The following Insight is a featured article from WCG’s 2025 Trends & Insights Report. If you would like to read more insights from this report, please click here.

As we enter 2025, clinical research sites face an increasingly dynamic and complex environment. In the recently released WCG 2024 Clinical Research Site Challenges Report, we collected data from a variety of sites on the headwinds and obstacles they faced in 2024. Notably, the operational challenges sites face due to the increasing complexity of studies and the obstacles in the study start-up process, resulting in lengthy timelines, emerged among the top five trends. The operational and strategic choices sites make this year will define their ability to thrive in an era of adaptive trial designs, cutting-edge therapies, and heightened expectations for efficiency. 

Study Activation: Breaking the Barriers 

For many sites, the gold standard of study activation is the National Cancer Institute’s recommended 90-day “time to activation,” which is defined a bit differently by each institution. Even for sites not conducting a large volume of oncology studies, most sites target 90-120 days for their end-to-end start-up timeline. Often, looking at the median time to activation can be most helpful when understanding where a site currently stands but may lead to further investigation into outliers in the upper range, dragging down the overall average. So, how does a site prepare for a high degree of accountability in this ever-changing landscape?  

When it comes to complexity within the start-up process, few trials set the bar higher for sites than cell and gene therapy (CGT) studies. In the coming year, clinical trials involving CGT products are expected to play an important role in the development of new therapies in an expanding range of therapeutic areas.  For example, some CD19-directed therapeutic approaches developed for hematology/oncology indications are being repurposed for the treatment of autoimmune diseases, such as lupus, and many of these clinical trials will begin in 2025. 

Sites wishing to prepare for CGT research can take a variety of approaches. Any sites looking to become involved in CGT clinical trials should have an Institutional Biosafety Committee (IBC) registered with the NIH. Although approaches involving the manufacture of autologous cellular products can require a large investment in facilities, staffing, and training, many other CGT approaches can be undertaken with relatively small changes to equipment and procedures. For trials involving complex manufacturing and clinical management, new sites may wish to partner with larger, more experienced sites to enroll subjects in a “hub-and-spoke” model.   

Aside from the regulatory consequences, we have repeatedly seen the impact these challenging trial designs, like cell and gene therapies, can have on study start-up. A seemingly straightforward schedule of events can cascade into a web of extensive start-up tasks that impact the overall activation timeline.  

The operational complexity of CGT trials, for instance, often requires large, multi-disciplinary teams with expertise in areas like advanced storage solutions, patient-specific customization, and specialized clinical protocols. This complexity can lead to longer trial start-up times as every step builds on prior activities, impacting the activation timeline and trial readiness. And in advanced therapeutic trials, start-up challenges are compounded by regulatory hurdles and site selection requirements. CGT trials in particular are known for their lower throughput compared to traditional trials due to the bespoke nature of the therapies. 

For example, a single line item in the schedule of events, such as “patient assessment,” can expand into numerous detailed entries in a Medicare Coverage Analysis (MCA). When closely examined, this single procedure can encompass a wide array of specific tasks and requirements. For instance, a “patient assessment” could be parsed into distinct components like physical examinations, laboratory tests, imaging studies, and specialist consultations. Each of these components then needs to be analyzed in terms of cost, frequency, whether it qualifies as routine clinical care or a research-specific expense, specific billing codes, compliance with Medicare regulations, and which entity — sponsor or payer — bears the financial responsibility.  

Often, however, the sponsor-provided budget aligns differently from this detailed breakdown, as sponsors typically base budgets on overarching categories, overlooking the specifics uncovered during the MCA process. This budgetary misalignment can necessitate additional financial negotiations and adjustments, complicating the initial planning phase and extending activation timelines by weeks or even months. 

Integrating the MCA and final approved budget/Clinical Trial Agreement (CTA) into a Clinical Trial Management System (CTMS) presents another layer of complexity. Harmonizing the study calendar with the financials becomes a meticulous task, requiring an accurate reflection of every line item to ensure clinical and financial schedules match. Any discrepancies in the system can lead to budget inaccuracies, compliance risks, and logistical challenges. Consequently, this rigorous process underscores the necessity for meticulous coordination and continuous communication among all stakeholders to achieve a seamless start without significantly impacting study activation timelines.  

