Author: Muhammed Bilal, Vice President of Data Sciences at Medrio
Within the clinical trials industry, even minor delays can cause major frustration and disruption, ultimately postponing research reporting or implementation of findings, missing a go-to-market window, or preventing life-changing solutions from reaching the people who need them at the earliest possible moment.
So why do delays occur, and what problems can they cause? In my 18 years of clinical data management experience, I’ve seen that delays are predominantly caused by human error and are exacerbated by ineffective communication and a lack of proper task planning and distribution.
For example, a sponsor could be all set to have a strong start for their clinical trial and have selected the right sites for their protocol. Yet, if the clinical database is not ready on time, a domino effect is created, potentially jeopardizing the entire trial.
Once an initial delay occurs, key processes also can fall behind. For example, if the database is not set up in time for the first subject visit, data entry cannot be started on time. The data entry then may fall behind and, later, could result in compromised data.
Essentially, the initial delay can mean that the timeline for the next steps in the project gets squeezed, which puts the project at greater risk for additional mistakes and negative feedback from sites, clients, and colleagues.
Here are five steps to take to reduce the risk of database delays.
1. Templates, templates, templates
Creating ready-to-use templates, such as eCRF templates (library), data management documentation templates, and SAS programs, is the most efficient way to reduce delays and the risk of human errors.
Any templates created must be approved by all stakeholders and built to be easily editable so that they can be updated with the study design specifics as per protocol. Documentation design time and risk of error can be greatly reduced when approved templates are accessible in the EDC system and a user-friendly data entry guide is in place. Area-specific templates also can be created to form a framework for individual fields of study. This can reduce adaptation time in comparison to more general templates.
Don’t forget to schedule regular reviews of your template libraries to ensure they are up-to-date with applicable industry changes.
The benefits of templates should not be underestimated. While creating them can be time-consuming upfront, their long-term benefits are immense.
2. Realistic timelines and cross-team transparent tracking
The next step to reduce the risk of delays is to build a schedule of realistic study timelines as early as possible.
Once the schedule and protocol are defined, it is vital to ensure that all team members are trained and understand both the deadlines that apply to their areas and the downstream consequences of missed milestones. Start as early as possible in socializing the project details. A final draft protocol should be used if the final protocol is not in place when the project begins.
Encourage intra- and inter-team communication by paying attention to each person’s involvement and ensuring a full understanding of how their roles relate. Transparent tracking of project milestones and continued communication help the team share accountability. Should a delay or a risk of a delay be detected, the team can work quickly and collaboratively to adjust the plans and begin establishing contingency plans.
3. Testing and continuous learning
Clinical Trial Databases must pass User Acceptance Testing (UAT) before going live and production can start. When properly conducted, User Acceptance Testing (UAT) can limit the need for re-testing later.
Build schedules to allow adequate time for User Acceptance Testing (UAT) before going live. When possible, a Full Database UAT is advised, which includes checking all eCRF pages and online edits. However, if time pressure is too great, a Risk-Based UAT approach can be used that tests only new, untested, study-specific eCRF pages.
After each project has been completed, it is essential to document key lessons learned, as this provides a blueprint to ensure the success of future projects and continuous improvement of data management processes and documentation.
4. Build an experienced team
Resource your project with team members who have experience working in the area of study, and build time into the project set-up to ensure that each team member clearly understands the protocol, technology stack, project complexity, deadlines, and demands.
5. And finally… Choose the “right” EDC system for your needs
With so many EDC options, it’s vital to select the EDC system that suits the types of trials your company is running, specifically, and the types of sites you will engage with.
Questions to consider as you evaluate each of the various EDC providers:
- How many EDC implementations has this provider completed?
- Does this EDC provider have case studies from organizations like mine or studies like this one?
- What level of programming resources are required to implement this system? Do I have those resources in-house? In a resource-constrained organization, selecting an EDC that does not require custom coding can save time and minimize the need for professional services.
- Does the EDC system facilitate compliance with ICH GCP, FDA 21 CFR Part 11, GDPR, and other standards, right out of the box? To avoid any unforeseen regulatory challenges, it is vital to choose an EDC system that supports the specific compliance needs of your clinical trial.
- What validation environments and data quality controls are included with the EDC? Choosing an EDC that meets the strictest of global data collection regulations and is purpose-built to ensure your study data’s integrity, security, and quality can reduce downstream risks.
- What real-time reporting capabilities does the EDC offer? The ability to “track and react” to live study data makes regulatory submissions easier.
- Does this system support the seamless collection of eCOA, ePRO, ObsRO, and ClinRO?
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Recognizing that any single mistake can create a domino effect of problems down the line, take time to make sure each team member is well-trained and well-practiced on the EDC system that is in place.
Getting your study to database lock efficiently and effectively is no easy feat. With Medrio EDC, you can achieve process efficiencies and improvements that lower costs, shorten timelines, and decrease resource utilization.
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