Less than half of breast cancer trials registered on ClinicalTrials.gov are published in peer-reviewed journals, according to a new study published by the journal Research Integrity and Peer Review.
The authors of the study warn that:
the findings suggest the results of the majority of breast cancer trials remain unavailable to the public. These findings raise both ethical and scientific concerns and question both the completeness and validity of the evidence base that guides treatment decisions/guidelines.
The researchers who conducted the study, Innocent Gerald Asiimwe and Dickson Rumona, found that out of 340 trials listed within the study period, only 86 trials were published in peer-reviewed journals within two years of completion. The addition of a results database by ClinicalTrials.gov in 2008 to enable researchers to post the results of their trials as stipulated by the FDA Amendments Act (FDAAA) of 2007 had not improved publication rates, they concluded.
A recent STAT investigation found that while legal breaches of the FDAAA are widespread, the two agencies charged with enforcing compliance – the FDA and the NIH – have so far not sanctioned a single company or research institution that is breaking the law.
Currently, breast cancer affects approximately 12% of women worldwide. According to the American Cancer Society, in America alone, a quarter of a million people will develop breast cancer this year. Every year, nearly half a million people globally die from breast cancer, including over 40,000 people a year in the US, and over 11,000 in the UK.
Among the over 670 patient groups and professional associations that support the AllTrials campaign, a full fifty groups are working to fight cancer. Cancer Research UK support the campaign because:
Access to clinical trial data, including retrospective data and the results of current and future trials where possible, is a vital issue for researchers, patients and the public.
To fix the system the authors of the study called for effective enforcement of the existing rules, recommending:
increasing the capability of ClinicalTrials.gov to detect and enable rectification of incomplete, inaccurate or inconsistent entries … Responsible authorities should be made accountable for complete, accurate and up-to-date information. ClinicalTrials.gov should retain contact information for completed (especially unpublished) trials. The trial registry should also include a field that enables viewers to determine whether/not a study is required to post results as mandated by FDAAA. There should be enforcements (rewards and punishments) at all levels; e.g. Institutional Review Boards, peer reviewers or journal editors should not respectively approve, approve for publication or publish (unless otherwise/justifiable) applicable trials that are not prospectively registered, do not have trial registration numbers or have not posted results as required by the FDAAA (many published trials did not fulfil these requirements).