Budget Negotiations: The Hidden Bottleneck 

One specific piece of the process we’ve identified as typically having some of the greatest flexibility — for better or worse when it comes to the overall timeline — is budget negotiations. They are often the rate limiting step that extends start-up timelines beyond intended targets. Given the total dollar figures represented in many clinical trial budgets, this isn’t a surprising fact on its own.  

The “white space,” which we define as the unproductive time spent between active review, is a significant factor in extending the budget timelines. This is the time spent with any party waiting for approval, sitting in someone’s queue for review, or waiting to schedule a follow-up call.  

We see that negotiations take 5-10 hours of active effort for a site negotiator. Allowing for a similar amount on the sponsor’s side, that is 10-20 hours of total effort for a process that can often extend 9+ weeks. In that scenario, the budget is actively being worked on for less than 6% of the time over those 9 weeks.  

For organizations looking to reduce start-up timelines, the goal becomes clear: focus on reducing the white space. Each party can control a portion of this by limiting their own response timelines. Beyond that, you can influence white space on the other end by making it as easy as possible for the other party to review. Providing upfront justification, using standard editing practices like color coding, and employing a clean-as-you-go approach can all help eliminate confusion and prioritize your budget in what is often a large queue.  

Most importantly, know your limits and communicate that early. It’s common to see parties prolong negotiations but then agree to a budget on day 100 that isn’t materially different from the budget offer on day 50.  

The intricate network of activities involved in clinical trial start-up highlights the importance of meticulous planning, detailed analysis, and ongoing coordination among all stakeholders. Successfully navigating these complexities is essential for timely study activation and overall trial success. Through continued process reviews, stakeholder collaboration, and effective communication, the potential delays in study activation can be mitigated, paving the way for a seamless and efficient trial. 

The Human Side of Research: Supporting Teams 

Though we focus heavily on the metrics and data of what we do as an industry, we’d be remiss not to acknowledge the softer side of research. While serving participants and prioritizing their health is the north star of our work, so must be the wellness and health of our colleagues. While the impact of the Great Resignation has diminished, the risk of site staff burnout is real so supporting and equipping a high-performing team for success is critical to site excellence and individual motivation. 

Developing team camaraderie requires taking the time to develop an environment of trust where members feel valued and connected to each other and the goals of clinical research. This is the “secret sauce” that can propel a site from being adequate to high performing. All too often it is expected that as professionals we will naturally come together as a team and foster motivation in each other. Yes, sometimes that occurs organically and with a little extra work, but attention is generally required. This means having meetings with explicit discussions about building mutual trust – based on open and honest communication. The leaders at the site need to share challenges and mistakes and be willing to seek help and ideas from staff. This type of vulnerability demonstrates from the top down that team members are valuable. This type of safe environment will empower your team to act decisively and collaborate.  

Making sure there are some enjoyable “outside work” activities for team members to enjoy will also help to create a strong team. These activities do not have to be grand in nature. More casual outings can accomplish the goals of increased social interaction and recognition of team member accomplishments. The very nature of our work in helping to develop medicines, devices, and other treatments for diseases is compelling and should be reinforced as a part of your team’s development plan.  

High-functioning teams deliver better results and enhance a site’s reputation, making it more attractive to sponsors and top talent. Ultimately, this balance between operational excellence and human connection will define the most successful sites in the evolving clinical research landscape. 

The post Elevating Site Preparedness: Trends and Strategies for 2025 appeared first on WCG.

While often overlooked, understanding how patients will enter the study is the first step in developing a successful recruitment strategy to identify potentially eligible patients. The referral pathway can be internal to the research site through electronic medical records (EMR), through physicians within the same healthcare organization (HCO), or externally through physicians outside the HCO.  

Internal referral pathways using EMR are the easiest means to identify potential patients, but it takes time and experience. Building a comprehensive query within the EMR can be challenging due to limitations of the platform and experience of the research staff. Entering complex eligibility criteria commonly found in oncology studies often requires medical record “superusers” to build algorithms for capturing the appropriate patient population. It takes ample resources with the required expertise to properly query the site’s EMR to obtain a list of highly eligible patients for review and potential enrollment.  

