How should we define success when it comes to clinical trials? There are many things we want to go well, but ultimately, the reason for running a clinical trial is to collect quality data that can support the commercialization of new treatments for patients. So, no trial is a “success” that doesn’t achieve this goal.
Today, most industry professionals would agree that a clinical data management system (CDMS) is essential for every clinical trial that aims to collect and analyze data properly—and produce acceptable results with as much ease, efficiency, and reliability as possible. There are some who think that means data collection should be completely digital. Today, in 2021, we must disagree. There are just too many scenarios where it won’t work—or where it’s not worth the struggle to make it work. And that’s fine. There are many other options.
There is a range of solutions on the continuum between trials that are completely paper based and trials that are completely digital. That’s a good thing, since you may need to deal with a range of scenarios, especially if multiple sites are involved. The fact is that your trial is most likely to go well and least likely to drive you crazy unnecessarily if you accept the fact that some sort of hybrid solution is the best choice.
What is a “hybrid” trial?
“Hybrid” means sites can submit CRFs both on paper forms and electronically. The database will have the ability to accept data both ways. This approach lets “the data tell the story” and does not force a specific technology on that data. In effect, the hybrid approach is the data-centric approach. If it makes sense to collect data on paper, or it’s already on paper, then leave it there.
Ensuring success with hybrid trials.
To make sure your hybrid trial has the best chance of success, keep these pointers in mind:
- Fully assess and clearly indicate upfront to all stakeholders what data will be handled with paper and what will be handled digitally.
- Make sure sites have a clear understanding of all relevant procedures and receive proper training.
- Always make certain there is solid collaboration across all concerned functions, including Medical, Clinical, Statistics, Data Management, and IT.
- You’ll need good internet service and a reliable scanner in every instance where you want to submit data digitally
- Have a complete paper packet with current CRFs on hand
- Secure accurate data validators
The fact is, it’s relatively easy to succeed with a hybrid CDMS. After all, it’s the approach that makes allowances for any circumstances you’re likely to face.
What’s your approach to clinical trial success?
Is your data strategy solid? Can your CDMS handle whatever challenges your trial might encounter in the weeks and months ahead? At DFnet, we have more than 20 years of experience in providing research teams with the security and peace of mind they need to proceed with confidence anywhere in the world. Let us know how we can help you.