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1rem

Results from survey of 100 site personnel suggest a disconnect is present between these stakeholders.


5 Strategies for Bridging the Sponsor-Site Tech Divide

Moving towards the development of mature quality management systems.

Site QMS-Based Site Monitoring:  The New Frontier for Clinical Research Excellence

It takes a village to raise a trial, but most stakeholders are siloed on isolated islands. 

From Isolation to Integration: Improving Site-Sponsor Collaboration in Clinical Trial Startup

A data-fueled framework for sponsors and CROs in navigating this shifting terrain.

The Strategic Emergence of Site Networks in Clinical Research

The role of the clinical research associate may be key in addressing challenges around the adoption of digital tools.

Trial Site Engagement Models are Poised for Disruption

In this video interview, Mark Melton, vice president of biospecimen data and operations, Slope, talks challenges at the site-level with collection.

Ensuring Proper Standards for Biospecimen Collection and Sample Tracking

, Mark Melton, vice president of biospecimen data and operations, Slope, discussed navigating data challenges in clinical trials, emphasizing the need for understanding complex data sources and ensuring a proper chain of custody for samples. Melton highlighted the importance of data mapping to standardize reporting across different labs and the necessity of secure data transfer to protect patient privacy.

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

ACT: What are some of the operational challenges with biospecimen collection and sample tracking? How can they be addressed?

 I think the biggest part is, again, understanding the multiple stakeholders. For me, I always try to go back to 30,000 feet of if I was someone in a clinical trial, I want to understand, hey, I'm coming in, I'm giving my blood or my tissue or whatever it may be, depending on the therapeutic area. I think there's often an assumption when we all go to the physician, but particularly in clinical trials, I don't think it's really well understood by the public how those are handled. The biggest part is everyone understanding that, hey, we have a location, clinical sites that collect those and again, they send them out. How do we ensure that it's interconnected, regardless of the fact that we have multiple different companies facilitating one process, so you can imagine, even in one company, it's difficult to align on process and ensuring that we're hitting that.

The biggest thing is understanding what happens at sites. If we were to break this down, there's only a certain number of facilities that will test samples, while there may be a few hundred, it’s nothing in comparison to the sites, which are in the thousands, tens of thousands even globally. All of those sites are networks, sometimes they're independent entities, but understanding what their process is. They're the point of origin, so how can we ensure that they're collecting those properly? That starts with down to the inventory, so we send out all this inventory. If you can imagine, if you're a large cancer site, for example, I'm running 600 trials. I'm just making up a number, but I'm running hundreds of trials, and all of those trials are sending me, essentially material to collect those samples. How do we manage that material and then turn that material into blood or tissue or whatever sample type, and get it out? Then how do we track that through the life cycle? What we've done is kind of crazy. The science has gotten so specific, so the concept of precision-based medicine, meaning we're going to target a specific gene or protein, the science has gotten very specific and has advanced tremendously. It's outgrown the logistics of a trial which is kind of crazy to think about, that the science, and in my opinion, the hardest part, has somehow gotten to the point where we're getting very specific in what we're targeting. Yet the process of just tracking a sample from one location to the four or five other it touches is extremely difficult. It's interesting at the end of the day, if you look, regulators are coming in and now stepping in on how you test those samples, but the gap we have right now is they're not stepping in on how those samples are tracked and reported on. I think that that's the biggest thing we have to focus on, collectively as an industry, is, how do we step in and ensure proper standards to ensure a proper chain of custody?

Videos

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, discusses the differences between working with local labs and central labs.

How Sites Work with Different Types of Labs

ACT: As it is important to take in the site perspective on their work with central labs or local labs, is there a noticeable difference in how they work with each?

 Yes, absolutely. There are complexities from a site perspective, and working with central labs, we're not the only central lab out there, and I think it would be safe to say that every central lab does things a little bit differently. If you have investigator sites that are working with multiple central labs, they are having to know from each lab perspective what is expected of them. The kits may be designed a little bit different, the way that they manage their supplies and manage their data and everything might be done a little bit different from each of the central labs’ perspectives, so that adds complexity to the site model.

Another aspect is a lot of times we see that the investigator sites have a preference for local labs because they are familiar with them. They know they're going to get their results quicker than sending it to a central lab. One of the key features of a site perspective is if they're using a local lab, a lot of times that data still has to get into the central lab database or the sponsor’s data set. How does that happen? That may be a manual data entry by the site. It may require some kind of data uptake by the central lab or even by the CRO or the sponsor, so it adds a little bit of complexity to managing the data on the back end, and then it also will tend to add some manual work on the site's side.

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, provides an overview of themes discussed and his key takeaways from the most recent summit.