A properly managed referral pathway continues to the enrollment stage of recruitment. Once highly eligible patients are identified, ensuring they are informed and engaged is critical to successful enrollment and retention. Building a rapport and solid foundation for communication requires patience, understanding, and time. There is a heavy focus on the administrative components of clinical research and the increase in those requirements. The administrative tasks completed in the background are essential to maintaining regulatory compliance but may cause study teams to sacrifice the time needed to build relationships with enrolling patients. Assigning a designated team to address administrative and compliance requirements is impractical for most research sites. Collaborating with a vendor can ensure potential research participants are well-informed and engaged while also supporting administrative and regulatory compliance.  

As complex eligibility requirements continue to be a component of clinical oncology research protocols, developing a strong and comprehensive patient recruitment plan is the first step to mitigating patient identification and enrollment barriers. Utilizing internal resources in combination with the right external partners can help research sites continue the drive forward in conducting clinical research and propel oncology treatments to the next level. 

Related Insights

Site Efficiency

2023 Clinical Research Site Challenges Survey Report

Whitepapers

Series: WCG Talks Trials

Unlocking Site Potential: Reducing Site Burden and Enhancing Clinical Trial Efficiency

Podcasts

The post Patient Recruitment Barriers in Oncology appeared first on WCG.

About this episode:

In episode two of WCG Talks Trials, we are joined by two WCG experts to discuss overcoming common enrollment challenges and how DE&I, technology, and protocol design factor into enrollment success.

Listen in as we delve into the critical topic of common enrollment barriers in clinical trials, how to improve enrollment by focusing on DE&I efforts, the importance of site-centric and patient-centric technologies, and how thoughtful protocol design plays a significant role in enrollment success.

Speakers:

• Jamie Harper, MHA, CCRP – Vice President, Site Solutions & Engagement at WCG
• Tyler Bye – Director, Site Solutions & Product Strategy at WCG

Episode Transcript

Dawn Sauro:

Hi everyone. I’m Dawn Sauro and I’m thrilled to be your host for today’s episode on the topic of overcoming common enrollment challenges in clinical trials. Before we dive in, let me remind you to subscribe to our podcast and follow us on your favorite listening platforms like Apple Podcasts and Spotify, so you never miss an episode of WCG Talks Trials.

We are joined today by two WCG experts, Jamie Harper and Tyler Bye. Thank you both so much for joining us today. Before we get started on today’s interesting topic, we would like to start all of our podcasts off by getting to know our guests a little bit more. My question for both of you today is, how and why did you come to join the clinical research industry? Let’s start first with Jamie.

Jamie Harper:

Hi. Thanks Dawn. Thanks for having me here today. My story really begins in the lab as a clinical laboratory scientist and in the laboratory I was really focused on the hematology department working very closely with our St. Jude Clinic and Children’s Hospital. So being on the diagnostic side of leukemia and other blood disorders, made me really think, how can I help them feel better? How can I prevent some of these things from happening?

And that led me down the clinical research world where I became a clinical research coordinator for our local oncology practice. And at that private community oncology practice, I worked my way up to the director of clinical research where I was there for about 13 years. So bringing that site experience, WCG has been very helpful. And my pathway was really convoluted. It wasn’t a direct lab to clinical research path, but it really did begin in that laboratory space.

Dawn Sauro:

Thanks, Jamie. Impressive experience. Now over to Tyler.

Tyler Bye:

Thanks Dawn. And I echo Jamie sentiment. Thank you for having us here today. So my background really in clinical research, it’s all I’ve ever known on the professional side. Going into school and into college, I was one of the many people who go in knowing they want to go into the healthcare field, but not really knowing where.

I took the pre-med track, did all of the bio and all the chem courses, realized that being in practice wasn’t what I wanted to do. But had the great opportunity right after graduating of becoming a clinical research coordinator at the University of Wisconsin Madison Cancer Center. Being there part of the radiation oncology team, running trials, working with patients day in and day out, and really getting to learn about an industry that it’s the biggest small industry out there.

And I’ve been able to grow in the industry, grow my career, working both on the site and then on the sponsor side. And now here with WCG for coming up on 10 years, I’ve been sitting in this really unique position working with all sorts of clinical research, all sorts of sponsors, all sorts of indications, and really understanding how we can help accelerate the efforts of recruitment and ultimately getting therapies to patients faster.

