What Causes Delays in Vaccine Trials?

Vaccine trials are critical to public health, but they are also complex and highly scrutinized. When delays occur, they can have far-reaching consequences, from prolonged time-to-market to increased costs.

If your vaccine trial has gone “off the rails” so to speak, it’s crucial to address root causes quickly and accurately. 

Here, we outline five common causes of vaccine trial setbacks and provide guidance on how to get your study back on track.

5 Common Causes of Vaccine Trial Delays

1. Poorly Written Protocol

Vaccine trials often require complex protocols. A poorly written protocol can create confusion, leaving important elements open to interpretation. When study teams and sites interpret the same protocol differently, inconsistencies in data collection and trial conduct can occur, resulting in potential delays and loss of valuable data​​.

2. Inadequate Training

Vaccine trials have unique requirements, from handling investigational products to adhering to specific regulatory guidelines. Inadequate training of study teams can result in mismanagement, including errors in data entry, improper dosing, or failure to adhere to safety standards. A well-trained team is essential to making sure any study runs smoothly and data integrity is maintained​.

3. Inadequate Documentation

In vaccine trials, especially those involving multiple doses or long-term follow-up, documentation is critical. The FDA mantra “If it’s not documented, it’s not done,” rings especially true. Incomplete or inconsistent records can lead to FDA audit findings that are difficult to resolve years after the trial has concluded. Proper documentation allows for traceability and accountability throughout and after the study​.

4. Lack of Resources

Vaccine trials are resource-intensive, often requiring specialized facilities, equipment, and personnel. A lack of financial or human resources can delay patient recruitment, follow-up visits, and data processing. Additionally, without adequate resources, research sites may struggle to complete critical tasks like data entry, product accountability, or adverse event reporting, causing regulatory issues​​.

5. High Turnover

High turnover rates in vaccine trials can lead to inconsistent trial conduct, loss of institutional knowledge, and delays in decision-making. Whether at the sponsor, site, or CRO level, frequent personnel changes interrupt trial continuity, leading to delays and potential compliance issues​.

5 Steps to Getting a Vaccine Trial on Track

1. Mental Preparedness: Focus on the Long Game

Vaccine trial clean-up isn’t a quick fix. Challenges faced during study recovery provide valuable learning experiences, helping you and your team better prepare for future trials. Embrace the situation with a positive mindset, accepting that while things may not have gone as planned, they can be corrected with the right approach.

Acknowledging the current state of your trial and identifying root causes is the first step. Whether it's due to data inconsistencies or recruitment shortfalls, the clean-up process requires collaboration and commitment from the entire study team. 

At Remington-Davis (RDI), our experienced staff can help guide you through this critical phase, providing the leadership needed to keep the team focused and motivated​​.

2. Garner Support: Leverage Expert Resources

You can’t do it alone. Vaccine trials require significant resources—personnel, time, and budget—to get back on track. This is where the expertise of an independent site like Remington-Davis shines. 

We work closely with sponsors and CROs to assess the extra support needed, whether it’s tapping into our diverse patient pool or adjusting recruitment strategies to meet trial targets. While keeping you within budget, we secure the resources you need to get your trial back up and running.

3. Establish a Prioritized Approach: Tackle One Issue at a Time

The next step is to conduct a thorough internal audit to identify all the gaps in your vaccine trial. Using tools like the FDA’s BIMO checklist, we can assess where the study is falling short—whether in areas like site training, data entry, or regulatory documentation. Once the issues are identified, you can develop a clear, prioritized plan to address them methodically.

At RDI, we specialize in helping sponsors and CROs regain control of their vaccine trials by focusing on one issue at a time. We’ll collaborate with you to create an actionable plan that outlines clear steps to resolve each problem, making the clean-up process smooth and efficient.

4. Clear Communication: Keep the Team Aligned

During a vaccine trial recovery, communication is all the more vital. Separate the day-to-day tasks of managing the study from the clean-up effort. Scheduling dedicated calls and meetings focused on clean-up progress keeps everyone aligned on goals and expectations.

Remington-Davis takes a proactive approach to communication. We maintain open lines with stakeholders so everyone stays informed about protocol amendments, monitoring reports, and other key updates.

5. Set Realistic Timeline Expectations: Plan for the Unexpected

Once you have a recovery plan in place, set realistic expectations for how long the clean-up will take. Studies that have gone off track tend to take longer to recover than expected, so it’s important to build in extra time to account for any unforeseen challenges.

Remington-Davis has a proven track record of helping sponsors and CROs meet their trial timelines—even under tight deadlines. With our hands-on approach and emphasis on service, we can adapt and respond to the evolving challenges of vaccine trials quickly and effectively.

If your vaccine trial needs help, contact Remington-Davis today. We’ll share how we can support your study clean-up efforts and deliver results that meet regulatory requirements and your project timelines.