Checklist to Reduce Burden on Sites and Patients

The site-sponsor relationship continues to become more important day by day. With trial complexity increasing, site staff availability stretched thin, bespoke methods of interaction, and unique methods of engaging with patients administered by sites, the relationship is complicated.

While considering how to engage the global and very unique set of partners, we often silo down to the term “sites.” However, each site is different, and sponsors and contract research organization (CRO) study teams must continually evaluate how they engage uniquely with each site and find ways to make collaboration and workflows more efficient. This is the root of reducing site burden – without adequate communication and understanding of site needs, sites will face unnecessary burden.

Examples of Where Burden Will Likely Occur, and How to Combat Them

Attempting to eliminate complexity and frustration throughout the entire trial can be an impossible task. However, focused small attempts to reduce redundancy and ease processes can have a big impact on the operational and regulatory success of your study.

Is Your Trial Designed to Leverage Site-provided Information?

Site Feasibility Questionnaires (SFQs)

To save time on their end, sponsor study team members often distribute generic SFQs to sites they may have already engaged or received responses from. This can create significant redundancies for sites. In a recent survey of 500 sites in North America, only 25% report sponsors and CROs met the goal of focusing feasibility on protocol-specific questions only and leveraging former responses to non-study specific questions.

Budget Negotiation and Contracting

The time investment in the legal process of contracting and very real limits of budgets will always be a factor. However, when writing out a budget, don’t start at ground zero. Take the time upfront to include previous clauses or rate cards the site has agreed to previously. If this is the first time working with a site, identify the country or state clauses to include in your country contract template and drive it as close to site specific as possible before sending. Additionally, find terms to apply across multiple programs. Similarly to feasibility questionnaires, this upfront investment will pull forward previous contractual and budget knowledge into your new trial, making the budgeting and contracting process go faster.

Is Your Trial Designed to Leverage Technology and Training Already in Place at Sites?

Document Exchange

If a site has an electronic investigator site file (eISF) or another document management system, consider interfacing rather than requiring an entirely new system. There are a myriad of hurdles sites face managing multiple systems, but one in particular is maintaining shadow systems, obfuscating a shared understanding of the source of truth. If one document is stored in multiple places due to a site aligning with their own SOPs or a sponsor’s desire to exchange documents via a second investigator site file technology, it can be nearly impossible to easily point to (or remember) which document is correct when a monitor or inspector arrives.

This has drastic implications, potentially leading to trial misinformation, using previously versioned documents, and providing risk to the trial and patient.

Training

Accepting training from your organization from one study to the next on general research requirements can go a long way. It’s not productive to force the same non-study specific training (for example, good clinical practice [GCP] training) on a site if they’ve already completed training through a different trial within your organization. Instead, verify the source of their training to ensure it meets reputable and regulatory standards.

Logins, Access, and Security

In a recent survey, sites reported using an average of four to six sponsor-provided technology logins per trial. When sites are supporting even just five studies, administrative headaches and security risks add up. In the same survey, 80% of sites rated using the site’s own credentials to access sponsor technology was rated at extremely or very valuable.

Longboat, Advarra’s intuitive workflow technology for study teams, sites, and patients allows sites to use their own credentials to access the system. Longboat reduces the number of logins and stand-alone sponsor-provided systems for sites by over 60%.

Do Your Trial Operations Include Resources Sites Need for Success?

The investigators, nurses, and clinical research coordinators (CRCs) supporting a study likely have tight schedules with very little room for things to slip. This is especially true once they are engaging with patients – they don’t have extra time to focus on administrative tasks.

Visit Guidance and Protocol Text Search

Through these tools, sites can get up to speed on procedures and protocols quickly. Staff can also refresh their memory on what they have to do, who’s coming, and when, all while providing the relevant information to the patient to keep them informed as well.

Amendments

With protocol amendments, staff will need to update and re-sign documents. Additionally, they will need to modify training to reflect amendment changes. If there’s a significant amendment coming out, think about how sponsors can minimize the amount of touchpoints with their site while ensuring everything is compliant and on track. This could take the form of identifying a change log for each document to ensure the staff know the severity of the change. Sites could also implement training that can be incrementally changed and reviewed independently. This reduces the redundancy of all non-changed training while still maintaining the connection to the trial scope as a whole.

Audit Readiness

Before a study closes out, the Food and Drug Administration (FDA) may request an inspection. Sponsors must make sure the site is supported in documentation throughout the study. That way, if the FDA calls for an audit, everything is where it needs to be.

Centralizing, Connecting, and Simplifying the Process for Stakeholders

To enhance site efficiency, sponsors should focus on centralization, connecting stakeholder systems, and simplifying tasks. Centralizing study information streamlines processes, while integrating information flow ensures efficiency and seamless communication. Simplifying tasks by condensing requests and providing upfront resources alleviates organizational workloads, maintaining a smooth study process.

Addressing these areas of burden may vary across each unique type of site. However, it’s necessary to have these conversations with sites to minimize unnecessary burden and improve the clinical trial experience for all.

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