Dawn Sauro:

That’s great. Awesome experience as well. And really interesting to hear you both have interest and passion in oncology, which is an area that interests me a lot as well.

So now we can dive into our topic for today’s episode, overcoming common enrollment challenges in clinical trials. Can you discuss the main obstacles organizations find and hard to enroll studies?

Tyler Bye:

I’ll jump in on this one. So I think we’re in the unique position. Jamie and I both get to speak with sponsors and sites all day out every day to understand what they’re going through and understanding that enrollment. Well, it seems simple to have somebody join a study. There’s a lot that goes into it. There’s a lot of work that happens.

And I think one of the pieces where we see this day in and day out is competing studies, competing trials that are out there. We know that there are a lot of different organizations, there are a lot of different interests and a lot of different reasons why certain indications have a lot of different studies that are competing. We know that a patient is being offered multiple studies, but they have to choose one. And what we commonly hear from sponsors is that why is it their study not being chosen? Why is their study not enrolling that patient? Why are they potentially looking at another one?

And as we hear about that, there’s a multitude of reasons why, but it really comes down to understanding how do you overcome those pieces as well. I know we’re going to talk about a lot of that. But I think the idea that the clinical trial landscape is always growing. That piece of itself is definitely a challenge for a lot of the industry.

Jamie Harper:

And I think it’s a common misconception that one study site is just doing one trial and that indication, and that’s just not the case. And it often comes down to a question of, if you have multiple studies in the same indication or the same area, the question becomes, do I choose a study that’s easy to conduct but doesn’t pay as much, or do I go with the sponsored study that is a little bit more difficult and more time-consuming, but they pay more? So what’s the priority? Is it the bandwidth and the time and the patient need or is it the financial need in order to keep the doors open at the institution?

So I think that’s a very common push and pull that we see at the sites. And I also think with that, the recruitment plan is very important. And one of the issues that I saw from my site was, at the feasibility portion we would have a recruitment plan in place in order to really determine if we can even conduct this study or not. But then the SIV and site activation may take 6, 7, 8 months, and by that time, the recruitment plan is now out of date.

And the time that had been allocated to do the recruitment plan in the first place is now taken up by other studies that are coming through. So being able to reinvest that time that was spent in the recruitment plan in the first place is no longer available. So that study tends to get pushed to the side. So those recruitment plan development to activation, that timeline is very important.

Dawn Sauro:

I know one of the things people talk a lot about is referrals. And you touched on something that triggered this in my mind, Jamie, is that a lot of the times physicians don’t want to lose the patients from their practice for them to be referred out to a research program at another facility. So how would you suggest that folks overcome that challenge and make sure that the patients that could benefit from the trials are perhaps referred away, but maybe that practice still is able to stay involved?

Jamie Harper:

I think part of the reason for that is lack of information. The physician who’s referring needs the information of what the study entails and reassurance that the participant will come to that research site for the research conducted visits. They’re not usurping that patient over into their patient population.

So I think giving the information about what the clinical trial really entails and really developing those relationships and partnerships and collaborations to build that trust between the physicians is important as well.

Tyler Bye:

And if I can add onto that, I think something, when you talk about referral physician networking, it’s one thing to present the study to another physician or another doctor and say, “Hey, there’s this study available.” But that oftentimes can be forgotten. That can be forgotten in just the daily commotion of patient care.

So in some cases it does take the investigator site or that coordinator multiple times, multiple attempts to, Jamie, as she said, build that trust, build that relationship. It’s an ongoing effort. It’s not just a one time, we’re going to make you aware of this. It is an ongoing check and it’s building that relationship because I mean, that’s really what networking is at the end of the day.

Dawn Sauro:

So shifting gears a little bit and thinking about recruiting and diverse populations, and it’s along the same lines of what we’re looking for because sponsors are looking for more diverse populations, so that’s driving them to put the pressure on the sites to find that. What do you think some of the best practices are for recruiting those diverse populations that our sponsors are looking for?

Tyler Bye:

So this is a great topic in the industry. There’s a few really key areas I think that we can think about for diverse population recruiting or reaching an underserved population. I would break it down to three main areas. So you have the protocol development, you have the site selection, and then you also have just the recruitment outreach efforts and how you’re actually reaching that audience.

