Clinical teams face increasing pressure to adapt to recent advances within trial transparency. Clinical trial transparency now incorporates sharing redacted and anonymized patient data and writing plain language summaries to the existing registration and results disclosure of information published across databases worldwide. Throughout this evolving landscape, sponsors face ongoing challenges meeting regulatory submission deadlines while balancing disclosure of sensitive asset information and maintaining patient privacy. This presents new opportunities for establishing an effective transparency strategy to manage these various requirements.
Sponsors best positioned for meeting these requirements incorporate transparency into their clinical planning and development before the start of a new study. Many forward-thinking companies now look beyond minimum regulatory requirements and strive for patient connectivity when communicating public information with study participants. Some important things to remember when developing a transparency strategy include:
- Keep the end in mind. During early development, study planners determine key hypotheses for study design. Information from the protocol drives study registration and results reporting obligations. A study’s primary and secondary endpoints form the basis of most disclosure reporting requirements worldwide. Writing specific endpoints and analyses in the protocol ensures consistent scientific aims are communicated from study registration to final publication and protects against unanticipated exposure of proprietary information. While disclosure should not drive the science behind protocol development, medical writers and transparency associates with expertise in disclosure requirements are well positioned to advise on the right balance between necessary disclosure and protection of key assets.
- Establish appropriate guardrails. Clinical teams can ensure that assets and interests are protected by developing a consistent and strategically tailored disclosure plan. Allowing room for further exploration of potential new discoveries during the study process can be done without creating the need for required disclosure of that very information. For example, teams can develop policies for disclosing only key inclusion and exclusion criteria in regulatory and registry submissions to avoid listing supplementary information that reveals competitive intelligence.
This is an especially important consideration for companies that purchase or divest assets during development, as assets may have particularly sensitive information buried within areas of the protocol inadvertently disclosed on a public registry. Acquiring companies or investors may perform additional diligence in further developing the asset and will scrutinize the required disclosures based on the protocol design.
- Consider the full range of transparency deliverables. Regulatory disclosures are only one component of transparency standards. During study planning, think about how study results will be communicated to participants. Participants in clinical studies have made it clear that receiving a summary of their study results is extremely important to them. Meanwhile, there are looming regulations to enforce the creation of plain language summaries of clinical study results. With both regulations and the patient interest in mind, plain language summaries should educate participants and the public in an easy-to-understand manner that includes key disclosures available in public databases. Patient-forward transparency can not only influence recruitment and retention, but can also build and maintain public trust in clinical research.
- Safeguard shared data. Building successful and comprehensive data sharing strategies within organizations takes planning and patience. Staying current on data sharing initiatives, establishing informed internal teams, and having tools in place for implementing best practices in anonymizing participant data are important steps to seamlessly manage retrospective and proactive requests to disclose clinical data and documents. Understanding the complexities around regulatory requirements for submitting anonymized data as part of marketing authorization applications—including what is and is not accepted by regulators as company confidential information, as well as having a company policy on voluntary data sharing activities –helps safeguard that all public disclosures are aligned between various activities, from protocol registration to product approval. Consider working with a partner that can anonymize data using software, as well as experienced and cross-functional staff. This ensures successful execution of data sharing tasks while maintaining the highest standards of safeguarding participant privacy and commercially confidential information.
It is important for investigators and study sponsors to understand and monitor the requirements, timelines, and working methods of clinical trial disclosure on a global scale. Adherence to a comprehensive disclosure policy not only ensures regulatory compliance, but also protects intellectual property, instills a transparent corporate image, and facilitates the communication of important scientific findings to patients and the public. From registry postings to document publication, and from lay summary writing to data sharing and anonymization, the future of clinical trial conduct will be increasingly transparent.
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