FDA Issues a Transparency Roadmap: What Changes for Clinical Trial Disclosure, and What Does Not

The roadmap covers five areas ranging from complete response letters to food labeling. The area most relevant to disclosure says the FDA aims to support independent research by increasing post-approval scientific data disclosures.

By Francine Lane

What did the FDA announce? The US Food and Drug Administration (FDA) released a Transparency Roadmap on Oct. 2, an FDA Voices post setting out fiscal year (FY) 2026 milestones and FY2027 priorities. For clinical trial disclosure, the relevant items are the FDA’s aim to publish clinical study reports (CSRs) for approved applications and align with European Medicines Agency (EMA) data transparency “where feasible,” and its continued push to increase ClinicalTrials.gov compliance.

Why does it matter for clinical trial disclosure and transparency teams? CSR publication would move the US closer to the EMA’s Policy 0070 and Health Canada’s Public Release of Clinical Information (PRCI), which have published CSRs for several years. But the US and EU define personal data and confidential commercial information differently, so their redaction standards could make different data public from the same CSR. The FDA has not said when it would publish CSRs or what redaction standard it would use.

On ClinicalTrials.gov, the roadmap changes no requirements or penalties, but it ties the FDA’s compliance outreach to concerns about gaps in the public record and publication bias.

Who is affected? For CSRs, this may impact sponsors whose CSRs are already public outside the US, such as through the EMA or Health Canada.

For ClinicalTrials.gov, any sponsor with applicable clinical trials should continue to submit their required results within 12 months of primary completion date, unless a request for a delay is submitted.

What should sponsors do? Nothing in the roadmap creates new requirements. Sponsors filing in the US and ex-US should plan now to keep any public versions of a CSR as aligned as possible, starting with how the CSR is written. All sponsors should continue to confirm required results are posted to ClinicalTrials.gov.

If you want more details, keep reading, but above are the key takeaways for clinical trial disclosure and transparency teams.

What the Roadmap Says About CSRs

The roadmap, developed by FDA Acting Chief of Staff Lowell M. Zeta, covers five areas ranging from complete response letters to food labeling. The area most relevant to disclosure says the FDA aims to support independent research by increasing post-approval scientific data disclosures. That includes publishing CSRs for approved applications, aligning with EMA data transparency practices where feasible, piloting expanded clinical dataset transparency, and enhancing post-marketing data disclosures.

The roadmap creates no new disclosure requirements. It does not give a redaction standard, a timeline, or a scope beyond “approved applications.”

The FDA piloted CSR publication in 2018 through its Clinical Data Summary Pilot. The pilot drew one volunteer sponsor and was closed in 2020.

What Changes, and What Does Not

CSR publication already happens outside the US

The EMA publishes clinical data under Policy 0070, relaunched in September 2023 and expanded in 2025. It publishes regardless of outcome, including negative opinions and withdrawals. Under the EU Clinical Trials Regulation (EU CTR), marketing authorization (MA) holders also submit CSRs to the Clinical Trials Information System (CTIS) within 30 days of an MA decision. Health Canada publishes clinical information under PRCI. The EMA and Health Canada use a shared anonymization report template and a work-share arrangement for packages common to both agencies.

A US version would differ in two ways.

• Scope: The FDA says approved applications. The EMA publishes regardless of outcome.
• Redaction: The EMA and Health Canada coordinate their redactions, but US and EU definitions of personal data and confidential commercial information differ. An FDA-published CSR could make different data public than the EMA and Health Canada versions.

For sponsors filing in more than one region, that could mean the same CSR is public in two versions, with information withheld in one and visible in the other. Which agency publishes first will vary by product.

ClinicalTrials.gov compliance continues

The roadmap says the FDA is working to increase compliance with ClinicalTrials.gov reporting requirements, citing gaps in the public record and publication bias that overrepresent successes and underrepresent  failures. It links to the FDA’s March 30 outreach to more than 2,200 sponsors and researchers associated with more than 3,000 trials that appeared to be missing required results.

The FDA continues to publish its ClinicalTrials.gov enforcement actions. As of Oct. 8, 2026, it had posted 246 pre-notices of potential noncompliance issued since 2013 and eight notices of noncompliance. Notices of noncompliance also appear on the study record in ClinicalTrials.gov, where users can filter searches for Food and Drug Administration Amendments Act (FDAAA) 801 violations.

What Else Is in the Roadmap

Complete response letters

The FDA has published complete response letters (CRLs) since July 2025 and committed to real-time release that September. After a citizen petition in April 2026, the US Department of Health and Human Services (HHS) temporarily paused releasing CSLs, but by July, new CRLs appeared on the FDA’s CRL database. The roadmap says the FDA aims, through rulemaking, to disclose the fact of submission of major applications. The FDA’s regulatory agenda ties that change to proactive disclosure of CRLs for unapproved products, with a proposed rule listed for October 2026.

The FDA’s case for publishing CRLs rests on a 2015 FDA analysis of 61 letters, which found sponsor announcements often left out the agency’s stated safety and efficacy concerns. Of seven CRLs citing increased mortality, one corresponding press release mentioned it.

The SEC

The FDA and the Securities and Exchange Commission (SEC) signed a memorandum of understanding (MOU) on Aug. 31 formalizing how the FDA can share nonpublic information with the SEC. The agencies have shared information for two decades. The roadmap presents the MOU as a transparency measure.

What to Do Now

• Identify affected programs: Know which upcoming US approvals are for products also filed with the EMA or Health Canada
• Understand the definitional differences: Compare how the US and EU define personal data and confidential commercial information
• Plan for aligned redaction: Set a strategy that keeps US and ex-US public versions as consistent as possible
• Write CSRs with publication in mind: Limit personal data and confidential commercial information in sections likely to be made public
• Continue to confirm ClinicalTrials.gov results are posted: The FDA’s outreach shows results reporting remains a compliance focus.