I think you really have to look at each of those individually to understand, they all build off of each other, but when you need to bring research to the real world population, starting with the protocol development and how it’s written to identify and recruit individuals, is a key piece. We all know that in clinical research, the protocol defines who we can recruit, who we can bring into the study.

So if the study doesn’t have parameters around it of saying we need to represent a real world population, right there you’re already presented with a new challenge just from the protocol development.

Jamie Harper:

I agree that protocol development is critically important, and having voices that represent the community as part of that protocol development is going to be key. Every population is different. They have different recruitment pathways, they have different levels of trust within the community, so it’s not a one size fits all. So having that participant voice, having that community voice from the very beginning will help mitigate and prevent any issues in recruitment down the line.

Tyler Bye:

Yeah. And as we’re thinking then about the trust piece, I’ll call on a phrase that Steve Smith, the WCG says, “The trust bears in the community.” This is a huge issue I think in research where there needs to be new investigators. We know that the investigator pool is small and there’s always new ones coming into research, but they need to have that connection with their community.

And if we can have a trust bear become an investigator and start that clinical research process with that population already around them, that’s definitely a way that we can increase the ability to bring research to the populations that really need it.

Dawn Sauro:

Great. We’ve recently done a number of site surveys and gathered feedback at WCG, and some of the biggest pain points that we’ve heard from the sites are about staffing challenges, which I think is something that we’ve been talking about for a number of years now since the pandemic started, and also the increasing level of complexity that’s brought to the sites with all the various technologies. I think we’re all trying to help sites with technology, but we’re hearing from the sites that technology and it is sometimes becoming a challenge for them because everybody does it a little bit different. So wondering your thoughts on those two topics.

Jamie Harper:

I know what the shrinking number of investigators and the increasing number of clinical trials, staffing and bandwidth is a consistent topic. And I think one of the things that I think we need to understand is that clinical research is time-consuming. And what I think some sponsors may not realize is that there’s a lot that happens. The in-between study visits, they’re not points in time. It is a continuous process. It is a continuous pathway in order to have that participant from recruitment identification all the way through to study completion.

So it’s these little nuances that each site may have in order to continue that pull through from the patient that may not get recognized in the study budget or just in the complexity of what a trial entails at the site. And that really does contribute to the staffing issues at sites or those little nuanced in-between visits, time-consuming tests that are required.

In technology I think we can… It’s really twofold. It’s technology for the research site in being able to navigate all the different technologies and portals and systems that are used for each individual clinical trial. But then also on the patient side, the patients also have to deal with that as well, and looking at smart technology and smartphones and are they even able to have internet access? Do they have the high speed internet that’s required to run this device? Are they knowledgeable about the technology? So it really is twofold on the research site and the participants involved in those clinical trials that require that high technology. And with high technology also comes high touch for those reasons.

Tyler Bye:

Yeah. I live in the product world, so the technology piece there is really true to my heart and what we’re doing. I think we live in an evolving industry. I mean, this is what clinical research has done over the years. That’s the goal is to evolve and change. With that has come a lot of new tech. A lot of new players in the industry.

One of the things I think that makes things more complex is sometimes it feels like it’s tech for the sake of tech. That doesn’t really solve problems. At the end of the day, I like to try to bring everything and research back to the whole keep it simple process. We are identifying someone, we’re bringing them to the study. We need to get them treated. We need to collect the information.

If the technologies at the site and for the patient aren’t actually meeting those goals, then we’ve overlooked some of the key pieces that actually are needed for research to continue. But yeah, as Jamie said, with technology, it’s a high touch area. Because you think of the concept of an e-diary of somebody filling out questionnaires during the course of enrollment and through the study. If you miss one of those, you might miss that notification on your phone or on your device. It may take a phone call from that coordinator to help you follow up with that. And that’s where I think with technology, there still needs to be that human element, that piece that actually brings everything back together together.

And as you’re thinking about the technology that’s going on, it needs to embolden the relationship between the site and the patient, because that patient and the site, it’s a reciprocal relationship where they’re both putting time and effort into this. It needs to be well understood on both parties, what their obligations are, what they need to do, and what really is defined as success for participation in the study.

