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To manage the growing scope and complexity of global disclosure regulations and trial transparency initiatives, companies are advised to create a cross-functional clinical transparency committee.
A consistent and reliable approach to the increasing public availability of clinical trial data is dependent on a clear corporate policy and thoughtful coordination across the organization. To develop the necessary transparency policy and to ensure compliant and globally harmonized disclosure requires the active involvement from leaders across the organization collaborating through a cross-functional transparency committee.
While it is common to think of clinical transparency in terms of disclosure regulations and trial registries, the truth is that clinical trial data is made available through many other outlets, including publications, corporate or health advocacy websites, and direct communications to patients or healthcare providers. The challenge is to coordinate the disclosure of data so that the publicly available information is globally consistent, timely, and accurate. However, the timing and detail of the disclosed data varies considerably based on legal obligations, commitments, and communication priorities making consistent disclosure difficult.
The key to consistent and efficient disclosure is to involve the right stakeholders throughout the data sharing lifecycle, from developing the corporate policies and processes, to coordinating disclosure requirements with the publication plan. We recommend including an executive from each of the following groups:
· Chief Medical Officer (or representative)
· Disclosure and transparency
· Clinical Operations
· Regulatory Affairs
· Publications/medical writing
On occasion, the committee may seek advice from patient advocates and internal departments such as clinical development, investor relations, and IP attorneys, though these are typically not permanent members of the committee.
The primary role of the transparency committee is to establish and promote the corporate transparency standards and facilitate cooperation across the organization. While the committee is not expected to manage the day to day disclosure operations, individual members will typically have direct involvement through their departments. The primary role of the clinical transparency committee is to:
1) Shape disclosure commitments to provide value to patients beyond mere regulatory compliance.
2) Develop a clear transparency policy that details the scope and timing of disclosure commitments.
3) Promote a culture of transparency and resolve departmental or regional differences.
4) Monitor compliance with regulatory requirements and policy commitments.
5) Advocate for adequate and consistent investment in disclosure resources and systems.
An engaged transparency committee helps connect an organization’s patient engagement goals and publications’ priorities, with disclosure regulations and transparency trends to help the organization adapt to the evolving requirements.
Thomas Wicks, Chief Strategy Officer at TrialScope