Patient Data Collection 101: Curebase FLASH Webinar Overview

There are a variety of ways in which patient data can be collected in clinical research. As such, it’s critical to keep patients informed on these methods as they progress through trials. In Episode One of Voices from Within: Humanizing Clinical Research Data, Curebase experts share a comprehensive overview of how patient data is collected and the safeguards in place. This 15-minute Flash Webinar was led by Vice President of Clinical Trial Innovation, Jane Myles, and Director of Data Management, Kim Andreasen.


“There are many existing myths and stories regarding data collection in clinical trials,” Jane notes. On a foundational level, there are two types of clinical trials: brick-and-mortar and decentralized clinical trials (DCTs). The traditional brick-and-mortar trial refers to in-person visits that take place in centralized hospitals and doctors’ offices with care teams. With technological advances, DCTs have become available to patients, making healthcare more accessible to a wider more diverse population. This format allows participants to participate in clinical trials from remote settings through technology-enabled services including telehealth appointments, at-home testing, mobile phlebotomists, and more. Some DCTs even utilize patients’ own local doctors to perform wellness checkups, biopsies, and other care procedures that require an in-person aspect. 


“Ultimately, the purpose of clinical trials continues to be the collection of clinical data to make decisions about the safety and efficacy of new treatments,” Jane explains. For research teams, data collection is the primary deliverable of clinical trials. A recent study by Tufts University concluded that the amount of data collected each year in clinical trials is increasing exponentially, likely caused by new technology, new research fields, and other variables.

Understanding the importance of data collection in clinical trials is critical. Understanding as a patient how your data is being collected, used, and protected is even more important. Kim, an expert in data management, breaks down the process of data collection. To begin, participants share information with their clinical trial care team or provide this data themselves through survey responses about their experiences, symptoms, and medical history. Further data is collected through medical testing, dependent on the type of treatment the participant is in a trial for.

Once this data is collected, it’s then digitized. Clinical data management systems assign numbers to patients, controlling who can see their personal information. “This process is called deidentification, where the actual data sent to government entities for drug approval cannot be linked back to individuals,” Kim explains. “This is set by global and national regulations in each country.” It’s important to note that although patient data collected cannot be traced back to individual people, physicians and study staff still have access in the case of medical intervention should a patient have a health risk or concern. This adds an additional layer of safety for patients.

As a participant, do I have the right to review my own data?

“As a patient in any medical situation we have the right to see our information. As a clinical trial participant, not all information will be available immediately unless there is an emergency regarding the health of the patient,” Kim notes. There are circumstances in clinical trials where studies require blinded data to ensure accurate results. If this is the case, that information will not be available to participants immediately. For example, if you were testing a diabetes drug and a lab value could give away which treatment group you were in, you would likely not be able to view that data until your participation had concluded.

“Clinical trials are all about collecting data in a rigorous way,” Jane summarizes. “That data is managed in a way that protects privacy and allows physicians appropriate medical oversight of the patient. Ultimately, the data is used to make decisions on the safety and effectiveness of new treatment options – we take immense care of the data to ensure its complete and accurate!”


Learn more about patient data collection by accessing the webinar recording here. View CISCRP’s library of webinars and podcasts here.

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Volunteer opportunities with CISCRP, visit our Volunteer page.

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