A recent study published in The New England Journal of Medicine brought encouraging news for colon cancer patients: by using gene-expression analysis and bioinformatic tools, researchers had found a candidate biomarker that could potentially identify high-risk individuals who would benefit from adjuvant chemotherapy. This is where data from previous clinical trials came in handy: the biomarker was validated in a heterogeneous patient population combined from four retrospective study cohorts.
This study is just one great example on how data sharing can be used to confirm hypotheses and expedite progress in research. In addition to scientific benefit, efforts on data sharing will bring visibility to all parties involved.
The concept of data sharing is an excellent opportunity for pharmaceutical companies to stand out. Transparent communication with both academic researchers and the public helps build better trust and growing interest in clinical trials sponsored by the industry. In turn, this could further increase research resources and thus benefit the whole biomedical field—from academic research institutions to industry.
Data sharing is here to stay
By now, studies based on industry-sponsored data resourceshave compared treatments for epilepsy, investigated the safety of anticoagulants, and hunted for novel biomarkers for various diseases, to name few examples.
In 2004, GlaxoSmithKline became the first pharmaceutical company to voluntarily share its clinical trial information. Now the Clinical Study Data Request resource, which was launched in 2013, has received almost 200 research proposals. Several other companies including Bayer, Lilly, Roche, and Takeda have joined the platform, and together they seek to maximize the effect of clinical trials, as the web resource outlines:
“Access to clinical trial data provides opportunities to conduct further research that can help advance medical science or improve patient care. This helps ensure the data provided by research participants are used to maximum effect in the creation of knowledge and understanding.”
Urgent need for global standards
This growing trend will also bring global challenges. A recent report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk by the National Academy of Sciences, summarizes: “The issue is no longer whether to share clinical trial data, but what specific data to share, at what time, and under what conditions.”
To succeed, the global community needs standard approaches to solve the key questions: Do the researchers understand the limitations of individual data sets? What data can be compared? Who takes the credit? Is the anonymity of the patients secured? These and other issues as well as suggestions for solving them are discussed in the aforementioned report.
Change is in the air
Recently, regulatory agencies and publishers have also joined the initiative to build a more dynamic and open research environment. A growing proportion of the 210,000 studies registered on ClinicalTrials.govinclude results to be shared with the public and scientific community. The European Medicines Agencyhas also been actively implementing strategies for more open data sharing.
Meanwhile, the recent Ebola and Zika outbreaks have also created an urgent need for free access to publicationsand the data behind them. As a response, a mandatory data-sharing requirementfor publishing clinical trials could also be requested from top journals such as The British Medical Journal, The New England Journal of Medicine,and The Lancetin the very near future.
Collectively, these aspects offer pharmaceutical industry a great opportunity to lead the way for transparent and effective data sharing. It is also likely that this will generate a need for new business models bridging partners across the field.
By enhancing collaboration between academic institutions, investors, and industry, data sharing will very likely change how biomedical research is done in the future.