Considering Vendor Support: What Is Required

There are pivotal considerations that underpin this decision-making process of utilizing vendor support for a clinical study. Most importantly, the sponsor, study sites, and the vendor must align trial priorities. These priorities must also align with the overarching strategic vision of the sponsor.

“[At WCG] the very core of our mission is to serve, and we do that in a very meaningful and intentional manner that is driven by purpose. Again, studies are complex in their own unique way and the need of each study is going to vary. In turn that is going to dictate the type of support that is really, truly needed for a study,” says Ward.

Vendor support is a partnership, not merely a transaction. Intentional and continual dialogue between sponsors and vendors is crucial. This ongoing collaboration ensures clarity on addressing the unique challenges inherent to the specific study.

Moreover, when selecting a vendor, emphasis on study goals and operational complexities is paramount. It is important to choose a vendor that provides purpose-driven solutions, aligning with sponsor objectives, site requirements, and participant needs equally.

Deploying Vendor Support Strategically: Where to Focus

In clinical research, it’s recognized that merely injecting resources into a study can exacerbate existing complexities. However, when executed effectively, the impact of vendor support can be transformative to a study.

Central to this effectiveness is understanding the primary recruitment drivers of a study. These include the protocol, inclusion and exclusion criteria, site selection, participating countries, timelines, and training structure. Understanding these drivers delineates the type of support required and where it should be directed. Not all sites necessitate identical levels or forms of support.

“Every study manager wants their study to get support and go as fast as possible, but there are reasons to prioritize certain studies. Some sites need assistance with recruitment, or assistance entering all the data that they are collecting so that they can focus on recruitment,’ stated Lampman.

Pinpointing areas where support is most critical not only sheds light on site challenges, but also provides transparency to both sponsors and vendors regarding avenues for enhancing efficiency and better focusing resources.

“[Sites should] focus on the patient care and let the vendor supplier focus on the data entry.” expresses Thue.

By nurturing collaborative partnerships between sponsors and vendors, administrative obstacles can be mitigated, empowering study sites to maneuver through complex trials more effectively and focus on what matters most, the patients.

The post Creating Partnerships: Aligning Vendor Support for Success in Clinical Research appeared first on WCG.

About this episode:

In the most recent episode of WCG Talks Trials, we are joined by three industry experts, Amy Thue and Shelby Ward from WCG, and Russell Lampman from Merck to discuss the topic of optimizing vendor support, and ultimately the success, of clinical trials.

Listen in as we dive into feedback and perspectives from both the sponsor and vendor side of the table—for valuable take-aways and insights into how vendor support is best aligned across all stakeholders.

The post Creating Partnerships: Aligning Vendor Support for Success in Clinical Research appeared first on WCG.

The post The Basics Aren’t So Basic: Successful Participant Recruitment Requires Dedicated Time, Better Relationships, and Adequate Site Support appeared first on WCG.

This highlights the need for strategic collaboration. By understanding the interconnected nature of these processes, sites, sponsors, and CROs can better strategize and optimize their operations, leading to more successful and efficient clinical trials.

Five Elements Impacting Recruitment and Retention

1. Study team capacity: Multitasking is a myth

Effective recruitment, screening, and retention require a consistent and focused approach. Multitasking is a myth, and a potentially detrimental one when it comes to clinical trials and those volunteering to participate. Different tasks require different skill sets. For example, the skills that are necessary to identify and pre-screen potential participants are different from those required for data entry and documentation. The skill to interact with people and connect are not the same skills needed to review data for completeness.

Thus, it is imperative that study sites have adequate resources matched to the requirements of the study to ensure they have a team with the appropriate skill sets for the study.

2. Site priorities: Balancing research and patient care

WCG’s 2023 Site Challenges Survey found that 51% of respondents work on more than 26 studies at any one time, and 21% manage more than 150 trials at once. That means many sites are working across a very large portfolio of studies alongside their patient care responsibilities. Patient care will take precedence in a medical setting over trial conduct. For people wearing two hats, the care demands of the day will typically dictate the day-to-day priorities. Proper planning would expect that a portion of the workload for a study will be deprioritized on a regular basis.

