The following is a guest blog by Thomas Wicks, Chief Strategy Officer at TrialScope, a company that helps clinical trial sponsors to improve their disclosure capabilities
European Union regulations require the disclosure of results for all clinical trials within 12 months of completion or within 6 months for paediatric trials. Shockingly, results are missing for nearly 80% of the roughly 3,200 completed trials that had been conducted by non-industry sponsors.
Source: Data and visualization by TrialScope [data not verified by TranspariMED]
Non-industry sponsors, including academic institutions, hospitals, and public health organization are responsible for disclosing study information on the EU CTR registry. Not only are many trial results records unavailable, but it seems likely that many more studies were registered on EU CTR, but then never updated as required.
For example, almost 5,600 non-industry studies initiated more than five years ago still appear to be ongoing without a completion date (over 1/3 of these ‘ongoing’ studies are at least 10 years old). Although some of these older studies may indeed still be ongoing, clinical trials usually complete within 2½ to 3 years, so most of these ongoing trials have likely ended without a public update on EU CTR.
While there are a few legitimate reasons why results records for apparently completed trials are not available, that ratio seems too 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 compliance:
Step 1: Know your trials
All interventional trials conducted in the European Union since May of 2004, including some paediatric trials conducted elsewhere, are recorded on EU CTR. However, non-industry sponsors often lack their own comprehensive list of all trials conducted by their investigators since 2004.
Creating this list may require working with Institutional Review Boards or ethics committees to track down all interventional trials of the past 14 years, reaching out to the various departments, schools, and hospitals to verify the data. As a final step to completing this internal trial listing, we recommend searching EU CTR using the names of all associated organizations, departments, and investigators to confirm that no trial is overlooked.
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, work with the original investigator or contact EU CTR to claim these trials where necessary.
Next triage the trials:
Confirm that the trial status and completion date on EU CTR is correct. If not, work with the local competent authorities to correct the records.
List any trials that completed more than 12 months ago that does not yet have results posted in EU CTR (6 months if they have paediatric participants).
For completed trials that are missing results verify whether the trial status and end-of-trial date are correct and:
Disclose results immediately if the data are correct (or if correcting the data means that results are still overdue)
Determine that results are never due if correcting the data means results are not required. Note: We recommend documenting this decision.
While following this two-step process will significantly improve compliance, there are limitations:
It is not possible to search Phase 1 trials on the public site of EU CTR if there are no paediatric participants. The primary source for these trials will be your organization’s records.
While some information may be out of date on EU CTR, it may take time to correct since updates are made through the responsible national competent authority.
The content of this blog, which was originally published on LinkedIn, is the sole responsibility of Thomas Wicks. Universities interested in improving their reporting performance should also consult this blog by TranspariMED and review the material currently being uploaded onto the new Clinical Trials Registration and Results Reporting Taskforce website.