Clinical trial disclosure requirements are growing globally with regulations in over 90 countries and continuously evolving data sharing norms based on increasing transparency. In this dynamic environment it can be challenging to develop relevant SOPs, but here are 5 best practices based on over a decade of experience working with the leading trial sponsors.
1) Implement a Clear and Generous Transparency Policy
The best way to ensure alignment across the organization and communicate the corporate commitment to transparency, is to implement a global data sharing and transparency policy that is both specific and generous in anticipation of rapidly evolving trends.
Note: Developing a policy that anticipates transparency trends and peer commitments, as well as the evolving expectations of transparency advocates and patients may require working with an external disclosure expert.
2) Create a Cross-Functional Clinical Transparency Committee
Foster coordination and commitment across departments and regions by creating a cross-functional panel of disclosure stakeholders. Such a panel, or committee, would typically consist of the Chief Medical Officer (or representative), clinical operations, biostatistics, publications, and regulatory affairs, although others may need to be included to meet the needs of your organization.
3) Focus SOPs on High-Level Processes, Roles, and Responsibilities
Since regulations and transparency trends continue to evolve, TrialScope recommends keeping SOPs at a high-level to outlines the processes, roles, and responsibilities for disclosure. These high-level SOPS would then be augmented by supporting documents (see next point) to address specific details. This will reduce the often-cumbersome effort of updating and approving SOPs as disclosure and transparency requirements evolve.
4) Move Detail to Supporting Documents
Having a high-level SOP requires detailed supporting guidance documents, work instructions, process diagrams, and detailed roles & responsibilities charts (e.g. RACI diagrams). These detailed documents are usually less onerous to update and would include information that is likely to evolve over time, such as manual and automated processes, source systems, disclosure technologies, trial registries, and data sharing platforms.
5) Updating Related SOPs
Don’t focus exclusively on disclosure and transparency SOPs. Disclosure and transparency is reaching into many unexpected areas of an organization. Consider updating SOPs that are related to disclosure. For example, full protocols are becoming public, albeit lightly redacted. Does your protocol SOP include the best practice of including the disclosure team in the protocol finalization process to ensure that the document is appropriate to be in the public domain? Other areas that my need consideration are publications, investor relations, medical information, and regulatory affairs.
As clinical disclosure requirements continue to evolve, you can keep your organization ahead of the curve by considering these 5 Best Practices. For more information and to discuss TrialScope’s Advisory Services, please contact: firstname.lastname@example.org.