Dawn Sauro:

Yeah. I think with the tech topic, we definitely skirted the issue of patient centricity a little bit too. So maybe we can just dive into that a little bit more. It’s a common news buzzword in the industry, but we talk on the tech piece of it but, what other advice would you give to sponsors to run better trials and to design better protocols that are more patient friendly, let’s say?

Jamie Harper:

I think Tyler really hit on it in a previous question on that protocol development and using a patient advisory board for those protocols. Not only will that contribute to the patient voice, the community voice, it will help the protocol be more friendly for those who are willing to participate in a clinical trial.

But I also think we need to think about the difficulty on the physicians, and they have the same stress as the research site and the patients do. So I think it is twofold, again, where we need to focus on the patients, make sure it’s easy for the patients. We’re not adding a new burden by high tech, high visits. Things that may not be necessary. And also the physician as well, and trying to meet all of these stringent FDA requirements, the regulations and everything they have to go through in order to get the patient enrolled. So how do we make it easy for both parties to conduct clinical trials?

Tyler Bye:

If I can add on that, just being patient focused and participant focused, I think one of the key things that needs to happen, and it goes back to protocol design, it goes back to really the site interaction with a participant. Joining a study is a choice. I mean, that is a very much a choice on the participant and oftentimes on their family for them to join that study versus other healthcare options.

The study itself, that is an offer that’s being presented to the subject. It needs to align with their motivations. And I think keeping that in mind of what is that subject’s motivation for joining that study, for being part of that study, for staying in through the duration of that study, that needs to be kept top of mind at the site and even at the sponsor side through the protocol development and execution. If we’re not keeping in mind why that subject has joined the study, you lose sight of really what it means to have that individual and their family being part of that healthcare journey in clinical research.

Dawn Sauro:

Well, I think we’ll wrap it up here. Thank you so much to Jamie and Tyler for joining us today on this episode of WCG Talks Trials. And thank you to our listeners for tuning in. We hope you found this episode insightful and that you’ll join us for future episodes of WCG Talks Trials. Bye for now.

The post Breaking Down Enrollment Barriers: How DE&I, Technology, and Protocol Design Impact Enrollment Success appeared first on WCG.

Engaging participants and cultivating trust is increasingly critical to clinical trial success, especially as trials become more complex. We need their insights.

Over the last decade, Phase III trials saw a 70% increase in procedures and a 300% increase in data collection points. These trials require more resources and personnel at a time when many healthcare organizations are trying to control costs and asking departments to do more with less. In addition,

• Only about 5% of participants enroll in clinical trials
• Only about 3% of physicians participate in clinical trials (and our five-year trends suggest that’s on the decline)
• Nearly 70% of sites miss enrollment targets and deadlines
• Approximately 15% of sites fail to enroll a single person

It’s no surprise, then, that sites are turning to outsourcing and partnerships. Collaborative efforts, such as site networks, consortiums, and partnerships with research service organizations can ease the administrative burden, allowing sites to devote their limited resources to patients and participants.

Start at the Beginning

To engage potential participants, we need to understand what motivates them to join a clinical trial. For some people, a clinical trial is a way to receive treatment—if not curative, at least treatment that will halt or slow disease progression or reduce symptoms. For others, participating in research offers them the opportunity to be part of something bigger, to move science forward, and to leave a positive legacy for future generations. Neil Armstrong once observed that “Research is creating new knowledge.” Many who participate in clinical trials want to do just that.

Create Participant Advisory Boards

Understanding motivations is merely the first step. Ideally, you want to engage patients and other potential participants in protocol development.

A patient advisory board (PAB) can provide first-hand expert insights on a disease, which can inform protocol design and execution. Incorporating participant perspectives during protocol development can result in more meaningful outcomes, reduced burden, and optimized trial processes. Yet, only 8% of protocols utilize a PAB, according to Tufts Center for the Study of Drug Development.

That 8% saw the benefits: Protocols developed with the insights of a patient advisory board had simpler protocols and more targeted designs. They reported  

• 30% reduction in clinical endpoints
• 20% fewer inclusion/exclusion criteria
• 50% reduction in the amount of data collected

Engaging your PAB in a 360-degree review of your protocol can help you identify ways to make a trial more efficient, less burdensome and more accessible.

Ensure Equitable Access

Insights from participants can help sites and sponsors

• Meet patients where they are: Academic medical centers account for 70% of trial placements. However, only 15% of patients seek care at these centers. That’s why it’s important to engage potential participants in their local communities and through patient-advocacy groups.

