Why Sponsors Should Share KPI Rationale With Sites

By Amy Bland, CEO, Curo Research

When clinical research sites are trying to juggle the day-to-day aspects of running a practice with the additional facets of clinical research, the nitty-gritty details can feel overwhelming. Included in those at-times overwhelming demands are sponsor-enacted KPIs. Depending on the nature of the clinical research, KPIs can include the number of potential candidates contacted, the number of new participants, participants at each stage of the process, adverse reactions, and various outcome metrics. However, sites don’t always understand why they need to collect and report this data, making the ask feel like another thing on their to-do list. In turn, this can contribute to sites feeling disconnected from their sponsors.

To close this gap and build partnerships, foster transparency, and promote shared accountability, sponsors must clearly communicate with sites why specific information is essential. To take the stigma out of KPI data, sites need to understand how it is used beyond their own site.

The Operational Reality At The Site Level

Clinical sites often integrate research into their existing workflows and are supported by a small team. Sometimes, one coordinator is doing everything from clinical responsibilities to regulatory requirements to patient coordination, simultaneously. Without proper information from the sponsor, tracking and meeting KPIs can feel overwhelming to site staff, and the value is not immediately visible. Sponsors have to help sites understand that the KPIs are strategic inputs, not just administrative tasks.

KPIs Commonly Collected By Sponsors

KPIs vary depending on the nature of the study, but they commonly include metrics such as:

• number of participants identified or contacted
• screening, enrollment, and retention percentages
• participant statuses
• adverse events and safety reporting
• protocol deviations and visit completion
• study-specific outcome measures,

Sponsors review this information across all sites to gain a real-time understanding of study feasibility, participant safety, and operational performance. Yet, these outcomes are not often clear to sites.

Sites Don't See How KPIs Help Behind The Scenes

One of the most critical reasons sponsors should explain KPI requirements is that sites are often unaware of how widely this information is shared and how many downstream decisions depend on it.

Sites need to know that information is reported to senior leadership and boards of directors. A sponsor's board of directors is usually not medically trained. They are business professionals. For them to fully understand the clinical study, how it is progressing, and what that progress means for their organization, they need precise, demonstrable data. Recruitment rates, retention trends, and safety signals inform high-level discussions that shape a project's future.

KPIs can help sponsors:

• plan budgets for the upcoming fiscal years
• determine whether additional recruitment resources are needed
• consider protocol amendments when consistent challenges appear across multiple sites
• adjust staffing plans for on-site monitoring or clinical support
• set or revise timelines for data locks, interim analyses, and key milestones.

Without insight into this process, sites may not realize that delayed or incomplete reporting can affect decisions far beyond their individual location.

Regulatory And Ethical Oversight Depends On Site Reporting

Independent oversight bodies play a critical role in protecting research participants, and their work depends on accurate data flowing from sites through sponsors.

An unassociated IRB reviews studies for ethical and legal compliance with the main purpose of protecting the safety and rights of patients. In addition to the initial approval of a study, the IRB provides continuous oversight to make sure researchers follow GCP guidelines and federal regulations, preserving the welfare of participants. A separate body, the Data Safety and Monitoring Board (DSMB), reviews data collected intermittently throughout the trial or study, looking at safety, progress, and effectiveness of the intervention. The DSMB recommends whether the study should be continued as is, modified, or terminated and provides reports to the sponsor.

KPIs Enable Support, Not Surveillance

Equally, or perhaps even more important, are the benefits to the site itself. For example, have they been making copious calls to potential study candidates over weeks or months but still haven’t managed to sign anyone up? The sponsors and boards can see the effort and provide guidance or ideas to improve results. They may also be able to pair the struggling site with sites that have had similar problems. Multisite clinical research allows one site to benefit from the knowledge and experience of another. There may be different approaches that can improve participation across all sites.

In some cases, all sites might be having the same problem. Sponsors might adjust the protocol if they detect such study-wide issues. Without site input, those providing oversight may not understand the issues at the grassroots level.

Protecting Sites And Patient Access

Are sites aware that consistent KPI reporting also protects them? When sponsors cannot demonstrate engagement and compliance with oversight bodies, there is a risk to the site’s continued participation. If a location is not providing KPIs as expected, it can jeopardize its future with the trial as well as the future care of patients who may benefit from the procedure, device, or medication being studied.

Supporting Efficient Site Operations

KPIs also offer practical benefits at the site level.

For example: Is a potential or current study patient coming in for a visit? Who needs to see them? Does the clinical coordinator, attending provider, patient educator, or other specific staff need to be there? Is additional time needed for this visit or procedure to make sure that all study-related requirements are covered?

Being prepared can lessen the impact that participation in the clinical study has on other practice activities and personnel. It also shows the participant that the site is efficient and understands both their needs and those of the process itself. Collecting the required data in a timely manner helps site staff avoid the anxious rush to get it all together at the last minute.

A Call To Action: Transparency As A Tool For Collaboration

Sponsors should set the tone for the sponsor–site relationship, and clear communicating the value of KPIs is an opportunity to strengthen that collaboration. Asking sites for information without explaining its purpose creates distance. Taking the time to explain why specific data is needed builds trust, alignment, and shared ownership of study success.

Sponsors should actively engage with their sites to discuss KPI expectations and help them understand how the information they provide supports decisions on budgets, protocol considerations, staffing strategies, data lock timelines, and other key milestones. When sites understand how their data is used beyond their individual location, reporting becomes a meaningful contribution rather than an administrative burden.

Communicating this rationale clearly is a commitment to transparency, one of the most effective ways to demonstrate partnership. It helps dismantle the us versus them dynamic that can develop when communication feels one-sided or opaque. When sponsors communicate expectations clearly and explain the reasoning behind data requests, KPIs actually become helpful tools rather than something to stress over. This approach gives sites confidence to do what they do best, which is focus on patient care and contribute to meaningful research.

About The Author:

Amy Bland is the chief operating officer of Curo Research, where she is committed to promoting quality data collection, ethical patient treatment, and mutually beneficial relationships in clinical research. With 13 years of experience — half spent launching research-naive sites — Amy has developed a well-rounded expertise in starting and growing research programs from the ground up. Her hands-on experience at the site level has given her unique insights into the challenges and opportunities faced by new research sites. As a certified clinical research coordinator, Amy has achieved top enrollment rankings while maintaining over 90% data accuracy and follow-up compliance. Her mission is to make clinical research accessible to any site motivated to learn, fostering an environment where research becomes a widespread and viable option for sites and patients alike.