Clinical trials are conducted to demonstrate the safety and efficacy of new drugs, procedures, or devices. It can’t be overstated how important it is to ensure and uphold data integrity in clinical trials.
Regulators require complete and accurate data to assess the efficacy and safety of what’s being studied to evaluate dosing recommendations proposed by the drug developers, and to reproduce and validate the clinical findings in subsequent studies.
Data integrity helps to safeguard the voluntary participants who have placed their trust in the clinical trial process and patients who will ultimately be taking the medications once they have received regulatory approval. When data integrity has been compromised, it may undermine public confidence in the entire drug development and clinical trial process, and can have a lasting negative impact on the drug company and trial investigators involved in the process.
The U.S. Food and Drug Administration has established a handy acronym as a reminder of the key aspects that demonstrate data integrity in clinical research: ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate). In recent years, four additional attributes have been added to highlight other important aspects of this challenge: Complete, Consistent, Enduring, and Available (known as ALCOA+). These have been added to emphasize that the data should also be whole, consistent (in terms of including the date and time of all activities), lasting throughout the lifecycle, and readily available for review or inspection.
Best practices are emerging
In recent years, a number of best practices have begun to emerge to maximize data integrity throughout the clinical trial process:
Establish consistent definitions for types of data. Efforts should be made to establish consistent, systematic definitions for the types of data that will be collected and analyzed during all phases of a clinical trial. These include developing consistent definitions and terminology related to, for instance, safety data, sampling procedures and data, clinical endpoints, side effects and adverse events, and more.
Create systems that enable credible audit trails. A big challenge for trial sponsors and investigators is to maintain robust audit trails for data that is being collected, analyzed, and shared across increasingly disparate locations and computer systems. Many clinical research organizations (CROs) are able to design and implement data capture systems that create a reliable audit trail for source data collected throughout the clinical trial.
Such audits can help to identify missing or incomplete data, data discrepancies and outliers, protocol violations, as well as systemic or significant errors in data collection, breaches in operating protocols and reporting at a site (or across multiple sites), and more.
Use security to control access to the data. To safeguard data integrity, controls must be put in place to limit access in terms of who has permission to record, revise, and delete data during the many phases of a clinical trial, to limit access to those who are not executing related tasks, and to bar those who may have a conflict of interest. User access rules should be reviewed and updated periodically, to ensure that access is limited to only those individuals who require it.
Take steps to safeguard blinding efforts. Randomization and blinding are techniques used during clinical trials to validate the true clinical impact of the investigational therapy or medical device compared to a placebo. If the blinding process fails (that is, when trial investigators or patients learn details of the particular treatment they are dispensing or receiving that was supposed to remain blinded), biases can have unintended effects on the interpretation of data.
Data management systems and data repositories that could reveal the actual treatment assignments must be rigorously managed to ensure blinding. Similarly, breaches of the blinding must be addressed and handled promptly.
This blog is intended to be informational in nature. The information and other content provided in this blog, or in any linked materials, are not intended and should not be construed as medical advice, nor is the information a substitute for professional medical expertise or treatment.
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