Prospective Writing to Prepare Disclosure-Ready Clinical Trial Documentation
Throughout the course of a clinical trial, numerous types of documentation are collected and transformed into regulatory submissions, publications, and reports to answer specific research questions. The configuration of clinical documentation to meet regulatory requirements and target audiences often leads to time-consuming duplicate efforts. In addition, sometimes the clinical data utility of documentation is compromised while adapting it to regulatory requirements. Therefore, prospective writing approaches are being used to plan for data transparency requirements in later stages of clinical development.
Adopting a prospective writing approach can lift the burden of voluminous regulatory and scientific submissions amidst evolving global data-sharing legislation. While clinical documentation varies in purpose, format, and audience, each document is interlinked—one acting as metadata to another. The basic concept of a prospective writing approach is being proactive in each stage of a clinical document lifecycle and identifying links between documents. In this way, a strategically planned document developed at an initial stage can work as a source for creating more refined documents at later stages. For example, a clinical study report can be written while visualizing the requirements of a wider preparation of disclosure-ready documents (e.g., clinical data sharing, protocol and results posting, plain language summaries). A clinical study report can be proactively anonymized while initially authoring as per the applicable data-sharing requirements wherever possible. Consider individual subject data presentations that maintain data meaning, remain in context, and conform to current standards for deidentifying data. This will not only minimize the need to redact the same clinical study report at the time of submission but also retain the data utility of the document. This both eliminates time-consuming extraneous processes and improves cost effectiveness. Further, prospective writing can reduce the risk of reidentification of sensitive data with prospective redaction initiatives.
In “Clinical Data Transparency & Public Disclosures: Overcoming Challenges with Prospective Writing,” we discuss the prospective writing initiatives that can be used to prepare clinical documentation to support future disclosure initiatives while also safeguarding patient privacy.
For more information on this topic, contact us at medicalwriting@transperfect.com.
