Considerations for Complex Longitudinal International Studies
DatStat has had the good fortune of supporting health researchers with our technology for close to 2 decades. These researchers conduct novel and massively complex international clinical trials and studies with ambitious goals across the globe. Their work in infectious and chronic disease and other areas have resulted in major breakthroughs and advancements in medicine that have helped 10,000s of people.
As one might imagine with anything that bold and broad, there are A LOT of moving parts, many of which are so interconnected that when one thing goes wrong there is danger of it cascading into other areas of the research. Many times these interconnected (and rapidly moving/sometimes infrequently “oiled”) parts don’t seem very connected. Below are a few things to consider before embarking on a longitudinal international study.
Examples of Known Unknowns
To Authenticate or Not?
Why does it matter when designing a trial or study if there is a participant list pre-populated into the offline data collection software? Can’t we just pre-load the forms and then pull up the one that matters without pre-loading or authenticating the participant?
Absolutely yes, you can do that easily. If you have one person or device that’s responsible for collecting data on that 1 sample or participant it might not be necessary to authenticate. Many principal investigators (PI’s) and their lead project managers (PMs) design the study without having taken the research into the field and been “on the ground”. The problem generally arises when you can’t reach that subject at the first attempt and you want to be able to send someone else to go capture that data or follow up data and they are using a different device. In that scenario, authenticating the survey or eCRF makes your job as project manager much easier and efficient.
Mitigating Data Loss
On the flip side of that, when doing large-scale international studies there are dangers of pre-loading participant lists when those lists can include 1,000s of participants. The danger being, when you go to synch that data back to the server after collecting it offline, you may be trying to synch too much data that is extraneous or duplicative. We’ve had more than one researcher come to us after a year or two working with another vendor in the field capturing data, because they have experienced lost data through the synching process. That can be devastating. At the outset of the study when enrollment is reserved to a small sample or pilot, the synch worked flawlessly, but once the next phase or wave of data collection hit, the synching became a nightmare. This is testimony to the importance of testing the synchronization process to ensure your hard-earned data is uploaded and stored properly.
Coming Up – Lessons Learned…
This is all to say that we feel your pain as both a PI and as a PM, because people on our team have been and act as both. In this series about considerations for optimizing data collection for large scale international research, I will provide real-life examples of how others in similar shoes addressed challenging issues. On the next installment, you will learn about a Sub-Saharan Africa clinical trial working to eradicate HIV in remote populations. Later on, I will detail the most ambitious “census” ever attempted to combat chronic disease in Saudi Arabia.