Nature Journal on the Need for Clinical-Trial Data Sharing Regulations

Governments need to tighten regulation if the sharing of clinical-trial data is to succeed

...Governments need to tighten regulation if the sharing of clinical-trial data is to succeed. Clinical science has a compatibility problem. Although there are set protocols to test medicines and to treat patients, no such standards exist to compare clinical-trial data. The problem arises because each research group has a preferred method of collecting and categorizing results. Differences can be as great as omitting or including the gender and ethnicity of patients enrolled, or as mundane as the vocabulary used in medical records.

For example, a study published in The BMJ this week challenged the ‘weekend effect’ — the idea that people in the United Kingdom admitted to National Health Service hospitals at weekends are more likely to die compared with those admitted on weekdays — by saying that stroke patients’ conditions are frequently miscoded by UK hospital staff. If proved, such a finding could cast doubt on research studies that use medical records as a data source. The lack of a single place to report descriptive metadata compounds the problem. Data sharing is most challenging for developing countries, which often lack the resources for large-scale statistical analysis.

The latest attempt to address this problem is Vivli, described last week in The New England Journal of Medicine as a universal platform to “link existing data-sharing platforms and communities, while hosting data from investigators who aspire to share data but lack the resources to do so”. The platform, to be run by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard in Cambridge, Massachusetts, will initially employ curators to convert the clinical-trial data they receive from researchers into a standard, anonymized format and post it on the platform for other researchers to access on request...