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Data Collection Method in Clinical Trials
- AS Team
- Aug 23, 2022
A Date with Data
Clinical research trials are becoming more expensive. According to a published report, a Phase III trial is estimated to cost $255 million. There could be several reasons for this, one of which is the strict regulations. Local governments and the medical industry have their own requirements, and complying with these regulations can increase costs. Furthermore, different research trials exist depending on the objective, meaning separate procedures exist. This means that when a trial is conducted, the data has to be collected quickly and accurately. Hence why many companies now use the direct data capture approach.
When designing a clinical trial, it is critical to consider how data will be collected and captured during the trial. The methodological process of gathering information about a specific subject is known as data collection. It is critical to ensure that your data is complete and collected legally and ethically during the collection phase. Otherwise, your analysis will be inaccurate, which could have far-reaching consequences. Data can be qualitative (i.e., contextual) or quantitative (meaning numeric). Many data collection methods apply to both types, but some are more suited to one than the other. Here are some of the most common ways.
Paper Case Reporting
Paper CRFs are intended for handwritten information. They are inexpensive to produce and allow for direct copies and scanning. New technology, such as optical character recognition (OCR), enables computers to 'read' data written by site personnel and automatically enter it into a database.
Electronic
Electronic methods entail entering data directly into a computer system rather than transcribing it on the CRF. The computer system can be centralized, with all sites accessing the same system via the Internet, or distributed. Each site enters data locally on its system, which is then synchronized to a central repository. In an electronic-based approach, several methods for uploading data to a centralized database exist. For example, PCs can connect to the centralized database via a modem, DSL, lease line, or PDAs and pen-based devices with wireless connectivity to the centralized database.
The most recent trend is EDC (electronic data capture), where the investigator has real-time access to a centralized database via an internet browser. The investigator can then directly enter the patient data into the database while ensuring that validation checks/rules are run against the entered data to ensure accuracy and consistency. This eliminates the need for data entry on the first pass. All of these methods are essentially paperless.
Patient Reported Outcome
All data directly provided by patients are referred to as Patient Reported Outcomes (PRO); this includes any questionnaire or diary and can be done on paper or with electronic systems. Technical tools for receiving these data in an efficient and user-friendly manner are rapidly evolving. The term ePRO is used when an electronic handheld system, such as a tablet or text messaging (SMS), is used. These electronic data are typically collected in the form of a daily diary at the patient's home or through Quality of Life (QoL) questionnaires administered during site visits.
Asking patients to provide their data electronically has several advantages: the data quality is higher, and these systems provide site staff with ongoing insight into how the patient is doing and whether the data is entered reliably or not. When using paper diaries, this is only apparent at the next patient visit when they bring the log to the site. ePROs also reduce the site staff's study data entry workload.
Wearables
There is concern that data from wearables will not be subjected to the same level of auditing as data from clinical trials. However, this should not be interpreted as a barrier to its use. Human error affecting data integrity from wearables, which will undoubtedly improve over time, can be tolerated in exchange for real-time data sent directly from patients to researchers.
Regardless of industry, big data has begun to deliver significant change. Big data offers opportunities in clinical research ranging from improved patient recruitment and engagement to more efficient trials and higher quality results.
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