adherence made by the patient themselves; PROs, you may have a pill count, you may have even a device where you know if the bottle has been opened or not, but at the end of the day, you never know exactly what the adherence has been and for most, this is the biggest issue, and of course, the consequences will definitely be on your true evaluation of the track, efficacy and safety. It's really an enormous challenge, the way to some tactics that implement to address that will definitely vary significantly from different sponsors, but there has been recently tactics like having a running phase to try to predict if a patient is going to have a more adherent behavior. There are some limitations about that, we may speak about that later on, and definitely patient engagement strategy. I think we are missing some very, let's say, tailored patient engagement strategy. It’s still very general, so maybe being more focused on the individual to address a specific concern, or having a way to improve that adherence because of the socioeconomic situation of the patient, for example, would definitely help.

Videos

In this video interview, Rachael Fones, director, government & public affairs, IQVIA, discusses some of the key ways that different trial sponsors may need support in meeting diversity expectations. 

Supporting Clinical Trial Sponsors in Achieving Greater Diversity

, Rachael Fones, director, government & public affairs, IQVIA, discussed the importance of diversity action plans in clinical trials. Fones emphasized the need for understanding the intent behind goal setting, the ability to stay updated with FDA guidelines, and the importance of a robust population assessment.

ACT: What are some of the key ways that you are seeing small-to-mid-size pharmas, biotechs, and medical device companies may need support to meet expectations and make tangible progress in improving diversity in their trial programs?

So much of the work that we do in advising sponsors on diversity action plans and how to meet the expectations of the FDA in context of their overall trial goals or overall program goals, is really helping them, the individuals within the team, who are all coming at it from different perspectives, really understand not just the why from a social justice standpoint and health equity standpoint, I think everybody understands that, but what the intent of the goal-setting and the process and that truly, this is not just about the numbers, it's not just about improvement. It's about learning and it's about showing the work, putting in the effort, exploring the populations and what the impact might be, so that you can then set those meaningful goals. I don't know that you could say that this is a difference between small, medium, and large because we're all talking to individuals within a sponsored company. It just might be the difference of where that sponsor is in their journey and where the individuals are and understanding this, but it's really important to help the operational people feel comfortable that what's being set is achievable. It's helping the regulatory team that may or may not have experience on this, fit this in with other regulatory documents. This is not something that's set in stone, it is evolving. It's really marrying that. Where did the policy intent for setting goals and doing the diversity action plan come from, and then how does that work within the context of your trial? Being able to answer those questions and help the sponsors proceed with that confidence, that what they're setting is meaningful to the efforts that's acceptable to regulators and achievable for their operational teams is really a key value add that we can provide.

What we're going to see is, with it becoming required, is the volume of diversity plans will, of course, match the volume of your trial. Some sponsors may have several trials launching at once and not be able and by several trials launching once, maybe one promising product that they're trying on different populations, which will necessitate different population assessments to get to those goals or they only do one every year. Being able to utilize and tap into others who do these on a regular basis, we're able to stay on top of what the FDA is saying and what they're doing, and again, marry it with what we already know and what we're seeing, and leverage those efficiencies. That said, doing the diversity plan efficiently is great if you don't have that cross-functional team and SOPs built up to do that, but really doing it right to get your trial on the right track and bring that value-add is where I think it's really, I found, it's really helpful for us, even working with large sponsors, everybody's approaching these differently. I think we're all learning from each other, but I can say, our approach to that population assessment is really robust.

Lastly, like I said, it's a moving target. It's going to continue to change. Different reviewers are going to have different feedback. It's really important to understand those nuances, and we at IQVIA have been in a position that if we work across different sponsors, we're able to leverage those insights and deliver plans, again, that are built specifically for the sponsor in that program, yet are acceptable to regulators and implementable on the outside. Hopefully, as this gains traction, what we will see is all sponsors and folks involved in drug development start to see that value, gain that comfort with diversity planning, and it just becomes business as usual.

In this video interview, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, highlights how stakeholders can best support sites throughout complex studies.

Supporting Sites from a Lab Perspective

, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, discussed the benefits of central and local labs for clinical trials. Central labs offer harmonized test menus, standardized data collection, and global reach, ensuring consistent results across labs. Local labs, often co-located with investigator sites, provide quick turnaround times crucial for urgent patient care. In a world of complex clinical trials, stakeholders should support sites by focusing on planning, training, and incorporating feedback to streamline processes and reduce manual work.

A transcript of Aufderheide’s conversation with ACT can be found below.

