2 Steps for Correcting Non-compliance with EU Disclosure Regulations

The EU Trials Tracker, produced by the EBM DataLab at the University of Oxford, is now live. In light of this and an accompanying article just published on EU clinical trial compliance, we are sharing our article that originally was published in May on LinkedIn.

Background

European Union (EU) regulations require the disclosure of clinical trial results for all studies within 12 months of study completion or within 6 months for pediatric trials. Over 12,000 studies listed on the European Medicine Agency (EMA) trial register (EU CTR), conducted by biopharmaceutical companies and other industry sponsors, are overdue on results posting. Non-industry sponsors, including academic institutions, hospitals, and public health organization also are responsible for disclosing study information on the EU CTR registry. 

However, nearly 25 percent of these completed trials are missing results.  A further analysis shows that industry sponsors implementing a commercial clinical trial disclosure system have only about 8 percent of their results apparently missing, while sponsors without a disclosure system appear to be missing approximately 42 percent of their results records. While there are a few legitimate reasons why these records are not available, that ratio is high. To address this apparent non-compliance and improve the ratio of completed trials with results, we recommend the following two-step process to take control of your compliance:

Step 1: Know your studies

All interventional studies conducted in the EU since May 2004, including some pediatric studies conducted elsewhere that are part of an EU PIP (pediatric investigation plan), are recorded on EU CTR.  Many organizations struggle to produce a definitive list of trials for which they are responsible. For industry sponsors, the challenge is often tracking studies associated with acquisitions, so we recommend creating a comprehensive list of all acquired products and businesses, as well as their acquisitions, at least back to 2004. As a final step to completing this internal trial register, search EU CTR using the names of all associated organizations to find associated clinical trials.

Tip:  When searching EU CTR, remember to search for naming and spelling variations

Step 2: Take responsibility — claim, correct, assess, disclose

Using the comprehensive list of clinical trials for which your organization is responsible, contact EU CTR to claim these studies where necessary, or work with the original investigator. Next, triage the studies:

  1. Confirm that the study status and completion date on EU CTR are correct. If not, work with the local competent authorities to correct the records.
  2. List any studies ending more than 12 months ago that does not yet have results posted in EU CTR (six months if they have pediatric participants)*.
  3. For completed studies missing results, verify whether the study status and end-of-trial date are correct and:
    1. Disclose results immediately if the data are correct or if correcting the data means that results are still past due
      OR
    2. Determine that results are never due if correcting the data means results are not required.  Note: We recommend documenting this decision.

Limitations

Following this two-step process will significantly improve compliance. However, there are limitations:

  1. It is not possible to search Phase 1 studies on the public site of EU CTR if there are no pediatric participants. The primary source for these studies will be your organization's records.
  2. While some information may be out of date on EU CTR, it may take time to correct because all changes must be made through the responsible national competent authority.
  3. Some sponsors do not agree with the workarounds required to post specific results data on EU CTR (for example, posting cross-over studies or where "n/a" would be the appropriate response and therefore choosing to withhold results disclosure until these issues are addressed).

Tip: When searching EU CTR, remember to search for naming and spelling variations.

*The timing of results disclosure depends on when the study was conducted; refer to the appropriate regulations for details.

About the Author

Thomas Wicks

As TrialScope’s chief strategy officer, Thomas Wicks ensures that the company — and its customer-partners — are kept current with clinical trials disclosure regulations. With more than 17 years of experience, he is considered an expert in disclosure and transparency. He provides guidance on policies and procedures in the area of clinical trials submissions management.

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