Clinical Trial Development, Transparency, and Medical Information
Gaining the Trust of Patients

Sandra Blumenrath
DIA Science Writer

ata transparency in clinical trials is key. Allowing for public scrutiny, for example, establishes trust and confidence in clinical trials among patients. But transparency also furthers our scientific knowledge and helps us avoid clinical trial duplication. With increasing data sharing activities and more than one year of experience of publishing clinical data in the EU, sessions in this topic area focused on transparency benefits, challenges, and best practices as well as suggestions for ways to improve the use of the large amount of clinical information made public in today’s research environment.

Key Takeaways

• Use of shared data and documents for secondary research activities (or secondary analysis) is becoming increasingly popular and will drive innovation. Data sharing is facilitated both by access to documents via the websites of regulatory bodies and by access to subject-level data by other means.
• Challenges of data sharing relate primarily to the protection of data privacy rather than to issues with Commercially Confidential Information. Giving patients sufficient information about how their data will be shared responsibly is crucial to ensure their trust.
• Since information made publicly available is automatically available globally, harmonization of transparency requirements and best practices is a must.
• Informed Consents and Lay Summaries of study results can be significantly improved by avoiding jargon, complicated language, and lengthy documents.

Why this is important: Research participants drive medical product development. Without an ability to gain the trust of patients and effectively recruit research participants, there will be no clinical trials and no new medicines.

Data sharing activities and globally available clinical trial data have risen dramatically over the past decade. Nearly 200 countries are conducting clinical trials, roughly 30 key trial registries are publicly available, and more than 90 countries have at least some disclosure requirements. Yet, there are no internationally accepted disclosure standards.

The pharmaceutical industry has learned a lot about how much information is available in the public domain and cannot be removed. It is committed to advancing public health and research through meaningful, responsible clinical data transparency. With EMA Policy 0070, which was established to provide guidelines and processes for increasing public trust by allowing unprecedented access to clinical trial data, Europe seeks to help life science companies protect the privacy of trial participants. And the EU’s new General Data Protection Regulation (GDPR) that came into force in May this year, has certainly spurred life sciences firms to cement their data management strategies.

Data privacy turns out to be the primary challenge compared to compliance with Commercially Confidential Information. Data that are already publically available can no longer be removed. For patients to agree to become clinical trial participants, they need to be thoroughly informed about current data sharing practices and what those practices mean for them. Transparency will be the most direct and effective path to a patient’s trust in clinical trial procedures.

Informed Consents and Lay Summaries of study results, too, should be approached from a patient-centric angle and with the intended audience in mind. Complicated language, lengthy documents, and legal and medical terms should be avoided at all costs, and clear definitions of side effects should be provided. Important information or subtleties might also get lost in translation if documents are translated into other languages. Plain language may significantly reduce translational errors. Furthermore, patients’ expectations have to be managed by making the reader aware of the limitations of these documents.

With regard to legal boundaries, currently conflicting transparency requirements across regions are at odds with the increasingly global scale of publicly accessible data disclosures. Because of data privacy concerns and the risk of data misuse, a harmonization of transparency requirements is not only inevitable but also urgent.

This article summarizes key takeaways from sessions in “Topic F: What Can Stakeholders Expect from Clinical Trial (Development), Transparency, and Medical Information?