Data integrity has always been critical to the success of clinical trials. You need to have robust data capturing and evaluation strategies that ensure integrity which will help you make the right decisions. EDC systems have entirely transformed the data collection process, and it has empowered clinical researchers to conduct better and more effective trials by avoiding missing data in clinical trials.
Missing and incorrect data has the potential to disrupt the clinical trial completely. It is essential to take robust measures and implement robust technologies such as clinical data EDC systems to ensure data validity, integrity, and reliability. Modern research institutes, pharma labs, and medical equipment manufacturers deploy robust strategies to deal with the missing data problem. Let’s briefly look at the methods of handling missing data in clinical trials and how EDC systems can help ensure data accuracy and integrity.
Methods to Handle Missing Data
There are specific methods you can use to handle missing data. The first is the complete case analysis method used in exploratory studies or the initial phases of drug development. However, due to its limitations, it can’t be used as the primary source of analysis in confirmatory trials.
You can also consider using the single imputation method, which replaces a missing data point with a single value, and trial analyses are conducted under the hypothesis that all data was collected and observed. Single imputation has further variants in the LOCF, BOCF, WOCF, and the mean substitution method.
Other methods include inverse probability weighting, likelihood-based analysis, event time analysis, non-responder imputation, and multiple imputations. All methods are applicable in different environments, and you need to have a robust understanding of your trial and its purpose to apply the appropriate method to have the desired results.
EDC and Data
Modern EDC systems have completely transformed the way clinical trials operate. They have introduced a seamless data collection process that ensures that clinical trials are conducted optimally, which ultimately aids in developing medicines and tools needed for quality healthcare.
Numerical data validation, remote monitoring, medical coding, and automation are some of the tools that are used extensively in EDC systems. Data accuracy is of utmost importance during a clinical trial, and you can’t afford to compromise on data integrity and reliability as it may trigger an FDA inspection.
One of the most significant benefits of using an EDC clinical trial system within your setting is its high data accuracy and integrity. In saying that, you’re responsible for the data input that goes into the EDC system. You should also use an EDC system if you’re looking to save time. Once all the data has been collected, preparation and refinement for statistical processing don’t take much time.
Where To Find EDC Software?
If you’re looking for electronic data capture (EDC) systems that can help you cut costs and improve the efficacy of your clinical trials, then check out the products at ClinicalPURSUIT. We are pioneers in providing quality medical technology and have helped several organizations implement robust systems.
Our state-of-the-art products and services list includes Randomization and Drug Supply Management, Intelligent Electronic Data Capture System, Clinical Trial Data Management Services, Electronic Patient-Reported Outcome Software, etc. Schedule a one-on-one free demo today!
