Direct Data Capture and Its Future in Clinical Trials

Learn more about Direct Data Capture and what its future holds in clinical trials.

The Future of DDC in data collection for clinical trials
As technology advances, it’s meant to improve our lives simultaneously. With that said, Direct Data Capture, DDC for short, is currently improving at a rapid rate in clinical trials – which only means good things for patients and medical practices alike. And what’s more, both patients and clinicians will have peace of mind as Clinical Ink leads the charge in decentralized clinical trial conduct. We know that data collection and following the correct procedures in data collection is crucial the world over, especially when it comes to medical information. But what if data collection can be made easier? Let’s dive into the future of direct data capture in data collection for clinical trials.

What is direct data capture?
Direct Data Capture forms part of the four types of eSource. What is eSource? In simple terms, eSource means that electronic data is source data. It is essentially a way of collecting data by directly putting this data into an electronic record. Sounds confusing? Think of it as filling out a digital form. Right, back to DDC. With DDC, it is the process of inputting data into an eCRF (a paper or digital questionnaire) contemporaneously. Essentially, you are filling in a form digitally instead of on paper. The patient\’s data is captured immediately into a DDC tool during a visit.

What is data collection?
According to the United States National Library of Medicine – National Institutes of Health, data collection for clinical research is the act of gathering variables relevant to research. Further, these variables include patient parameters, data items, data elements, or questions, which are aggregated into data collection forms for study implementation.

What are clinical trials?
When medical teams want to evaluate a medical, surgical, or behavioural intervention, they perform clinical trials on people, also referred to as research studies or cases. Clinical trials are the primary tool to determine if a new treatment or surgery (think a new prescription drug, a life-saving medical device like a dialysis machine, or a ground breaking spinal surgery that takes one hour) is safe AND effective in people. In many cases, clinical trials are also used to determine whether a new treatment will have no, fewer, or more side effects than the current treatment. But that’s not all clinical trials are used for. In other cases, it’s used as a tool to detect diseases early to prevent health problems. Another way clinical trials are used is to ease suffering for people living with deadly diseases or chronic health problems like asthma.

The Future of DDC
There have been many positive views on the future of direct data capture, such as improved patient experience, fewer errors, and saving time. Yet the paper solution consistently wins this race. But will DDC win the marathon? The simple answer is yes. Will it be tough to convince clinicians to switch over to DDC? Absolutely. Dan Vahdat, CEO and founder of Huma, noted that the digitalization of clinical trials enables researchers to “collect a lot more data, a lot more easily and from a lot more people.” Now, this is the future, and it cannot be denied. What organizations should consider is that eventually digitizing processes will catch up with them, and offering an easy-to-use system will benefit everyone – the point is to look toward the future, and however scary it is, it includes digitization. Something to consider for the future is to also look at a hybrid approach. The future can also work this way. Part of this could be that DDC is used as the main way to capture data, and the paper-based solution is used as a backup in case of power failures or systems being down – these issues can arise. Another benefit of a hybrid approach is that if the clinical trial includes multiple sites, you should be using a system that works specifically for each site, whether digital or paper.

But we also must look at this from a patient perspective. DDC allows patients to capture data directly into an electronic tool, meaning patients can participate in a clinical trial from anywhere AND track any side-effects and success digitally. And from a monitoring perspective, it allows organizations to review data in real-time.