Clinical Trial Results Reporting
In early November 2016, Ben Goldacre and Anna Powell-Smith launched the TrialsTracker website. This website analyzes data from ClinicalTrials.gov to determine which studies appear to be missing clinical trial results.
TrialsTracker is currently focused on sponsors with more than 30 trials, assessing the results disclosure status for interventional phase 2, 3, or 4 trials registered on ClinicalTrials.gov that were completed between 2006 and 2014 (24 months prior to the current date). The expectation on the TrialsTracker site is that study results are available within two years of study completion on ClincialTrials.gov or that a published article can be found on PubMed referencing the ClinicalTrials.gov issued identification called an NCT ID, unless a formal request to delay results has been submitted to ClinicalTrials.gov.
While there may be limitations to this analysis, such as not crediting sponsors for posting results on their corporate websites, ClinicalTrials.gov is considered by many to be the primary global registry for clinical trials where is it relatively easy to analyze clinical data and disclosure practices. If you don’t look good on ClinicalTrials.gov, you may not look good to the public.
What can you do to make your organization look better to TrialsTracker and by extension, to the public?
- Update your study information. Make sure that your Primary Completion Date and Study Completion Date are accurate and current.
- If your study is for an unapproved product or indication (use), and you don't plan to submit results within 12 months of the primary completion date, submit a formal request to delay the results, known as a Certification of Delay.
- If at all possible, disclose your results on ClinicalTrials.gov. The reality is that you often won’t get credit for posting study results to your own website, in part because nobody knows to look there.
- If you do post results to your website, include a link to the results in the ‘Links’ section of ClinicalTrials.gov. Make sure that the URL points to the specific study results (not generically to your organization’s clinical trial site, or worse, the homepage of your organizations website). Make it easy for people to find them. Clearly indicate that this link is to study results in the description. Make it short and clear – people who are not in the industry do not know what a CSR Synopsis is. They may not know that a Clinical Study Report means results.
- Add references and citations to your record at ClinicalTrials.gov and indicate if it is a results reference. While ClinicalTrials.gov does insert publication references when someone reviews a study on ClinicalTrials.gov, these references and citations are not a permanent part of your record, which means that when 3rd parties download the data for analysis, only the citations and references that you add to the record are available for analysis.
- Make sure your articles include references to the relevant NCT IDs. This will enable TrialsTracker and others to associate the journal article with your study.
- Contact the journal that published the article to reference the correct NCT IDs in their metadata. This will allow PubMed searches to find the articles associated with a study more easily.