Why data sharing should be the expected norm

Further to go

Those of us who are eager for a change in the scientific culture remain impatient for even more progressive action plans. The harms of not reporting results and not sharing data are well established.8 9 But people who continue to caution about the harms of data sharing have yet to provide persuasive examples where data sharing has harmed the public.

Among other problems, the absence of data sharing creates the important problem of information asymmetry among researchers. Those with the data can assert authority over interpretation and diminish the ability of others to debate key points, muffling scientific discourse. Confirmation bias can lead a group of investigators to see their data through a particular lens, while others could reasonably interpret the data differently and provide another perspective. Even independent expert reviewers come to different conclusions when provided with the same individual patient level data.10

One of the peculiarities of clinical research is the challenge of replicating a study. A tenet of the scientific method is reproducibility. And yet, for clinical trials, reproducibility is often precluded by cost or logistic, ethical, or business reasons. As a result, direct replication by repeating the experiment in a different laboratory is not an option. This constraint makes it even more important that independent scientists can study the raw data.

Challenges surrounding replication are not unique to medicine. It is not feasible to independently repeat experiments conducted with the Hubble telescope or the Hadron collider. Instead, astronomy and physics researchers conduct an experiment and then share the results widely for scientists to study and produce more knowledge and insight. Such collaboration strengthens the trust in research, expands the volume of research that can derive from single experiments, and includes investigators who otherwise would be unable to fund such experiments. Unfortunately, what occurs every day in medical research is akin to a few astronomers with access to the most powerful telescope interpreting for us what they saw without allowing us to look for ourselves.

Signs of progress

Fortunately, in medicine, the remedies to the current culture are coming. Industry is already making voluntary major steps to share data. Concurrent with the release of the IOM report, Johnson and Johnson, with the Yale Open Data Access (YODA) project, agreed to release its medical device trial data going forward, the first commitment to a broad release of that type of data.11 Johnson and Johnson, along with other major companies, is already releasing data from drug trials.2 3 There is some variation among companies and many data remain out of public view, but there is notable progress. The United States National Institutes of Health responded to concerns about non-publication and is receiving public comment on a rule requiring reporting of its studies.5 The agency’s next step should be to promote sharing of raw data. The Gates Foundation, in the most audacious show of leadership, stated that it will soon require data sharing at the time of publication.6

Yet it will take more to transform the current culture and we need to move quickly.8 9 All trials should be reported promptly after study completion and, if possible, published in peer reviewed journals. And any data generated in the course of medical research that might help fight disease and alleviate suffering should be shared as soon as possible. To delay knowledge generation by restricting access to such data should be considered counter to medical research’s code of responsible and civil conduct. Solving the health problems that patients face must prevail over the self serving desire to treat data as hoarded treasure.

Yes, there are challenges. We need financial support for data sharing in grants. Academics must find ways to credit those who produced the data. Companies need time to get their products approved. And there are others. But time wasted in reporting and sharing can cost lives, and we need to push forward. We should heed the implicit message that the Gates Foundation is sending: solving the world’s health problems is more important than protecting the opportunity for researchers to have exclusive access to data. It’s time for us to create a collaborative scientific culture in which investments in trials are leveraged through sharing with the broader community and to move past the reasons for why doing so is hard.