TransCelerate BioPharma is launching two new global initiatives enabled by broad participation and collaboration across the R&D community: to develop a position on the best and most efficient methods for redacting privacy information found in clinical study reports and an approach for the anonymization of patient-level data shared with the broader healthcare community; and to develop a framework for a Quality Management System (QMS) specifically for clinical research to improve the quality and efficiency of clinical trials.
These new initiatives, in addition to the current eight, will further the TransCelerate vision to improve the health of people around the world by accelerating and simplifying the research and development of innovative new therapies.
The Clinical Data Transparency initiative was created to explore developing a position paper on the best and most efficient methods for redacting privacy information found in CSRs. It seeks to respond to other trade organizations' positions regarding this matter, including the positions set out in response to the EFPIA/PhRMA Principles for Responsible Clinical Trial Data Sharing around sharing of CSRs. TransCelerate's members have worked to identify the instances and methods for redaction to preserve the privacy of patients, investigators and clinical trial staff. The approach was shared with senior representatives of the European Medicines Agency (EMA). The team will continue to work collaboratively to develop the principles for the writing of future CSRs, as well as an approach for the anonymization (and de-identification) of patient-level data shared with the broader healthcare community.
Quality Management Systems are increasingly and successfully being used in other industries, as well as in pharmaceutical manufacturing, to control quality and improve performance in complex environments. Modern clinical research has become more complex due to globalization, higher regulatory standards and the nature of the diseases targeted. As Quality Management Systems used in manufacturing and other areas cannot be directly applied to clinical research, TransCelerate has decided to develop a framework for a QMS specifically for clinical research to improve the quality and efficiency of clinical trials, while further increasing patient safety. It will work closely with global regulatory agencies, which increasingly are advocating a quality management system approach, not only for pharmaceutical manufacturing but also clinical research. The Clinical Research QMS framework will focus on common, recurring quality issues that regulatory agencies have been pressuring the industry to resolve.
"With the launch of these new projects, we continue to tackle areas of R&D inefficiency and common need," said Dalvir Gill, Ph.D., CEO of TransCelerate. "The Clinical Data Transparency project is an excellent example of TransCelerate member companies working together in response to a common need rather than each addressing it individually."
In addition to launching these new initiatives, TransCelerate has filled two open seats on its board of directors: Iris Low-Friedrich, executive vice president, Biopharma Development Solutions, chief medical officer and executive committee member, will represent UCB; and Takuko Yamada-Sawada, senior executive officer, head of global development and corporate executive committee member, will represent Shionogi.
Membership in TransCelerate is open to pharmaceutical and biotechnology companies with R&D operations.
TransCelerate BioPharma is a nonprofit dedicated to improving the health of people around the world by accelerating and simplifying the R&D of innovative new therapies. The organization's mission is to collaborate across the global R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high-quality delivery of medicines.