Operational Risks is the possibility of issues arising from inadequate policies or procedures, poor data quality, insufficient systems, and human error. Complying with the requirements of local and multi-national trial transparency regulations across the world requires the appropriate operational controls, training, and systems to manage the transparency processes reliable and efficiently.
For more information on the scope of global clinical trial disclosure, please refer to the previous post on Expanding Transparency.
Sources of Operational Risks
To ensure a well-controlled and effective clinical disclosure operation requires an organizational commitment to implement the systems, processes, and policies necessary to manage trial transparency. In my experience working in the clinical trial disclosure space over the past ten years, there are common sources of risk that trial sponsors have often been slow to address.
Trial information is made publicly available through many channels, including over 30 registries globally, medical journals, posters, conference sessions, and in response to requests for detailed clinical data. The published data is accessible globally to the public, which includes regulators, transparency advocates, industry critics, investors, and competitors. Poorly coordinated disclosure can result in regulatory non-compliance, embarrassing discrepancies, and the release of data that violates privacy regulations or confidential information that could limit patents.
Disclosure regulations are no longer limited to a handful of national health authorities, but have become a global requirement, mandated by agencies and foundations as a condition of grants, and a prerequisite for publication. Trial sponsors that do not establish a formal stakeholder group are at risk of disclosing poorly coordinated data that can expose their organization to a range of negative consequences.
Policies and Procedures
With the proliferation of trial disclosure requirements and the evolving transparency trends, many trial sponsors find themselves out of step with regulations and the disclosure practices of their peers.
Sponsors that still maintain transparency policies based on a minimal disclosure of data are making themselves vulnerable to negative assessments by transparency advocates. Organizations that refer to Declaration of Helsinki are committing to a broader transparency that includes posting protocols and disclosing results for all trials in humans including healthy volunteer studies, which is not always reflected in their policies.
Finally, many sponsors have not yet established standard operating procedures (SOPs) to capture and harmonize global disclosure requirements to ensure a consistent, timely and accurate global clinical trial disclosure approach. Out of date or insufficient procedures lead to poorly controlled and inefficient disclosure practices that prevent the organization from having an accurate understanding of global transparency requirements making it challenging to meet their regulatory and ethical obligations.
Data Quality and Disclosure Systems
Accurate and timely trial disclosure depends on accurate and up-to-date source data managed by a comprehensive disclosure system.
The posting of protocol information typically pulls information from the clinical protocol and a clinical trial project management system, whether that is a formal CTMS, extracts from an inhouse trial management database or a series of spreadsheets. Unfortunately, while these systems may satisfy project management requirements, accurate information needed to report protocol updates to a study registry may not be available in a timely manner.
For the disclosure of clinical trial results data sponsors rely on their clinical trial data management system (CDMS). The challenge for both industry and academic sponsors is that clinical registries require results data in specific formats that they may otherwise not use to aggregate and present information. While results data accuracy should not be an issue, the disclosure timeframes and data granularity can be a challenge for some sponsors and investigators.
Whether posting protocol information or disclosing results, most sponsors have implemented a system to manage transparency. This system may be a simple spreadsheet or a task management application, though increasingly sponsors are implementing dedicated disclosure solutions. However, some solutions may create the appearance of reliability, while actually introducing compliance risks and adding unnecessary work. The main issue with many solutions is that they are costly to keep up to date and rarely provide a comprehensive view of transparency requirements or disclosure statuses.
Operational Risk Mitigation
To mitigate these operational risks, TrialScope has developed a suite of clinical trial transparency software to provide timely and accurate visibility into global disclosure compliance, coordinate the disclosure work of all stakeholders, and support managing global disclosure.
Check out our on-demand webinar, "The Global Disclosure Challenge: What You Need to Know"
Next, we will consider the regulatory and compliance risks associated with global clinical trial transparency.