ACT: Given the complexity of today’s trials and site staff being overloaded, what can trial sponsors and CRO partners do to ensure sites are supported in their work?

 I think the two key perspectives or pieces for me are planning and training. If we are planning for incorporating the voice of the customer, which in this case is the site, I know as a central lab, we do collect the site voice of customer a lot to ensure that, with all of the technologies that they're using and all of the various aspects of a clinical trial, that we're doing everything we can to make their life as easy as possible, and then just ensuring that the trial design and the way that we are designing all of the supplies that the sites are using, is as easy and straightforward as possible for them. The complexity of clinical trials doesn't really lend itself to that in some cases, so we have to get creative, but making sure that in the cases where it is a little bit more complex that where we are doing that training, and providing all of the documentation upfront that the sites need to know what is expected of them in collecting those samples and treating their patients.

In this video interview, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, touches on how therapeutic area can affect which labs a sponsor decides to work with.

Choosing Different Labs Based on the Therapeutic Area of a Study

ACT: How does the therapeutic area of focus for a trial and the related patient population steer decisions on when a sponsor should rely on central labs versus local labs?

 This is really the big key, from my perspective, on what is driving the use of central versus local labs. As we talked about in the first question, the driver, a lot of times for local labs, is that quick turnaround of testing. If you have an oncology study where those patients’ safety values have to be monitored on a regular basis, the results of those tests are going to drive and impact their patient treatment and inform patient treatment decisions from that investigator. We see a lot of local lab use in oncology trials. Those patients are very, very sick. They need those test results turned around quickly, and therapeutic areas like that, where we have a sick population of patients that are more fragile, I would say, then some of the other therapeutic areas, but that's a big driver that we see from a central lab perspective, that would drive the use of local labs for that patient care.

In this video interview, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, highlights best practices for data standardization and consistency.

Ensuring Consistency with Lab Testing

ACT: Depending on the complexities of the clinical trial, especially if it’s a global study, how do central labs help ensure data standardization and consistency across lab testing needed for a trial?

 As stated, the globally harmonized and broad test menu is really where our focus is. We have the ability to harmonize across all of our labs. IQVIA Labs has labs around the world. We are a global company. We have testing labs in many of the countries that we work in, and so having a test menu that is the same, the sponsor is going to get the same test no matter which of our labs that that test is being performed at. All of our tests follow globally harmonized standard operating procedures, and we ensure that we are harmonized to the requirements of the protocol. That's really the focus, and also the broadness of our test menu, we have the ability to perform testing across the spectrum of what could be needed in a clinical trial.

In this video interview, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, discusses the different types of labs in clinical research and what they offer.

The Roles of Central and Local Labs in Clinical Trials

ACT: What are some of the key aspects of each type of lab that are important for clinical trials, sites, and sponsors?

 In looking at clinical trials from a central lab perspective, the key benefits are really around the globally harmonized test menu, so the reference ranges are aligned, any flagging that is necessary, the data collection, the data provision to the sponsor—all of that is aligned and harmonized across all of our various labs. The central lab kit supplies, so anything that a site is going to need to be able to collect a sample is all provided, hopefully in a nice little package, depending on the central lab I guess you're working with. Really, the benefits, a focus of sponsors, and making sure that we're providing everything that the site would need and primarily focusing on everything that is needed to provide patient care, start to finish, in a collection or in a visit.

From a local lab perspective, a lot of these labs are close to the investigator sites. The investigators are familiar with them. Sometimes they are physically at the investigator site, if it's like a large hospital or a large facility. They provide fast turnaround time. The lab is within your facility, you're able to get those results quickly and inform patient care. Sometimes, in some scenarios, that can be really critical for the patients, to get those results back quickly, and just making sure that the investigator has everything that they need in a timely manner. The investigator sites also often are very familiar with these local labs. They work with them on a regular basis, a lot of times in their non-clinical trials, if they have just routine testing that they're doing, they're working with these same labs that are providing this testing for them.

In this video interview, Jimmy Bechtel, vice president, site engagement, SCRS, discusses the importance of communication between CROs, sponsors, and sites. 

Building Relationships in Clinical Research

ACT: Another topic we’ve heard a lot about recently is relationship building between CROs, sponsors, and sites. Why is this so important and what are some best practices for building these relationships?

