Clinical Researcher—October 2023 (Volume 37, Issue 5)

SITES & SPONSORS

Matt Smith

 

 

 

In today’s evolving landscape of clinical trials, the competition for trial sites with the right patients and strong retention capabilities is intensifying. Trial sponsors are striving to position themselves as the sponsors of choice by fostering collaborative relationships. This is particularly crucial in conducting research in oncology trials, rare diseases, and other high-demand therapeutic areas.

However, clinical trial sites often feel marginalized and burdened by fragmented processes, sudden protocol changes, and challenges in patient recruitment and retention. Furthermore, while new technologies, including artificial intelligence (AI) tools, are emerging, they tend to prioritize sponsors’ needs while neglecting the perspectives of the sites that are responsible for trial execution.

Based on my experience working with both sponsors and sites, it’s clear that everyone recognizes the importance of change and is eager to make it happen. For sponsors, there’s a critical opportunity to take the lead in three key areas to become a sponsor of choice.

Bring Site Representatives to the Table During Trial Design

In our industry, we prioritize the patient experience but often neglect the crucial site experience. What’s intriguing to me about this is that sites are stewards of the patient experience—they oversee patient care, facilitate data collection, and play a pivotal role in the overall success of clinical trials. Ignoring their perspective jeopardizes both patient satisfaction and trial outcomes. Developing protocols without input from those on the ground puts the trial at a disadvantage from the start, further exacerbating an already existing issue with the rising number of protocol amendments. In fact, research indicates that 57% of protocols had at least one substantial amendment, with 45% of those deemed avoidable.

Bringing site representatives to the table early has several advantages. They can help sponsors and contract research organizations (CROs) identify issues in protocol design—including considerations for specific patient populations—and provide insight into areas that could lead to deviations or problems with patient retention. Essentially, sites can act as the “canary in the coal mine,” helping sponsors detect issues in advance.

To bring sites to the table, sponsors can start by finding at least three sites within target therapeutic areas and investing in activities to foster direct relationships with them. Relationship-building efforts are crucial, regardless of whether CROs are also involved in working on behalf of the sponsors. CROs will often engage their preferred sites on a multitude of trials, so the relationship with sponsors can be less of a factor in this case. However, many sponsors, including large pharmaceutical and biotechnology companies, are already opting to maintain direct relationships with sites during the trial process.

Sponsors can further engage sites in the trial design process by providing them with the draft protocol and addressing any specific questions or concerns in a review call. Sites are experts on trial operations and have valuable insights into what will likely work and what won’t; the most seasoned site leaders have likely seen hundreds—if not thousands—of trial protocols come across their desks, so they can provide insights on what makes a good design. Utilize that expertise—they have so much knowledge to offer.

Prioritize Site-Centric Technologies

A significant portion of the technology utilized at sites aims to enhance efficiency, ensure regulatory adherence, and mitigate risks. This encompasses tools such as electronic medical records for patient records, a clinical trial management system for trial scheduling and patient visits, and others. Sites display remarkable resourcefulness, often devising a workflow solution by amalgamating various commercial solutions, spreadsheets, and in-house tech innovations. The absence of these systems can hinder sites from expanding and conducting multiple trials while effectively managing risk and compliance.

A prevalent challenge arises from the fact that technological solutions are frequently developed and chosen primarily with sponsor needs in mind, without consideration to site workflows or experience. This leads to sites grappling with a surplus of tools without streamlined solutions for facilitating their day-to-day operations. On an average basis, sites use around 12 distinct technological components in each trial. Considering many sites oversee multiple simultaneous trials, the burden becomes clearly evident.

To bridge the gap between incongruent processes that aren’t optimized for site staff, sponsors can play an active role in selecting technology tailored to site needs when evaluating vendor solutions. Inquiries should focus on the integration and data exchange capabilities of new solutions with existing site tools.

User experience is equally vital; assessing how platforms are perceived by sites and patients and engaging sites for feedback during the review process are crucial considerations. Opting for site-centric technology can bring benefits for all stakeholders—from sites and sponsors to CROs and vendors.

Utilizing site enablement technology, processes and platforms that seamlessly integrate with sites’ workflows can bring about substantial advantages for the broader trial ecosystem. Such technology alignment reduces the need for redundant data input, thereby reducing the risk of errors and duplicative effort by site staff. Additionally, it brings about insights from data more quickly by eliminating the need to enter results into multiple systems, often well after patient visits.

Establish Universal Processes

While it is important to recognize the value of platforms spanning the entirety of a trial, there remains room for enhancing the overall workflow. Currently, workflows and systems are often compartmentalized and centered around specific trial aspects or processes. This raises the question of whether we are potentially overlooking opportunities to leverage data and solutions from one phase of the trial to inform and enhance downstream processes.

Although the idea of a handful of all-encompassing solutions overseen by a select few vendors may seem ideal, it’s not a practical reality. Such an approach would clash with the diverse and intricate requirements of various trials. Currently, platforms are emerging for establishing vertical connections that link sites, sponsors, CROs, and vendors. However, as the clinical research enterprise moves toward the goal of system interoperability, we’re witnessing a shift toward platform solutions that foster horizontal connections. These solutions are adaptable across a broader range of trials and are seamlessly integrated into site workflows.

Sponsors, as the financial backers of trials, wield the necessary influence to implement these changes. By viewing the trial workflow as an interconnected ecosystem rather than isolated components, we can quickly identify areas for improvement that need a champion to lead the charge. The essential components are already there—they simply need to be put together.

Become the Sponsor of Choice

In an increasingly complex and competitive clinical trial landscape, it is crucial that sponsors rethink the role of sites. By involving site representatives early in the trial design process, sponsors can tap into their wealth of experience and insights, ensuring that protocols are not only patient-centric but also operationally feasible.

Prioritizing site-centric technologies is another crucial aspect, as it empowers sites to manage multiple trials efficiently, reducing redundancies and the risk of errors. The synergy between sponsor-selected technology and site workflows paves the way for a smoother, more integrated trial ecosystem. Moreover, by embracing universal processes that foster interconnectedness across all stages of a trial, sponsors can lead the charge in driving comprehensive and impactful change.

As the driving force behind clinical trials, sponsors have the unique opportunity to reshape the industry by aligning incentives, fostering collaboration, and placing sites at the heart of trial innovation. Through these strategic initiatives, sponsors can emerge as innovators in clinical trial execution, setting a new standard of excellence in a competitive and evolving landscape.

Matt Smith is Vice President of Site Development for Slope. He has a proven track record of contributing to company growth and expansion, with 20 years of leadership and development experience in the clinical research, software as a service, and communications industries, including through roles with IBM Watson Health, Devana Solutions, Forte, and ICON’s global site network. At Slope, he focuses on helping sites transition to the company’s free inventory and sample management platform.