Regulatory Risk is the possibility that changing regulations will significantly affect the organization, requiring additional investments, changes in operations, or other adjustments to address competitive and compliance issues. The related Compliance Risk is the potential that your organization is in violation of regulatory requirements leading to fines, reputational impacts, and even delays or denials of regulatory approvals. In the context of clinical trials transparency, this means anticipating, interpreting, and tracking global regulatory requirements, continuously monitoring compliance, and coordinating disclosure across departments, partners, and affiliates.
In considering these risks, we use a slightly broader definition of ‘regulations’ to include transparency requirements established by non-governmental groups that may affect an organization’s ability to run trials, publish in peer review journals, or meet policy commitments. For example, the Declaration of Helsinki requires the disclosure of clinical data for all trials in humans and leading medical journals have established the prospective posting of protocol information is a prerequisite for publication.
For more information on global clinical trial disclosure, please refer to the previous posts on Expanding Transparency about the increasing scope of disclosure, and Uncontrolled Transparency looking at the associated operational risks associated.
Sources of Regulatory and Compliance Risks
To mitigate regulatory and compliance risks requires visibility into the evolving transparency regulations and a thorough understanding of how these requirements must be met. Meeting these developing transparency mandates assumes the ability to track compliance and coordinate disclosure processes and data across the organization. However, too often the collecting and interpreting of regulations is still assumed to be the responsibility of local affiliates, partners, contract research organizations (CRO), or sites. While those all have a role in monitoring local regulations, global organizations are at risk when they fail to establish a clear ownership of a coordinated approach to transparency and data sharing.
There are more than 30 trial registries and over 90 countries with clinical transparency requirements, not counting the many funders of research, medical associations and others who require trial disclosure. The key to managing regulatory risks is anticipating changes to requirements early enough to allow time for working with regulators on refining the legislation and to establish the processes and systems to minimize the work needed to meet the new requirements. Similarly, assuring compliance with established transparency regulations requires the ability to track the disclosure status of each study in relation to each requirement. This visibility into the changing mandates and the ability to track compliance globally is frequently still missing, with organizations relying instead on local efforts without centralized regulatory and compliance monitoring.
As new transparency obligations emerge and existing regulations evolve, it is necessary not only to track these changes but also to analyze and understand them. While many of the regulations appear straightforward at first glance, a deeper assessment quickly reveals unexpected complexities and nuances that make it a challenge to interpret and operationalize them correctly. For example, a group of transparency experts took over six months to interpret the impact of a recent amendment to the disclosure regulations in the US across a range of specific scenarios. Although most transparency regulations are not as comprehensive as those in the US, a systematic approach to assessing them and developing coordinated global policies and processes is necessary. We have seen mistaken interpretations of transparency regulations lead to non-compliant disclosure practices, and all too often it was because of an incomplete understanding of the full scope of the requirements.
To manage the regulatory and compliance risks associated with transparency it is essential to have a clear ownership of disclosure. Without an overall owner of transparency, perhaps supported by a steering committee in larger organizations, there is no reliable way to ensure a coordinated and compliant approach to disclosure.
We see organizations where executives assume that the individuals or teams tasked with managing disclosure have visibility and control over these processes across all applicable registries and websites. However, these disclosure specialists are instead focused on ClinicalTrials.gov and EU CTR, without tracking the regulations and compliance status of disclosure through other channels. Typically, this disconnect between expectation and reality is because the specialists were originally charged with managing disclosure in the US and EU, but over time the organization has not adjusted the scope of these responsibilities, nor made the necessary investments to support the expanded work.
Instead of establishing a clear transparency owner, some organizations decide that disclosure is the responsibility of each local affiliate, partner, or CRO. In the best-case, this approach may result in compliant disclosure, though without anyone in the organization having a clear understanding what data are disclosed, where they are available, or whether the data were disclosed in compliance with local laws and corporate policies.
Regulatory & Compliance Risk Mitigation
To mitigate these regulatory and compliance risks, TrialScope has developed a suite of clinical trial transparency software solutions to provide timely and accurate visibility into global disclosure compliance, coordinate the disclosure work of all stakeholders, and support managing global disclosure.
Reputational and Brand Risks
Next, we will consider the risks to the brand and reputational standing associated with global clinical trial transparency.