 Absolutely, it's a good question, and one we talk about a lot actually with SCRS and our partners, because it's kind of foundational in a way that's critical to the successful execution of clinical trials long-term and building relationships. There's so many benefits that can come out of appropriately-built relationships, and so many of the issues that we see, even the one that I just spoke about with technology, can be at least moved in the right direction, if not solved by building effective relationships and communication. Even examples of your personal life and failing at relationships in your personal life, a lot of it can be traced back to poor communication, so asking and having that discussion early on in that relationship, checking in with each other on how to communicate, and developing and sticking to a communication plan is a really great way to build a relationship, and I think there's a couple of important components to that. It doesn't really help to create a communication plan, or establish that understanding if you don't use it or stick to it, so that's a really important part. Coupled with that is reapproaching that communication plan, because you're going to probably work with a completely different team at a given organization, so just because a communication plan worked on one trial doesn't mean that it's going to work on the next trial, or it might need some modifications, or again, just revisiting it is healthy for any relationship that you're trying to build. Part of that, I would say also, is being as transparent and honest as possible. If we can start to break down some of those barriers and stop treating the relationship as ‘us and them’ and more of ‘we,’ it sounds cliche, but it's still happening. We're still kind of holding our cards pretty tight to our chests and not helping each other understand, “Yeah, I am struggling as a site. Yeah, this isn't easy. This screen failure is a challenge for me. I'm not going to be able to meet those enrollment numbers” or from a sponsor, “Yeah, if you ask for that, we probably can approve it or, no, we're not going to be able to improve it for these reasons or maybe if you asked it in a different way, we might be able to approach that or consider it, or get approval for it.” So stop treating it like this hidden relationship and again, as you heard from my examples, it goes both ways. There's work to be done there by the site—just like any relationship, professionally or personally—the sites have to come to the table as well as the sponsors and CROs have to come to the table to build those effective relationships and they take work. It's not just something that you can establish at the beginning and expect it to—over the course of a couple of years—as many clinical trials go, work without a hitch.

In a fireside chat with ACT editor Andy Studna, Bowdish, from a clinical research cancer center, shares her experience with these relationships and how to streamline clinical operations. 

2024 Veeva R&D and Quality Summit: Tina Bowdish Highlights the Importance of Site-Sponsor Relationships

ACT: You’ve been in the clinical research industry for more than 25 years. Can you please tell us a little about your experience?

 Yeah, I've been in research for more than 25 years, and I have held just about every role you can in clinical research that doesn't require a license. I'm not a nurse, I'm not a physician, but I have worked at three academic medical centers now, a couple of pharma companies, and a CRO, so I have seen it from all three sides of the table over the last 25 years.

ACT: Having worked on the execution of trials and partnered with other sites and sponsors, what opportunities do you see to improve the way sites and sponsors work together?

 Communication and relationships are really the biggest area, and I think as a society, sometimes we forget that relationships are really important, especially in this work from home era where everything is done via Zoom, so conferences like this are great to be able to make those connections. It’s kind of the press the flesh, but it's reminding you that we're all serving a common goal, and we're all human, and we're all working together. One of the areas, specific into the communication, is just making sure that that communication is streamlined, it's getting to the intended audience, and then it's truly understood. That goes both ways from sponsor to site and from site to sponsor.

ACT: If there is one piece of advice you would give to sponsors to make life easier for sites, what would it be?

 The one single piece of information I could give is to truly be ready when you are approaching your sites to launch a study. It's great to go to sites before you're ready to launch that study and get their feedback, but when you're trying to initiate a trial and get that trial started, when the sponsor or the CRO doesn't have all of their individual vendors and all of their documents completed, it makes it really difficult on sites, and it only lengthens the process of our startup. If we could make sure that we are truly ready before we are approached about a study and to get started on that, I think we could significantly cut down on the long timelines for startup that exist in our industry.

ACT: In your experience in research, how have you seen the enablement of site-sponsor collaboration, and could you share any examples?

 Yeah, so it's really at these conferences. It's having these roundtable discussions and tackling issues that have been around for 25 years. They've only become more challenging with technology and trials becoming more complex, so it's really tackling how can we do this for the patient? Everything that we do has a patient or a subject at the end of the day and that is why we all got into this industry in one way, shape, or form. We had a session this morning where we talked about how can systems across different sponsors and all the multiple systems that are used in any given trial be streamlined to make it easier for sites so that we can spend more time with those subjects?

ACT: What are some aspects of a clinical trial that you can prioritize to streamline operations?