Balancing study responsibilities requires a systematic and realistic approach, often necessitating additional resources or support systems to manage trial operations.

3. Protocol complexity: It continues to increase

Clinical trial protocols have become increasingly complex. While this is great for the advancement of medicine and science, it makes the conduct of clinical trials more demanding. For example, Phase II & III protocols average 263 procedures per patient, supporting approximately 20 endpoints, and it takes 10 months longer on average to complete a clinical trial in 2023 compared to 2018.¹ It’s little surprise that 36% of respondents identified complexity as a pressing concern, behind only staffing and staff retention (63%) and trial enrollment (48%). As disease demographics evolve and the focus on patient safety intensifies, this complexity will continue to grow.

Sites are scaling their operations to meet these elevated requirements and are increasingly relying on sponsors for fit-for-purpose solutions.

4. Study technology: Disconnected tools

Technology has revolutionized clinical trials and it continuously creates additional challenges for study teams. The surplus of tools used across sites, sponsors, and CROs creates a lack of interconnectedness and requires additional focus to ensure systems are updated accurately. Often, study teams are being asked to learn new tech for each study and are becoming fatigued with technology. Sites, dealing with a wide range of studies, must adapt to various technologies. What was previously seen as a positive has quickly become a pain point.

Sites are already accountable for their own systems, such as EMR and CTMS. Asking them to learn a new system per new study is a substantial ask when aggregated across 10 studies, or more. Site study team adoption of technology for a study is directly proportional to the value that technology brings and the support provided by the sponsor requiring it. When requiring a study team to utilize a new technology, sponsors should include resources dedicated to managing these systems effectively whether that is in-sourced or outsourced. In the end, the study teams need to know where to go if technology doesn’t work as intended.

5. Operational structure: Bridging the gaps

As protocols grow in complexity, sites that are otherwise well qualified to perform on a study may lack specific equipment, a core specialty, or diagnostic tools. This makes it difficult to align day-to-day site operations with the sponsor objectives. It could even mean not being able to utilize that site, potentially missing the opportunity to tap a necessary patient demographic.

Sponsors and CROs should include in their start up planning resourcing to provide the support required to fill these gaps. Such support can be the difference between a successful trial and one that fails to meet its enrollment targets.

Support, Training and Communication

Addressing these challenges requires a unified approach. Site study teams have agreed to sign up for a clinical trial and conduct that trial per the protocol. When a study also requires new technology or accelerated timelines, expecting those study teams to tackle those challenges in isolation will not yield the best results for your study.  

Begin with an open line of communication to ensure that site capabilities align with sponsor expectations. If everyone agrees and focuses on the trial’s outcome as the goal, then it becomes easier to achieve that goal when those challenges arise. And they will arise.

For some sites the solution is simply a lack of bandwidth to dedicate the time necessary to ensure successful recruitment or retention. In these cases, additional resources applied to the site may be the answer. However, for most sites the answer is more complex. It is usually a combination of factors which ultimately result in the site’s inability to prioritize a given study to match the ever-decreasing study timelines. Stretched and taxed resourcing puts even more importance on training. Every study and site need training to conduct a study. Efficient training helps studies run smoothly while minimizing staff frustration and burnout. A properly trained team is better able to set priorities and manage complex protocols. They are also able to better optimize new technology.

WCG Can Help

The demand of clinical trial volume and complexity often outpaces site capacity and expertise. As a result, many sites may experience challenges supporting clinical research.

WCG can leverage our industry experts to review your study design to provide fit-for-purpose solutions that are designed to help you meet your study objectives. We combine strategy, tailored approach, and a passionate team of professionals that are ready to help you meet your goals.

Want to learn more? Contact us today to chat with our experts.

References:

1. WCG Data Intelligence Platform & Tufts 2022 CSDD

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