Over the years, technology within medical research has advance enormously, improving its methods of inputting and capturing data. When conducting clinical trials, it is crucial that current data is available throughout the study so that informed decisions can be made from start to finish.
Electronic data capture (EDC) systems manage digital data from various channels into a centralised platform, thus improving the efficiency of data capturing throughout clinical trials. Real time data (RTD) is realized through the application of EDC as data is available the instant it is entered. Further, EDC also offers significant advantages in term of the quality. With RTD, the length of time taken to complete a study can be reduced, thus accelerate drug development.
The implementation of RTD is recognized to significantly reduce clinical trial costs, in particular the number of field monitoring visits. This is because the use of RTD allows for ongoing review of site performance, instant feedback of any issues from site, site communication and record keeping which helps track and report on any trends. The features of RTD greatly assists CRAs in tracking study metrics on site performance, thus making on site visits less critical.
RTD also decreases the risk of data completion errors, allowing workflow to continue on an ongoing basis with less disruptions to the study. Clinical trials monitored through RTD also quickly identifies signals that require immediate action, and also identify trends which point to safety issues.
RTD also facilitates the activities of the independent data monitoring committee (IDMC), which evaluate any early data available. IDMC’s are given limited access to blinded data in which they can review data independently without any bias. Furthermore, IDMS are able to make recommendations to the sponsor from the information acquired, such as termination of the study due to safety concerns or futility.
Over the past years, George Clinical (GC) has managed a number of studies proving that RTD has significant advantages to the study. For instance, RTD was utilized in a study that was investigating cardiovascular risk in Type 2 diabetes patients, which was sponsored by a leading global pharmaceutical company. Through the use of RTD, the IDMCs were able to review early results and detect an undesirable effect from the compound. Through RTD, this issue was anticipated in advance, allowing the company to stop the study early on, reducing unnecessary risk to study subjects and economizing a large amount of money.
Technology is constantly discovering ways to improve the integration and evaluation of data in real time, leading to faster documenting time and instant access to updated information. Furthermore, Sponsors and other study stakeholders are able to track the study from start to finish and report from RTD on any outcomes produced in the study. In order to effectively utilise RTD, companies must be able to maintain the constant flow of incoming data, and have the resources to analyse data at a rapid rate. Errors that go undetected can quickly compromise the quality and integrity of the study. However, it is vital to recognise the importance of RTD and incorporate it in a planned, meticulous and documented manner to avoid the risks associated.