• Make technology accessible: For many participants, high tech will fail without high touch. For example, eDiaries, despite their benefits, can be difficult for some patients to use. Yet, hybrid trials give participants more flexibility, allowing them to have some of their visits from their home—if they can use the remote technology. Finding a balance between high-tech and high-touch ensures participants aren’t left behind in the transition to decentralized trials.

• Identify and address disparities: Considering the needs of different populations, including members of racial and ethnic groups,  those in rural areas, and the elderly, is crucial to ensure equitable access to trials. A diverse PAB can provide the insights needed to meet diversity, equity and inclusion goals.

Building Trust: Education and Communication

Retention may be even more important than enrollment: The participant dropout rate is approximately 19%, and the top reason these former participants cite is poor communication with the study site.

Communication builds trust, and trust enhances communication. This trust, nurtured by physicians and research coordinators, helps ensure participants feel involved, informed, and reassured that their questions will be answered. Put another way, participant engagement means providing the right information to the right person at the right time.

• Respond to questions: Cultivating trust begins with listening to questions and finding answers. A simple “I’m not quite sure, but let me look that up for you” instills confidence (provided the participant eventually receives an answer).

• Recognize the importance of every interaction: Each encounter with an investigator, a clinical research coordinator or other staff member is a decision point for the participant. “Am I, based on this particular encounter that I have had today, still willing to participate in the clinical trial?” That’s a decision that the participant makes every time they come in for a visit or interact via video or phone.

• Provide accurate information: This takes on many forms. It could involve explaining when and why a placebo is used or correcting what a potential participant heard from a friend who heard it second hand. Communicating clearly and accurately about clinical research—and correcting misinformation–isn’t just about convincing someone to enroll or bolstering retention: We’re building disciples of clinical research by giving the correct information for the participants to be able to spread the word.

• Be transparent: Timely communication of trial results to participants reinforces the impact of their contributions and can provide closure. Sharing these results—positive or negative– with the public is also essential to fostering trust in clinical trials.

Participant engagement involves understanding why a person is participating in the trial, providing them with the information they want and need, and soliciting their input in trial design and execution. Clear communication before, during and after the study can bolster enrollment and retention. It also fosters willingness to participate in additional studies. Remember, we’re not just enrolling participants into one study: We’re continually building trust in clinical research.

WCG is accelerating research and improving lives, together. Find out more about all of WCG’s solutions for both sites and sponsors & CROs.

The post Trust Between Participants and Sites Starts with Engagement appeared first on WCG.

Site Augmentation

What are some solutions to the challenges of The Great Resignation? Obviously, managers are prioritizing. If you are operating at half-staff, where do you place your resources? Sponsors and sites leveraging WCG Site Augmentation services report feeling less burden because they were able to outsource functions to a proven provider. Here are some of their comments:

Regulatory function is one area sites are outsourcing – from study startup to initiating proper documents to submitting to the IRB. However, not every site needs the same support; it varies from site to site, study to study, and indication to indication. This variation means that support must be adaptable.

Flexible Services

There are striking differences in site support needs based on the type of trials conducted. The most significant variation is in data entry and query resolution, which can cause a massive burden for oncology sites. Also, consider study complexity – the schedule of events, sheer number of visits, and all the testing and diaries inherent to oncology studies.

We’re back to the issue of prioritization. Do you put your time into enrolling patients, only to see the data suffer? Or do you put your time into the data, only to see recruitment and enrollment suffer? Especially in oncology studies, sites want to maintain that patient contact. Along with the time-consuming consenting process, there is a compassion element, and the patient-site bond is strong. Therefore, WCG Site Augmentation is often utilized for back-end functions, accelerating site data entry and query resolution. This way, sites can continue their focus on enrollment while meeting their data submission timelines.

Another function for consideration is chart review and pre-screening, which is a prominent research function with the Crohn’s and ulcerative colitis indication. Finding those patients can place a strain on on-site resources, so augmenting helps accelerate the review of charts and pre-screening of patients while the site team handles consent and maintains patient relationships. For the vaccine area, we see the entire gamut; there is certainly an administrative piece with chart review. The need is driven by several factors, including the experience level of new team members and the personnel gaps. For some sites, WCG Site Augmentation can provide an experienced resource to assist with training – relieving that burden and allowing the study team to conduct the trial.

