Summary:

Some clinical trial startup challenges are easy to see coming. Others can lurk in overlooked operational details involving supplies, equipment, study materials, translations, and global logistics. This article explores those risks and offers practical ways to prepare before they affect study timelines.

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Don’t Let Startup Delays Haunt Your Clinical Trial

Being a sponsor of a global clinical trial is not for the weak-hearted. And since it’s Halloween, let’s cue the scary music! What can make a sponsor’s hair stand on end? Study startup delays are certainly high on the list. Delayed study startup can curse your entire clinical trial by:

• Delaying site initiation visit (SIV) and first-patient-in (FPI)
• Missing enrollment timelines, including last patient first visit (LPFV) and other targets
• Losing ground with compliance and attrition issues, including last patient last visit (LPLV)
• Struggling with the complexities of global clinical trials
• Checking out that strange sound you heard in the basement when you should just leave

Study startup challenges are sinister, and they grow and grow! Don’t panic, your trial isn’t doomed. Just be very careful, keep your eyes open, and plan, plan, plan. Don’t wait for the zombies to arrive before you start planning. Here are some helpful tips.

Beware of the unexpected!

There are well-known causes of delay in the execution of a study. The following are usually expected and rarely come as a surprise:

• Site contracting
• IRB/EC approvals
• Protocol amendments
• Patient enrollment
• Patient retention

But what about the clinical trial startup challenges that are lurking in the shadows? Trials haunted by hidden causes of delay may lack planning around these vital activities:

• Ancillary supplies and equipment (getting the right supplies and getting them to sites on time)
• Study materials and approvals (recruitment materials, dosing diaries, etc.)
• Translations (materials translated accurately into local languages)
• Recruitment planning
• Global logistics

These components hide well (and they’re good at suppressing their sinister giggling) because they aren’t always part of a sponsor’s planning process. Yet they can cause major problems when left out. Identifying each of these elements and addressing them early in the planning process can help support on-time trial execution.

Common gaps prior to study startup

Activities leading up to study kickoff and site initiation may fall short when these three areas aren’t fully considered:

• Protocol requirements
• Site needs and wants
• Local considerations

Let’s explore examples of each of these gaps in high-definition detail:

Protocol requirements

The specific requirements in a protocol can create special challenges, especially in multinational trials. For example, a protocol may require certain brands of equipment to support consistency across study sites and data collection.

Different types of equipment are regulated in certain countries. In our experience, sponsors don’t always fully consider where equipment or supplies will be used. Trying to ship a given brand of equipment into a country where it is not approved is a recipe for disaster.

Electronic devices require a power cord (pro tip: don’t trip on these when trying to escape the monster). The power setup needs to be compatible with the sockets and voltages used in each country. Anyone who has traveled internationally has experienced this firsthand.

If alternate items have not undergone compatibility testing, sponsors may find themselves in a bind when the preferred equipment is unavailable or delayed.

Equipment availability can present procurement challenges, but the impact can extend beyond sourcing. Having compatibility testing done in advance on alternate items gives you flexibility if the preferred items aren’t available or will be significantly delayed. Unexpected disruptions can make it difficult to source the supplies needed to run a trial, particularly when studies span multiple countries.

Another protocol requirement that can create study startup challenges is the need to keep the study drug within a specific temperature range. This affects how the drug is stored, packaged, and transported, and it is a complex undertaking.

 Site needs and wants

This is where a lot of boxes need to be checked off. What do sites need and want to get started and conduct the study successfully? What will they need to comply with protocol requirements? Don’t leave your sites alone in the wilderness.

Do your sites have all the equipment that’s necessary to conduct the trial? They might have outdated equipment, or it might not be calibrated appropriately. Are all sites able to capture information consistently and accurately from the tests that will be conducted?

Different sites often want different materials to conduct the study. Some may want, for example, a pocket protocol they can carry with them, a laminated guide outlining the site process, or specific recruitment materials. These individual preferences need to be identified and shipped to the sites. Sites are not one-size-fits-all. More on this in the next section.

Local considerations to prevent on-time study startup challenges

Multinational studies can involve significant local complexity. Differences in requirements from country to country can affect study startup and require planning at the local level. This can include maintenance, calibration, disposition, customs clearance, import regulations, technology infrastructure, regulated devices, instructions for use, and translations.

Here is a common issue: Once a software platform is selected, confirm that all sites have the equipment and bandwidth needed to use it effectively.

Again, the logistics challenge rears its head. Specific brands are just part of the issue. The way you label and package those items can have a direct impact on whether they will be allowed through customs. Navigating regulatory requirements, distribution channels, and customs so items reach study sites on time presents another set of challenges that must be considered.

When these issues are not properly planned and accounted for, the bottleneck of global logistics can lead to significant headaches and unexpected delays.

Translation is another issue critical to study conduct. It can impact recruitment, consent, and retention. It goes beyond just getting the words translated and onto the page. Effective translation involves considerable nuance, including local dialects, cultural considerations, and more.

Too often, teams think of translation too late and then discover that turnaround times are much longer than expected. Imagine reporting to management, investors, and your customer that the study start is on hold because you are waiting for translations. The devil is in the details when it comes to creating delays.

Considering the impact on study timelines

Here are typical timelines for different elements of study conduct.

Some startup activities can proceed at the same time, while others depend on earlier steps being completed. When a critical dependency is delayed, it can maniacally affect the activities that follow. For example, materials have to be written and approved before they can be translated and produced.

Individually and cumulatively, these gaps in planning disrupt study timelines and add ghastly costs. Ignoring them, or setting them aside to sort out later, is an invitation to failure.

To sum it all up: Don’t be a study startup victim. Don’t be like a group of teens facing danger! Make good choices!

Clinical Trial Startup Readiness Checklist

Before study startup, consider the following:

Protocol and equipment

☐ Identify protocol-required supplies, equipment, and kit components.

☐ Confirm specifications, availability, and lead times.

☐ Identify acceptable alternatives and any approvals needed before substitutions can be made.

Site readiness

☐ Confirm site equipment, calibration, training, and storage requirements.

☐ Identify site-specific materials and expected quantities.

☐ Plan for replacement supplies and resupply throughout the study.

Materials and translations

☐ Account for writing, review, approval, translation, and production timelines.

☐ Identify local language and cultural requirements.

☐ Plan for version control and updates if the protocol or study materials change.

Global logistics

☐ Confirm country-specific product and import requirements.

☐ Identify vendor dependencies and establish a process for tracking at-risk shipments.

☐ Build sufficient time into the schedule for shipping, documentation, and customs clearance.

☐ Establish clear ownership and escalation pathways for items that could affect site readiness.

And one last thing:

☐ Have a backup plan in case the zombies arrive.

The Imperial Advantage

Planning an upcoming study? Don’t venture into the study startup woods alone! Sink your fangs into study startup success by calling on Imperial.

Though we are mere mortals, Imperial helps sponsors and CROs manage ancillary supplies and custom kitting, study materials, translations, and global logistics. Coordinating these needs early can help reduce handoff delays and prevent last-minute surprises during study startup.

Talk with Imperial about your upcoming study and the support you need for a successful startup.