On July 6, 1885 Louis Pasteur, a French chemist and biologist, administered his recently discovered rabies vaccine for the first time to Joseph Meister, a nine-year-old boy who had been attacked by a rabid dog.
Fortunately for Pasteur, the vaccine proved effective – saving Meister’s life, allowing Pasteur to be celebrated as a national hero and ushering in the era of preventative medicine. However, if Pasteur’s test had failed, he might have been prosecuted for administering the vaccine without a license to practice medicine!
A researcher injecting a vaccine developed in his own lab with no physician oversight, widespread testing, collection of data and sharing of information with other researchers, would never happen today – which is good for all of us.
Clinical trials are an important part of the drug development process to ensure safety and efficacy of the treatment. Management of clinical trials involves a myriad of organizations, physicians and researchers – each with their own information system that may or may not communicate easily with each other.
According to a report in American Pharmaceutical Review, the 2016 Nice Insight CRO Outsourcing Survey showed that 50 percent of data management responsibilities for clinical trials are outsourced to Contract Research Organizations (CROs). Other studies have placed the percentage of data management responsibilities outsourced to CROs at as high as 68 percent.
With a wide range of sizes and capabilities, CROs may not have the systems in place to translate data into a format that the life sciences organization requires. If the life sciences company is managing the trial in-house, communication with provider organizations that have disparate electronic health records systems adds to the data-sharing challenges.
While increased testing and more data from clinical trials better ensures the safety and effectiveness of drugs today, pharmaceutical companies must also work to balance these benefits against the increased time and expense required for today’s more thorough approach. Pasteur was able to get his vaccine into the hands of users considerably more quickly and for less cost, though at much greater risk.
The inability to handle large amounts of data in multiple formats is one reason for delayed time to market, compliance failures and increased costs of drug development. With the cost of bringing products to market already $1.3 to $5.8 billion, addressing interoperability and data integration issues becomes a priority – especially as more services are outsourced and more partners are engaged.
Technology platforms that enable clinical trial research partners to submit data in native form to be translated into the pharmaceutical partner’s required format save time and reduce errors. Relying on Liaison’s cloud-based ALLOY™ Platform for Healthcare to aggregate, translate and integrate data into formats needed by each individual researcher or organization enables seamless sharing of data in any format.
Unlike Pasteur, we are lucky to live in a time that allows researchers to share information easily and to gather information from clinical trial patients that can be used to improve treatments, and do this in a timely manner.
Even before clinical trials are established, scientists have access to information from EHRs, other trials, other research, and other sources that can help them better focus their efforts to produce effective medications. Also, we are fortunate to have the technology and tools to harness the power of this information to generate ideas and implement innovative approaches that improve all of our lives.
Is your life sciences organization inoculated against an inability to share data seamlessly with all research partners?