Insights From the SCRS Global Site Solutions Summit

, Jimmy Bechtel, vice president, site engagement, SCRS, discussed key challenges and initiatives at the site-level. AI's impact on sites is significant, with uncertainty around its implementation. Diversity requirements pose challenges, and technology overload is a major issue due to inconsistent tech stacks and financial burdens on sites. Bechtel also highlighted some initiatives that SCRS is currently working on and gave an overview of the most recent Global Site Solutions Summit.

A transcript of Bechtel’s conversation with

ACT: The Global Site Solutions Summit was just in September. Could you tell us about some of the most relevant themes that emerged and your key takeaways?

 That's such a great event because it is our global summit. It covers a variety of different topics. Nothing is off the table when it comes to that one. We have other events like the Oncology and the IncluDE and West where we talk about narrowing in on specific niche topics. There's a lot of really great data, global-level data that’s shared around the state of the industry as it is most important to and pertains to sites, a lot of what sites need to know to continue to benchmark themselves and be really ready for the future. Where are trials? Where are you? How are you faring against your peers? What is the outlook for the industry? Ken Getz shared some really, really interesting data on Sunday at that conference around where we're headed as an industry, what trials are happening? We found that there's a need for sites and patients to meet the demand that we're going to have for clinical trials, a lot of complicated, just sheer amount and the specialization that is going to be required for some of these protocols is really increasing Seeing at an alarming rate, while the data that SCRS shared showed that, financially, sites are still struggling, struggling to keep their doors open. It paints a really important picture for us to understand. Some might consider it grim, given the juxtaposition of where we're headed with trials and where we are with the state of things with research sites, but it's important for us to understand that so we can address it, tackle it, and realize if we don't do something as an industry to address some of the challenges that the sites have and support them financially so that they can keep their doors open, we're not going to be able to meet the needs that this industry has when it comes to the conduct and execution of some of these really complicated and lengthy clinical trials.

Latest Conference Coverage

In this video interview, Jimmy Bechtel, vice president, site engagement, SCRS, discusses some key initiatives around decentralized capabilities and underrepresented patient populations.

Navigating Diversity and Digital Innovation at the Site-Level

ACT: What are some initiatives or projects SCRS is currently working on and what excites you most about them?

 The third one that I'd mentioned is the Digital Innovation Initiative. This has been a program that we've had in place since 2019, but it continues to provide innovation for sites. We produce a lot of really great things from that program, like a virtual-capable trials training, so a foundational training for sites looking to understand what it means to participate in trials where some of the elements are conducted virtually or decentralized.

We’re working now on what we're calling the Challenges and Solutions Charter. We know that there's a lot of challenges when it comes to conducting trials with decentralized elements. We spend a lot of time as an industry talking about those challenges and talking about the solutions, so what this initiative aims to do is put a pin in the specific challenges as well as the solutions associated with them, and then gain commitment from some of our partners to say, “Yes, I agree that that is the challenge and the solution to that challenge, so I'm going to commit to implementing that solution within my organization based on a timeline, a reasonable timeline that we're going to determine in this multi-stakeholder development process.” That's just one exciting new development that we're working on in that program.

Finally, the SCRS IncluDE initiative. This is our legacy diversity initiative. We are calling it the IncluDE initiative now, and they're doing some really, really great work as far as allowing sites to participate in a tool we've developed called the Diversity Site Assessment tool, or the DSAT tool. That's an assessment that sites can log onto our website and take and understand how they fare where they sit on the spectrum of their ability to recruit and retain diverse patient populations. We recently launched a sub-questionnaire related to that tool around seen and unseen disabilities, so being able to treat and accommodate patients with disabilities. Finally, we're working on a sexual and gender minorities sub-questionnaire as well, an SGM-sub questionnaire that will be sometime into the new year.

In this video interview, Jimmy Bechtel, vice president, site engagement, SCRS, highlights ongoing leadership and payment initiatives for sites. 

Solving Payment Challenges at the Site-Level

 Yeah, there's a there's always a number of different things that we've got coming out, working on, trying to listen to the site community, and build things and work on things that are going to benefit them as much as possible. There's really four things I want to highlight. We just launched our formalized mentorship program, an actual matching of a mentor and mentee. We've done this informally through a variety of different ways; senior leaders, thought leadership, providing information, putting it out to the SCRS community for those that are less experienced in various areas can absorb through tools, through webinars, the online community that we have, where the members are able to communicate with each other. Again, relatively informal, but now we're formalizing that and doing some matching. We're really excited to be able to bring the next generation of research sites into the fold, because there's such a strong need for good sites now, so having someone in your corner that you can talk to and have some candid conversations with and not be afraid to ask the questions or be seen as ignorant or uneducated in a specific area is going to really go a long way for the site community as a whole I think.

