The statistics are overwhelming. Every successfully approved FDA treatment starts with the researching of thousands of potential treatments, can take anywhere from four to eight years of research and 1 to 2 years of FDA review, and cost upwards of $500 million to $1 billion dollars to bring to market. Thus forms the foundational argument for reducing the cost and complexity of clinical trials.
The time and cost of new treatment research has become so onerous that it prompted the U.S. Energy & Commerce Committee to create the 21st Century Cures Initiative, a bipartisan effort to identify actions that Congress can take to accelerate the development and approval of new treatments. Their goal is to use the information they uncover to develop legislation that helps introduce new cures faster and more cost-effectively.
On July 9, 2014, experts in clinical trials design and execution testified before the committee on ways to modernize clinical trials. While there were many recommendations, the consensus of most of those testifying was that driving interoperability among systems and data is the most effective way to improve the process. Since then, the idea of interoperable systems and data has gained momentum. Unfortunately, there has been little movement in the 9 months since the hearing in defining and implementing interoperability standards.
The typical Clinical Research organization (Sponsors, CRO’s, etc) use a dozen different systems in support of clinical trials. While CDISC addresses a major portion of the actual field definitions as a standard, there are no standards on how they should share data. These disparate systems often cause more work and introduce the possibility of more error. The systems become just another obstacle in a long, expensive, and onerous process.
Emerging data architecture standards are starting to make inroads in data interoperability. The ability to share information among systems supporting a common objective (e.g., conducting a clinical trial) is improving. But these systems do not exist in a vacuum. They eventually require data from sources outside the strict definition of clinical trials. While pharmacy management systems are not core to the clinical trials process, they nonetheless impact the process when study participants require prescription medications along with the new compounds.
Adopting standards such as Health Level 7 (HL7) and the Clinical Data Interchange Standards Consortium (CDISC) is an important step in attaining interoperability. But standards in and of themselves are not enough. They simply expedite an export/import process that moves data among systems. True interoperability requires a seamless and automated process that makes data shareable and accessible across systems and platforms without the need for additional steps.
Furthermore, interoperability among systems requires a commitment to transparency that some vendors resist. “Protecting their turf” by creating proprietary structures trumps sharing data in an open format. The irony is that resisting interoperability is the precursor to obsolescence. Vendors who embrace the ideal of interoperability will ultimately prevail.
As complex as the clinical trials stage is, it is only one piece of a much broader puzzle for developing, approving, manufacturing, marketing, and delivering new products. Data is reused – often by being manually reentered – among different applications throughout the process. True interoperability would eliminate the need for manual reentry in all systems that support all phases, from investigation to marketing and delivery. The pharmaceutical industry, in conjunction with Congress, continues to demand interoperability among systems as a critical component of reducing the time, cost, and complexity of new drug approvals. Vendors who offer outstanding service and functionality with a commitment to creating interoperable platforms will ultimately drive the changes required to streamline the clinical trials process.