By Clinical Informatics Staff

September 8, 2016 | In his latest blog post Ewan Birney calls for a change of procedure when it comes to clinical trial data sharing. Presently the concept of sharing research is frowned upon in some scientific circles, including the field of clinical trials. Birney’s lengthy post details the reasons why data sharing is imperative to the advancement of scientific data. He states his thesis early in his post: “I’d like the clinical trials community to shift its default position on data sharing and reuse to align to data availability on publication, similar to the life science community.”

This conversation is nothing new, though it has been reignited thanks in part to an editorial published this past January in The New England Journal of Medicine. Currently the system of data sharing is rigidly sparse. Birney says that some medical journals view data sharing as almost parasitic, and a convoluted embargo procedure is the only way to access data from some clinical trials.

According to Birney, the act of sharing data has been a tradition going back to the beginning of genetics. He points to innovations in the past century, such as the Protein Data Bank, the ENA Bank (formerly EMBL), and GenBank nucleotide collections, and the Human Genome Project as examples of instances where data sharing worked to positive, successful results. Birney is no stranger to the data sharing debate; he was appointed the joint Director of EMBL-EBI in 2015, and awarded the Benjamin Franklin Award for Open Access in the Life Science in 2005.

Birney argues that the pursuit of data in the field of clinical research should be done in the hopes of sharing information that is discovered, and the individual benefits from clinical research are secondary. “Data release is not about rewarding a single PI,” Birney says, “it’s about benefitting the clinical research community as a whole, and making the most of the data entrusted to you by patients.” In his eyes, the ultimate goal of clinical trials is to improve the lives of the patients, and this goal is most easily accomplished when data is shared. As Birney puts it: “If we’re not doing all this research to improve patient care, then probably we should change the consent process.”

Data sharing also maintains the integrity of scientific inquiry. Sharing information has been a crucial step in the history of scientific discovery, according to Birney, as he believes the step of presenting evidence alongside declaration helps weed out the bad hypotheses from the good ones. He expounds upon this by saying, “Evidence is the backbone of scientific discourse, so it follows that papers without data can be easily dismissed as well-articulated speculation.”

There is also an accountability issue in Birney’s argument. He claims that if a researcher bears in mind that their research and data will be observed and scrutinized by their peers and the public, then they will attend to their research with rigorous detail. This system of peer-review is something Birney says is “fundamental to the scientific process.” The described mentality also enforces a healthy exchange of knowledge and, as Birney puts it: “When an entire community does this, it benefits from a deeper consensus on what a ‘good study’ looks like.”

Birney admits that there are some cases in which data sharing is perhaps not simple and easy. These circumstances include patient consent, or lack thereof; when the reliability of a successful transfer of data is called into question; and if regulations within individual clinical trials prevent researchers from discussing their findings

Despite these instances, Birney advocates for continued conversation about data sharing. His closing remarks are optimistic, stressing that what makes this debate different from myriad other discussions that seem to go nowhere is the fact that the people having this conversation base their arguments on evidence. Data sharing should boil down to the data itself. There is no point in constructing a narrative if one does not have the data to back it up. Birney declares: “Evidence is beautiful.”