 This is a difficult question, because every study is different. As I just said, trials are becoming more and more complex. Science is exponentially getting better, but that makes it harder and harder to find patients because your populations are narrowing down. If we can ensure that we keep a patient-centric approach to designing these trials when we're in protocol development, and thinking about what are the patients or the subjects going to be doing at a given visit at a particular time, and then taking into consideration what that population is, is it a rural population that doesn't have access or stable access to internet to be able to do e-questionnaires from home, or something like that? Is it a population that has to drive for 500 miles to get to the next site because they have a rare disease? What can we do in a remote basis? What can they do locally? How do we tackle that as an industry, because who's responsible? Is it the site that's responsible? Is it the sponsor that's responsible? I think the ultimate answer is we all have to come together and we both probably need to take a little bit more responsibility in that and work towards that goal.

Latest Conference Coverage

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, touches on challenges that may be created by the guidance such as meeting multiple regulatory requirements. 

Potential Challenges with FDA’s Multiregional Clinical Trials Guidance

, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discussed the FDA's new guidance for multiregional oncology trials, emphasizing the need for diverse patient populations in clinical trials. The guidance requires companies to proactively plan trials to ensure data applicability to the US population, considering factors like patient characteristics and healthcare systems. The expected outcome is better-designed trials with broader access and representation.

A transcript of Kahsoki’s conversation with

ACT: What does the guidance mean for sponsors and other stakeholders involved in trial design?

I mentioned sites and regions in Africa, Latin America, and the potential relevance of populations there to the US population. There's a little bit of a what I think is a contradiction in the guidance in terms of what companies must do, so on the one hand, the FDA is saying, yes, you could consider expanding to those sites, it's going to help you with your diversity and your population. At the same time, the guidance is also saying you must ensure that wherever you were conducting the study, the standard treatment that's provided in these other regions is reflective of the US standard of care, so that now limits where you can go. I think as companies are considering broadening to what I'm terming, non-traditional regions, they may have to go to specific countries. A very commonly cited example is South Africa, in Africa as an example.

Then, as a last thought, the guidance does pose, I think, a little bit of a challenge if a company is thinking that it's multiregional trial will allow for a more streamlined approach, or more streamlined overall development program. We know that regulators in different regions have requirements for their populations. They too, want to make sure that the trials that are conducted have data that will be relevant to their regional populations, so those regulators will themselves impose region specific requirements, etc., so companies are left in this bind of, how do I meet multiple requirements? It could end up being that a company, depending on how strict the FDA and or any other regional authority is, that could end up being that companies have to do multiple trials, so a global trial, a mix of persons, but if that is not satisfactory to the FDA, then the FDA might say, actually, you need to do another study with a population that is indeed representative. This is why I believe the FDA says first, work through your plan for how you're going to ensure that you're pulling together a representative population and then make sure you talk to us very early on so that we can negotiate, liaise, guide you through that thinking.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discusses how sponsors will need to plan ahead even further for their oncology trials. 

Planning Ahead for FDA’s Multiregional Clinical Trials Guidance

Staying on the theme of diversity and ensuring diversity, it means that companies must begin to plan their global oncology programs much earlier than they probably were thinking, probably as early as Phase I, definitely before Phase III. In the oncology space, we know that companies are often seeking accelerated approval, so they might be seeking approval on a limited number of trials or Phase II study results, so it's important that their study population, even up to the phase of Phase II is appropriately representative. They've also got to be thinking about ensuring diversity of their Phase III trial populations, because the Phase III trials which are confirmatory and completed post-approval in the accelerated approval circumstance, these Phase III trials must be underway at the time of the accelerated approval decision, so companies must be proactively planning very early. How do we enroll an appropriately representative population for the US right as soon as possible in our program, if we're planning a global program?

I mentioned that the FDA is encouraging expansion of the types of sites for multiregional clinical trials. This, in turn, means that companies must think how we actually run these trials in a community-based site, just to keep that as the example, how will we collect the data? Often, these are not sites that have incorporated clinical protocol, clinical trial protocols, into their practice, so there is some learning first, but there's also the matter of data capture and especially in the community setting, you want the protocol to be as streamlined and as least burdensome as possible to the investigators as well as the patients, so thinking about, how do you incorporate the data capture that's happening as a matter of clinical care into your clinical trial protocol becomes an important consideration. It was interesting to me that very shortly, either before or after the multiregional clinical trial guidance came out, the FDA also issued a guidance called integrating randomized control trials for drug and biological products into routine clinical practice, and that provides recommendations on how to best collect data in a clinical trial such that it is reflective of routine clinical practice. I'm sure there was a lot of internal conversation within the FDA about how to tie all of the recommendations together, but I think for companies, when they are planning their global trials, thinking about their sites, they now have to think even further. How are we going to design the study of data collection so that it's easy to do in those additional sites.

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