A new report published by Georgetown University with support from a US Food and Drug Administration (FDA)-funded project calls for wider sharing of regulatory data in the hopes of enhancing the development of new products.
The report, Facilitating Medical Product Development Through Voluntary Data Sharing, makes the argument that "wide sharing of research data would be good for scientific discovery and the enterprise of medical product development as well as public health."
"Since data should drive decision-making, data sharing becomes a powerful tool for informing research, inspecting the evidence and generating knowledge applicable to the public good," the authors of the report write.
Currently, much of the regulatory data used to support new product applications is confidential, the report notes. With the exception of the European Medicines Agency (EMA), which recently instituted new measures intended to make regulatory data significantly more transparent, most global regulators protect data as commercially confidential information (CCI). "These provisions protect the innovators, including the proprietary nature of the data and attendant trade secrets," the report explains.
While there are benefits to this approach—it incentivizes the collection of thorough (and expensive) data and protects patient confidentiality, especially in disease areas with small populations—the authors of the report argue the benefits of data sharing stand to far outweigh its risks.
The core of the report's argument is that additional sharing of data will result in less wasteful research, faster innovation, innovation in new areas and more profitable product launches (by reducing research waste).
In plain terms, by sharing research with one another, companies will be able to better understand which approaches work, which research is—and is not—worth pursuing, which research doesn't need to be re-validated, and which shortcuts can be taken based on past research, the report claims.
But industry, the report notes, is more than a little wary about moving in this direction.
"Our preliminary qualitative research revealed that many of the cited concerns about data sharing were not based on actual data-sharing experiences gone awry," the authors of the report wrote. "Instead, fears were driven from the understanding that data – and subsequent intellectual property – are the currency with which corporate and academic research institutions conduct business."
However, the report notes that despite many companies being hesitant to share all data, many are willing to share some data—just as long as it's shared with the right people.
"The arrangements that seemed most plausible to participants involved groups of carefully vetted individuals with clearly defined roles, managed by an impartial and independent third party, to ensure relevance of data and fairness among competitors," the report notes. "The types of data that would be most readily shared included safety, pre-clinical, and placebo or control datasets."
This arrangement is at least philosophically in line with the new data transparency policies put forth by EMA, which is meant to bar any use of the data for commercial purposes. Access to the data, however, is not limited to the "carefully vetted individuals" for which the pharmaceutical industry has expressed its preference.
The extensive report also breaks down some of the barriers to sharing data in the US, including intellectual property laws, legal liability laws, antitrust laws and privacy laws.
The report was supported by Georgetown's Center of Excellence in Regulatory Science and Innovation (CERSEI), which has significant financial support from FDA.
Facilitating Medical product Development Through Voluntary Data Sharing