New Ideas

As an industry, we are rethinking how we conduct clinical research:

• We need to match the right people with the right tasks at the right times and then fill in the gaps.
• We must look at the workflows and re-visit what can be done on-site vs. remotely. Examples may include remote clinical research coordinators and regulatory coordinators.
• We can gain efficiencies by seamlessly augmenting the research team and providing needed support. Examples include IRB submissions, enrollment screening, participant retention, and data entry.
• Training is another area where we can apply new ways of doing things while offloading the site staff. Examples include training for GCP, study protocols, and general competencies.
• Technology is a significant contributor to site challenges. Sites report having as many as five different technology platforms per study; multiplying by the number of studies, a new CRC may have to learn 30, 40, or 50 different technology platforms.
• Sponsors are willing to help sites by providing support. Increasing communication with sponsors and developing the sponsor-site relationship can help relieve bandwidth issues.
• Finally, pay attention to the onboarding process. Make sure that as existing and new staff members move through their days, they still connect as a team. All team members should enjoy their work and feel appreciated.

Additional Resources

Interested in learning more about how WCG can help your site navigate the changing clinical trial landscape? Fill out the form below to chat with our site augmentation experts.

The post The Great Resignation: Its Impact on Clinical Research & Where We Go From Here – Part 2 appeared first on WCG.

Study Starts

Let’s look at Q1 of 2022 within the clinical trial landscape. Q1 was the busiest quarter for study starts across all therapeutic areas (excluding COVID trials). Notably, this quarter included quite a few Phase III trials, in addition to many trials whose timelines are being pushed out, possibly due to a lack of resources.

Resignation Rates

Today, we are seeing the highest resignation rates in health care ever, including people moving to new positions or retiring.

The resignation rate continues to trend upward (red line). What does this mean for clinical research? It means we have more study starts than ever, combined with a higher healthcare resignation rate – meaning fewer resources – than ever.

Patient Participation

Next, let’s look at subject participation in clinical trials. While the resignation rate of healthcare workers continues to increase, nearing 3.0%, the total number of participants needed for clinical trials (red line) is also increasing.

At the same time, patient enrollment rates are declining. We are seeing a 50% decrease in patients per site per month across all therapeutic areas, especially in oncology. Respiratory numbers are also relatively low, no doubt impacted by COVID. The bottom line? The culmination of a huge resignation rate + more study starts than ever + an increase in participants needed + a decrease in study enrollments = tremendous pressure on research sites.

Pain Points

Since half of the Q1 2022 study starts are in oncology, this area keenly feels staffing challenges. Note that oncology trials also require the most resources across every phase – including study coordinators and research nurses. It takes 76% longer to review medical records for oncology subjects than for vaccine subjects. Teams may have to review three or more pages of inclusion/exclusion criteria within an oncology protocol to determine a candidate’s potential. This population also takes 3x longer to consent than vaccine patients. These factors intensify timeline pressures and site burdens.

Between Q1 2021 and 2022, the most significant growth in resignation was among people aged 40-60 and those with higher tenure. Losing healthcare workers with 15-20 years of experience results in a  tremendous loss of institutional and clinical research knowledge, a phenomenon dubbed  “brain drain”. An employee with six months of experience does not have the same capabilities as a 10-year veteran, so there is a trickle-down effect on employee education with a steep learning curve. Some sites report it takes up to a full year for new clinical researchers to develop the skill level of those vacating the positions. New team members must essentially train for two jobs – learning research plus the therapeutic area.

As a result, sites report a variety of pain points and obstacles to success:

• Putting a hold on opening new studies
• Being at half-staff for study coordinators
• Having an 80-100% turnover in regulatory staff
• Losing 50% of their experienced research team
• Having 10-12 studies onboarding without a CRC available

Read the second part of this blog, where we will focus on strategies and ideas to combat these struggles and more!

Interested in learning more about how WCG can help your site navigate the changing clinical trial landscape? Contact us today to chat with our site augmentation experts.

The post The Great Resignation: Its Impact on Clinical Research & Where We Go From Here – Part 1 appeared first on WCG.