As many as five out of 10 clinical trials fail to make it past phase three of research, even as it costs almost $40m–around 50% of the average trial budget–to reach that stage. And trial complexity continues to grow, with the number of procedures per protocol increasing significantly in the last few years.
To add to the woes of pharmaceutical and biotechnology companies, medical device manufacturers, and contract research organizations (CROs), regulations on trial data quality oversight keep getting stricter. For example, the so-called 21 CFR Part 11 rule introduced by the U.S. Food and Drug Administration (FDA) mandates sponsors and CROs to enact robust controls over electronic records and electronic signatures (ERES).
These controls, ranging from systems validation and authorized system access to secure and computerized audit trails, are designed to guarantee the integrity, authenticity and confidentiality of clinical data. A major reason for the tougher compliance regime is the recent failure of many submissions during the first-cycle review, on account of data discrepancies and high-profile fraud cases.
Clearly, life sciences organizations today face rising pressure from consumers and policy makers to make sure trial data and published findings are accurate and credible, and to protect the rights and privacy of subjects.
Data drives outcomes
For the industry to successfully address these imperatives, access to accurate information is crucial. Provisioning of high-quality data can help clinical teams take better informed and proactive decisions that shorten the trial lifecycle, and reduce associated risks.
Beside accuracy, integrity of data is vital, too. After all, data quality issues may compromise the reliability and validity of the study findings, which in turn makes decision making around medicine usage and marketing-related product evaluation trickier.
Moreover, a failure to effectively manage the subject and operational data used during the formulation of new medical approaches can significantly impact the overall design, execution, quality and management of trials.
All sponsors do realize the importance of institutionalizing robust trial data quality. However, many research teams typically manually compile crucial trial-related data obtained from disparate sources into reports, which become outdated by the time the Clinical Operations decision maker reviews them. Also, these disparate systems represent silos of information that are used by a variety of stakeholders for gathering, accessing and managing data in a duplicated manner.
The second notable challenge faced by clinical data managers is the recent explosion in the volume of unstructured data. Earlier, trials relied purely on structured, clinically-sourced data that was comparatively easy to process and analyze. However, companies are now increasingly leveraging a wide range of unstructured data from multiple real-world sources such as EMRs, genetic and phenotypic profiles, and connected mHealth devices. And, sourcing, aggregating and mining the same in an effective manner has become an arduous task for many organizations.
How can then pharma companies, medical device makers and CROs address these challenges, and mitigate various data quality issues arising out of fraud, misconduct, deliberate or inadvertent noncompliance, or significant carelessness?
Clinical trials are only going to get more complex as the consumerization of health care gains further momentum. Life sciences companies must aggressively revamp core business processes and systems related to clinical data management, in order to reduce costs, shorten time to market, boost veracity of results, and conform to onerous regulations. Improving trial data accuracy and integrity should be the first step in that direction.
In any clinical trial, data is a critical component that can significantly impact the entire project in terms of end-to-end turnaround time, costs, and efficiency. Today, with technological advancements powering clinical data management, it may in fact even have a role in determining the overall success of a project.
For clinical research organizations (CROs) and the broader pharmaceutical industry around the world, drug development remains a complex and costly process spread across multiple sites. Clinical trials form an essential part of this process, lasting many years and costing millions of dollars.
Leading pharma regulators such as the U.S. FDA continue to impose, and enforce, strict compliance standards with regard to approval of new drugs. The U.S. watchdog’s strict vigil means that for every new medical device or drug securing market release, thousands get rejected – cumulatively representing billions of dollars, and years of research.
Copyright @ 2021 Acceliant - All Rights Reserved