We've been working pretty avidly recently on our payment initiative. We know that payments, as I mentioned earlier, finances and site payments, continue to be a major challenge at the site-level. This payment initiative is tackling that in three different ways. We're looking at payment frequency; 75% of sites roughly, our data shows that we have as part of our community want monthly payments, yet only about 40% of sites actually get monthly payments in the end, so a major discrepancy there. We're working to break down the barriers there and find out why that's happening and how we can continue to move the needle in the right direction. I'll tell you that 40% is a lot larger than it was several years ago, which is great to see progression there, but again, still a big gap in that 75 to 40% and then finally, the issue that that group is tackling is related to the taxation of patient stipends and/or reimbursement. In the United States, any amount over $600 is typically subject to IRS reporting and is considered income, so that's taxable, and that can be a major deterrent for a lot of participants or patients in clinical trials, and their ability to do that for reasons I won't get into today, but we're working on continuing to move the needle forward there. We did make progress. Last year, they did pass an act that enabled those with life-threatening conditions and severe illness as well as certain oncology trials to be exempt from that rule, but really for it to be effective, it needs to apply across the board to all clinical trials.

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 this video interview, Jimmy Bechtel, vice president, site engagement, SCRS, highlights how sites are bearing the burdens of cost and training with implementing new technologies. 

Clinical Trial Sites and Technology Overload

ACT: One thing we hear a lot about is sites experiencing a technology overload recently. Why do you think sites are expressing this?

 Yeah, I think a lot has to do with the sheer amount and variety of technology that sites are being asked to implement on their clinical trials, coupled with the fact that there isn't any sort of standardization or consistency around it. You could have one trial from one organization use one tech stack, and then another trial from the same organization use a completely different tech stack, and that just repeats itself and compounds upon itself for all the different sponsors and CROs that a site is working with, so it's that lack of consistency and lack of interoperability and integration that has a lot to do with the challenges that the sites see. Every time they see a new technology is used in a new or different way, they have to start from scratch with the training and the knowledge and the education and how to use it and educating their patients. There's just a lot of inefficiencies that comes with this pilot-phase that we're in still with a lot of these technologies. I think we're moving in the right direction. It sounds like a lot of sponsors and CROs and professional service providers and these technology companies hear that, the dust is settling, and they're starting to understand which ones they want to use, and they're starting to build in some consistency. By now, a lot of sites have seen a lot of the solutions in one way, shape, or form, so they're starting to realize those things. It's kind of been a rough couple of years that we've tried to work through some of that.

I would also say that the financial aspect of utilizing and implementing these technologies, operationalizing them at the site level is a real challenge for sites, because there's, as you can imagine, when you have to train and implement and, again, operationalize these technologies at the site and patient level, that takes a lot of time and effort and training and coordination into parts of the site that sponsors and CROs probably never even think about. IT, and integrating that when you have a system that might be pulling data or data might be moving over that site's network and its patient data, there's a whole a bunch of cybersecurity, and IT questions that we have. It’s just one example of ways in which the dollars can start to build up in ways that we don't expect, so approaching a clinical trial with a traditional budget doesn't really work in the case of implementing technologies. Sites are seeing themselves bear a lot of these costs because they don't necessarily know either approaching some of these technologies. It's not until we're well into the clinical trial and well into that implementation phase of these technologies that we start to realize and recognize some of those true and real costs, but by then, unfortunately, sponsors and CROs say it's too late to renegotiate the budget, so the sites are stuck bearing those costs as a result of implementing that clinical trial. It’s learning the lesson the hard way, unfortunately, but that's definitely a major part of what we're seeing.

In this video interview, Jimmy Bechtel, vice president, site engagement, SCRS, discusses some challenges and trends he is currently hearing about from sites.

Uncertainty With Artificial Intelligence at the Site-Level 

ACT: What are some current challenges or trends for sites that you’ve been hearing about recently?

 AI (artificial intelligence) is definitely the new hot topic for the sites. It's not necessarily a challenge right now, there's a lot of unknowns, and sites don't want it to become a challenge and things like this tend to become a challenge. They happen at the sponsor, CRO, and service provider levels, and then the sites suffer the ramifications of whatever decisions are made at the industry level, so that that's definitely one that the sites have a big question mark around and there's a lot of discussion, a lot of thirst for information, and how is this being used? How can I use it as a site, etc.?

Then diversity, I think, is also a big challenge at the site level, knowing how to meet the needs. Even farther back from that, what the needs are going to be, what are sponsors and CROs going to be asking of sites with diversity plans and things like that? How can they be prepared to meet those? Should they be presented with some sort of diversity-level requirement—an inclusive-level requirement on their clinical trials?

In this video interview, Jimmy Bechtel, vice president, site engagement, SCRS, discusses challenges and trends he is currently hearing about from sites.

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