As the life sciences industry has evolved, so too have the requirements for greater transparency in development activities. Healthcare consumers around the globe are demanding more information about study outcomes and planned future activities—and regulatory bodies have bowed in turn, adding new guidelines to ensure compliance.
In July 2013, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies committed to “Principles for Responsible Clinical Trial Data Sharing.” This included a commitment to enhance public access to clinical study information. The European Medicines Agency (EMA) has also been developing legislation, and in June 2013 this process resulted in the publication of a draft policy document titled “Publication and access to clinical-trial data.” In May 2014, a draft policy for Redaction Principles was also released. All of these potential new policies are under review, but are not yet final due to concerns from various stakeholders.
There will be some give and take about the specifics of these guidelines, but ultimately greater visibility will become mandatory. Pharmaceutical and biotechnology companies have been following these developments closely and are attempting to align their processes and workflows accordingly so they will be ready to meet the requirements once they take effect. This has led to life sciences industry organizations such as Transcelerate to provide recommendations for Clinical Study Report (CSR) redaction that could be used as a guideline for companies that begin to undertake this process.
Regardless of how these pending policies ultimately turn out, greater transparency is good for the public. The researchers who create new therapies, the subjects who participate in studies, and the patients who ultimately take the approved product can all use the information to make more informed decisions. What seems to still be lacking is most companies have not thought through how they are going to share this data with subjects and patients who require information in languages other than English. Companies who are looking to address these challenges should ask themselves the following questions:
Are we going to make the CSRs and other documentation available to the public in their language?
Should we proactively translate the information once we have received regulatory approval or do it as each CSR is completed?
Should we wait until an individual requests the documentation in their language and if so what is that process?
Do we make the information available on our product/company website or do we develop a portal to share this information?
These are all critical questions and ones that need to be decided by the senior management at each company, looking through a risk-based lens as they assess what is in the best interest of research subjects and patients. TransPerfect finds most companies need support in global redaction and translation processes, and we have developed best practices and technologies to help. Through our new TransParency initiative, we are happy to consult with global life sciences companies to ensure they are adequately prepared for these new and impending regulations and policies.